Brief psychosocial education, not core stabilization, reduced incidence of low back pain : results from the Prevention o...

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Title:
Brief psychosocial education, not core stabilization, reduced incidence of low back pain : results from the Prevention of Low Back Pain in the Military (POLM) cluster randomized trial
Series Title:
BMC Medicine
Physical Description:
Mixed Material
Language:
English
Creator:
George, Steven Z.
Childs, John D.
Teyhen, Deydre S.
Wu, Samuel S.
Wright, Alison C.
Dugan, Jessica L.
Robinson, Michael E.
Publisher:
BioMed Central
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Subjects / Keywords:
primary prevention
core stabilization
patient education
incidence
low back pain

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Abstract:
Background: Effective strategies for the primary prevention of low back pain (LBP) remain elusive with few largescale clinical trials investigating exercise and education approaches. The purpose of this trial was to determine whether core stabilization alone or in combination with psychosocial education prevented incidence of low back pain in comparison to traditional lumbar exercise. Methods: The Prevention of Low Back Pain in the Military study was a cluster randomized clinical study with four intervention arms and a two-year follow-up. Participants were recruited from a military training setting from 2007 to 2008. Soldiers in 20 consecutive companies were considered for eligibility (n = 7,616). Of those, 1,741 were ineligible and 1,550 were eligible but refused participation. For the 4,325 Soldiers enrolled with no previous history of LBP average age was 22.0 years (SD = 4.2) and there were 3,082 males (71.3%). Companies were randomly assigned to receive traditional lumbar exercise, traditional lumbar exercise with psychosocial education, core stabilization exercise, or core stabilization with psychosocial education, The psychosocial education session occurred during one session and the exercise programs were done daily for 5 minutes over 12 weeks. The primary outcome for this trial was incidence of low back pain resulting in the seeking of health care. Results: There were no adverse events reported. Evaluable patient analysis (4,147/4,325 provided data) indicated no differences in low back incidence resulting in the seeking of health care between those receiving the traditional exercise and core stabilization exercise programs. However, brief psychosocial education prevented low back pain episodes regardless of the assigned exercise approach, resulting in a 3.3% (95% CI: 1.1 to 5.5%) decrease over two years (numbers needed to treat (NNT) = 30.3, 95% CI = 18.2 to 90.9). Conclusions: Core stabilization has been advocated as preventative, but offered no such benefit when compared to traditional lumbar exercise in this trial. Instead, a brief psychosocial education program that reduced fear and threat of low back pain decreased incidence of low back pain resulting in the seeking of health care. Since this trial was conducted in a military setting, future studies are necessary to determine if these findings can be translated into civilian populations. Trial Registration: NCT00373009 at ClinicalTrials.gov - http://clinicaltrials.gov/ Keywords: primary prevention, core stabilization, patient education, incidence, low back pain

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University of Florida
Holding Location:
University of Florida
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All rights reserved by the source institution.
Resource Identifier:
doi - 10.1186/1741-7015-9-128
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AA00010460:00001


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Briefpsychosocialeducation,notcore stabilization,reducedincidenceoflowbackpain: resultsfromthePreventionofLowBackPainin theMilitary(POLM)clusterrandomizedtrialGeorge etal George etal BMCMedicine 2011, 9 :128 http://www.biomedcentral.com/1741-7015/9/128(29November2011)

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RESEARCHARTICLE OpenAccessBriefpsychosocialeducation,notcore stabilization,reducedincidenceoflowbackpain: resultsfromthePreventionofLowBackPainin theMilitary(POLM)clusterrandomizedtrialStevenZGeorge1,7*,JohnDChilds2,3,DeydreSTeyhen3,4,SamuelSWu5,AlisonCWright3,JessicaLDugan3and MichaelERobinson6,7AbstractBackground: Effectivestrategiesfortheprimarypreventionoflowbackpain(LBP)remainelusivewithfewlargescaleclinicaltrialsinvestigatingexerciseandeducationapproaches.Thepurposeofthistrialwastodetermine whethercorestabilizationaloneorincombinationwithpsychosocialeducationpreventedincidenceoflowback painincomparisontotraditionallumbarexercise. Methods: ThePreventionofLowBackPainintheMilitarystudywasaclusterrandomizedclinicalstudywithfour interventionarmsandatwo-yearfollow-up.Participantswererecruitedfromamilitarytrainingsettingfrom2007 to2008.Soldiersin20consecutivecompanieswereconsideredforeligibility(n=7,616).Ofthose,1,741were ineligibleand1,550wereeligiblebutrefusedparticipation.Forthe4,325Soldiersenrolledwithnoprevioushistory ofLBPaverageagewas22.0years(SD=4.2)andtherewere3,082males(71.3%).Companieswererandomly assignedtoreceivetraditionallumbarexercise,traditionallumbarexercisewithpsychosocialeducation,core stabilizationexercise,orcorestabilizationwithpsychosocialeducation,Thepsychosocialeducationsession occurredduringonesessionandtheexerciseprogramsweredonedailyfor5minutesover12weeks.Theprimary outcomeforthistrialwasincidenceoflowbackpainresultingintheseekingofhealthcare. Results: Therewerenoadverseeventsreported.Evaluablepatientanalysis(4,147/4,325provideddata)indicated nodifferencesinlowbackincidenceresultingintheseekingofhealthcarebetweenthosereceivingthetraditional exerciseandcorestabilizationexerciseprograms.However,briefpsychosocialeducationpreventedlowbackpain episodesregardlessoftheassignedexerciseapproach,resultingina3.3%(95%CI:1.1to5.5%)decreaseovertwo years(numbersneededtotreat(NNT)=30.3,95%CI=18.2to90.9). Conclusions: Corestabilizationhasbeenadvocatedaspreventative,butofferednosuchbenefitwhencompared totraditionallumbarexerciseinthistrial.Instead,abriefpsychosocialeducationprogramthatreducedfearand threatoflowbackpaindecreasedincidenceoflowbackpainresultingintheseekingofhealthcare.Sincethis trialwasconductedinamilitarysetting,futurestudiesarenecessarytodetermineifthesefindingscanbe translatedintocivilianpopulations. TrialRegistration: NCT00373009atClinicalTrials.gov-http://clinicaltrials.gov/ Keywords: primaryprevention,corestabilization,patienteducation,incidence,lowbackpain *Correspondence:szgeorge@phhp.ufl.edu1DepartmentofPhysicalTherapy,POBox100154,UniversityofFlorida, Gainesville,FL,32610USA FulllistofauthorinformationisavailableattheendofthearticleGeorge etal BMCMedicine 2011, 9 :128 http://www.biomedcentral.com/1741-7015/9/128 2011Georgeetal;licenseeBioMedCentralLtd.ThisisanOpenAccessarticledistributedunderthetermsoftheCreativeCommons AttributionLicense(http://creativecommons.org/licenses/by/2.0),whichpermitsunrestricteduse,distribution,andreproductionin anymedium,providedtheoriginalworkisproperlycited.

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BackgroundMusculoskeletalpain,andespeciallylowbackpain (LBP),adverselyaffectsmilitarypreparednessascommonreasonsformedicalevacuation[1]withreturnto dutybeinguncertain[1,2].Furthermore,LBPisalsoa commonreasonforlong-termSoldierdisability[3].Itis notsurprisingthenthatpreventionofLBPremainsa highresearchpriorityforthegeneral[4]andmilitary societies[1,2]. EffectivestrategiesforpreventingLBPremainelusive. Physicalexercisehasconsistentevidenceforprimary preventionofLBPcomparedtonoactivity[5],buta reviewfortheEuropeanGuidelinesforPreventionof LowBackPainindicatedtherewerenotenoughstudies toallowforrecommendationsdifferentiatingtypesof exercise[6].Backschools, lumbarsupportsandergonomicinterventionshavelimitedsupportinsystematic reviews[5,7],and,therefore,arenotrecommendedfor primarypreventionofLBP[6].Educationforprimary preventionofLBPhasreceivedmixedsupportintrials [5];therehasbeensomesupportforpsychosocialeducation,butnotforbiomedicalorbiomechanicalbased educationprograms[6].PrioritiesforLBPprevention researchnotedintheEuropeanGuidelinesincluded higherqualityrandomizedtrialsthatinvestigatedspecificphysicalexerciseinterve ntionsincombinationwith psychosocialeducation[6]. ThePreventionofLowBackPainintheMilitary (POLM)clusterrandomizedc linicaltrialincorporated corestabilizationexercisebecauseofitspreventative potential[8,9].WealsoincorporatedpsychosocialeducationbasedontheFear-AvoidanceModelofMusculoskeletalPain(FAM)[10,11].EarlierPOLMstudies reportedourcorestabilizationprogramwasassociated withshorterworkrestrictionfromLBP[12],andthe psychosocialeducationprogramresultedinapositive shiftinSoldierbackbeliefs[13].Plannedfutureanalyses ofthePOLMtrialincludeinvestigationofhowcorestabilizationexerciseaffectsactivationofkeylumbarmusculature,predictorsoffirstepisodeofLBP,andan economicanalysisoftheseinterventions. ThecurrentpaperthenreportsontheprimaryfindingsofthePOLMclusterrandomizedtrial.ThePOLM trialhadfourinterventionarmsconsistingoftraditional lumbarexercise,traditionallumbarexercisewithpsychosocialeducation,corestabilizationexercise,andcore stabilizationexercisewithpsychosocialeducation groups.Theseinterventiongroupswerecomparedfor theireffectsinpreventingLBPduringtwoyearsofmilitaryduty.ThePOLMtrial saimswereconsistentwith previouslymentionedprimarypreventionprioritiesand weinvestigatedindividualleveleffectsofexerciseand educationprograms.WehypothesizedthatSoldiers receivingcorestabilizationandpsychosocialeducation wouldhavelowerincidenceofLBPincomparisonto thosereceivingonlytraditionallumbarexercise.MethodsTheinstitutionalreviewboardsattheBrookeArmy MedicalCenter(FortSamHouston,Texas)andtheUniversityofFlorida(Gainesville,FL)grantedethical approvalforthisproject.AllSoldiersprovidedwritten informedconsentpriortotheirparticipation.Amore detaileddescriptionofthePOLMtrialprotocolhas beenpreviouslypublished[14].Datainthispaperwere reportedincompliancewiththeConsolidatedStandards ofReportingTrials(CONSORT)guidelinesextension forclusterrandomizedtrials[15].SubjectsConsecutiveSoldiersenteri nga16-weektrainingprogramatFortSamHouston,TXtobecomecombatmedicsintheU.S.Armywereconsideredforparticipationin thePOLMtrialfromFebruary2007toMarch2008. Thistrainingprogramoccurredaftercompletionof basictraining. Subjectswererequiredtobe18to35yearsofage(or 17-year-oldemancipatedminors)andbeabletospeak andreadEnglish.SubjectswithapriorhistoryofLBP wereexcluded.ApriorhistoryofLBPwasoperationally definedasLBPthatlimitedworkorphysicalactivity, lastedlongerthan48hours,andcausedthesubjectto seekhealthcare.Subjectswerealsoexcludedifthey werecurrentlyseekingmedicalcareforLBP;unableto participateinunitexerciseduetomusculoskeletal injury;hadahistoryoflowerextremityfracture(stress ortraumatic);werepregnant;orhadtransferredfrom anothertraininggroup.Otherpossibleexclusions includedSoldierswhowerebeingacceleratedintoa companyalreadyrandomizedorSoldierswhowere beingre-assignedtoadifferentoccupationalspecialty.ExerciseprogramsSubjectsperformedtheassignedgroupexerciseprogram underthedirectsupervisionoftheirdrillinstructorsas partofdailyunitphysicaltraining.Specifically,the entirecompanyexercisedatthesametimewitheach individualplatoonbeingledbyoneofsixdrillsergeants assignedtoaparticularplatoonforthetrainingperiod. Therefore,theseexercisep rogramsarelikelytopertain toindividual,platoonandcompanylevels.Thetraditionalexerciseprogram(TEP)wasselectedfromcommonlyperformedexercisesfortherectusabdominus andobliqueabdominalmuscles.Theseexercisesare routinelyperformedinside(andoutside)themilitary environmentandareutilizedtoassessphysicalGeorge etal BMCMedicine 2011, 9 :128 http://www.biomedcentral.com/1741-7015/9/128 Page2of11

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performanceofSoldiers[16].Corestabilizationexercise approachesdifferinthattheytargetdeepertrunkmusclesthatattachtothespine;suchasthetransversus abdominus,multifidusandtheerectorspinae.Thesemusclesplayakeysupportiverolethatcontributetotheability ofthelumbarspinetowithstandloading[17,18]andexercisesthattargetthesemusclesarebelievedtohavepreventativeeffectsforLBP[8,9].Thecorestabilizationexercise program(CSEP)usedinthePOLMtrialconsistedofexercisesshownwithpotentialtoselectivelyactivatethese samemusclegroupstodirectlytestthesepurportedpreventativeeffects.TheTEPandCSEParedescribedin Table1andinmoredetailinpreviousPOLMpublications [12,16].TheTEPwasanactivecomparisontreatment conditionbecauseano-exerciseinterventiongroupwas notfeasibleinthemilitaryenvironment. TheTEPandCSEPexerciseregimensconsistedoffive tosixexercises,eachofwhichwasperformedforone minute.Exerciseprogramswereperformeddaily,fora totaldosagetimeoffiveminutesperday,fivedaysper weekover12weeks.Studypersonnelmonitoredphysicaltraininganaverageoftwodaysperweekoverthe 12-weektrainingperiodtoanswerquestionsandmonitorcompliancewiththeassignedexerciseprogram.BriefeducationprogramThebriefpsychosocialeducationprogram(PSEP) involvedattendanceatonesessionduringthefirstweek oftraining.Fortheeducationprogram,thecompany wasdividedintotwoorthreegroupstoaccommodate thesizeofthelecturehallandalsotoallowforflexibilityinschedulingSoldiers.Eachgroupreceivedthesame informationandthesessioninvolvedaninteractivelectureledbystudypersonnel(ACW,JLD)lastingapproximately45minutes.Thelectureconsistedofavisual presentationfollowedbyaquestionandanswersession. ThePSEPprovidedSoldierscurrent,evidence-based informationonLBPthatwasdesignedtoreduceits threatandfear,suchasstressingthatanatomicalcauses ofLBParenotlikelytobedefinitelyidentifiedand encouragingactivecopingstr ategies.EducationalmaterialwasprovidedbyissuingeachSoldier TheBackBook forpersonaluseashasbeendoneinprevioustrials [19-21].ThePSEPisdescribedinmoredetailinapreviousPOLMpublication[13].Wedidnotincludea controleducationprogramaspriorstudiesconsistently demonstratedcomparisoneducationapproachesdidnot favorablyalterLBPbeliefs[19,20].RandomizationMilitarytrainingenvironm entsrequirelivinginclose quarterswithothermembersoftheunit,makingindividualrandomizationanunfeasibleoptionduetotreatmentcontamination.Therefore,aclusterrandomization strategywasutilizedasthisisaviablemethodological choiceforlargeprimarypreventiontrials[22,23].The POLMtrialhadfourinterventionarmscomprisedofa combinationofthepreviouslydescribedexerciseand educationprograms.ThespecificinterventioncombinationsforclusterrandomassignmentincludedTEPonly, TEP+PSEP,CSEPonly,andCSEP+PSEP. Therandomizationschedulewaspreparedbycomputeranddeterminedbeforerecruitmentbegan.Therandomizationschedulewasbalancedtoensurethatequal numberofcompanieswasallocatedtoeachprogram. Treatmentallocationwasdoneinaconcealedmanner attheUniversityofFloridaandthisprocesswassupervisedbyourleadstatistician(SSW).Therandomlygeneratedinterventiongroupswerecompletedpriorto studyrecruitmentandlistedinsequentialorder.This listwasthenstoredonasecureserverattheUniversity ofFlorida.Whenanewcoho rtofSoldierswasscheduledtostarttheir12-weektrainingprogramthestudy coordinatorsatBrookeArmyMedicalCenter(ACW, JLD)contactedresearchpersonnelattheUniversityof Floridafortheappropriateinterventionassignment.BlindingItwasnotpossibletomaskSoldiersbecausethey activelyparticipatedintheexerciseandeducation Table1Descriptionofcorestabilization(CSEP)traditional(TEP)andexerciseprogramsExercise CSEP TEP Principle Lowerload,lessrepetitions Higherload,morerepetitions Activation Slower Faster Trunkmovements Nonetominimal Full Dosage Fiveminutes/day Fiveminutes/day #1 Abdominaldrawing-inmaneuvercrunch Traditionalsit-up #2 Leftandrighthorizontalsidesupport Sit-upwithlefttrunkrotation #3 Hipflexorsquat Sit-upwithrighttrunkrotation #4 Supineshoulderbridge Abdominalcrunch #5 Quadrupedalternatearmandleg Traditionalsit-upCSEP,corestabilizationexerciseprogram;TEP,traditionalexerciseprogramGeorge etal BMCMedicine 2011, 9 :128 http://www.biomedcentral.com/1741-7015/9/128 Page3of11

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trainingprograms.Alloutcomeswereassessedbyraters blindedtogroupassignmentorwereobtainedviaselfreport.BaselinemeasuresMeasureswerecollectedunde rsupervisionofresearch personnelunawareofrandomcompanyassignmentand scoredinamaskedmannerbycomputeralgorithm.Soldierscompletedstandarddemographicinformation, suchasage,sex,pastmedicalhistory,andfactorsrelated tomilitarystatus.Soldiersalsocompletedself-report measuresatbaselineforphysicalandmentalfunction [24],anxiety[25],depressivesymptoms[26],fearofpain [27],andbackbeliefs[28].OutcomemeasuresWeoriginallyintendedtoassessself-reportofLBPincidenceusingaweb-baseddatacollectionsystem,in whichSoldierswereremindedbyemailtocompleteonlineformsaboutwhethertheyhadexperiencedLBPin thelastcalendarmonth[14].However,oneyearfollowupratesweremuchlowerthananticipated(18.4%)[29]. Exactreasonsforthelowfollow-upratefromtheselfreportmethodwereunknownbutitcouldhavebeen duetodeploymenttoIraqorAfghanistanlimitingabilitytoaccesstheweb-basedsystem.AtoneyearfollowupadecisionwasmadetoinsteadmeasureLBPincidencebytrackingSoldiersthatsoughthealthcarefor LBP.Therefore,theprimaryoutcomeforthisstudyis bestconceptualizedasincidenceofLBPthatresultedin theseekingofhealthcare.Thisdecisiontochangethe methodofmeasuringincidencewasbasedsolelyon concernswithlowfollow-upratesnoticedbeforethe primarystudyendpoint[29].Thestudyteammadethe decisionwithoutthebenefitofpreliminaryanalysesand healthcareutilizationwasnotoriginallyasecondary outcome.Furthermore,onlyahealthcareutilization databasewasconsideredasthemeanstogeneratean alternatemeasureforLBPincidence.Thedecisionto useahealthcareutilizationdatabasetomeasureLBP incidencewasreinforcedwhenthefinaltwo-yearselfreportresponserateremainedlowat1,230/4,325 (28.4%). TheMilitaryHealthSystem(MHS)ManagementAnalysisandReportingTool(M2database)wasusedto determineLBPincidencemainlybecauseofitscomprehensivenatureincapturing healthcareutilization.Our interestinusingahealthcareseekingdefinitionof experiencingLBPwasdrivenbystudiesindicatingcontinuinghighratesofhealthcareutilizationforLBP [30,31]withtrendsofgreatlyincreasingcost,butofno obviousbenefittothepopulation[32,33].Inaddition, thevalidityofself-reportmeasuresfordeterminingLBP hasbeenquestionedformilitarypopulations[34],and useofahealthcaredatabasemitigatedtheseconcerns. TheM2databaseismaintainedbytheTricareManagementActivityoftheMHSandcontainsavarietyof healthcaredataregardingpatientcarefromboththe directcaresystem(careprovidedinmilitarytreatment facilities)andnetworkcare(careprovidedtoMHSbeneficiariesatcivilianfacilities)worldwide.Additionally, thedatacollectedtopopulatetheM2databaseincludes healthcareusewhileSoldiersaredeployedtosuchareas asIraqorAfghanistan.TheM2databasewassearched forrelevantLBP-relatedInternationalClassificationof Diseases(ICD)codesforSoldiersenrolledinthePOLM trial.Weusedsimilarstrategiestooperationallydefine LBPashasbeenpublishedinotherstudies,usingICD codestoidentifysubjectsseekinghealthcareforLBP [35,36].Wehadoriginallyplannedtoinvestigatethe severityofthefirstLBPepisodebuttheM2database didnotincludemeasuresthatallowedforsuchanestimate.Therefore,theseverityofLBPoutcomemeasure wasabandonedfromthereportingofPOLMtrialprimaryresults.SamplesizeestimationandpoweranalysisThistrialintendedtorecruitaminimumof16companiesbasedontheassumptionof150consentingSoldiers percompany.Amoredetail edsamplesizeestimation andpoweranalysiswaspublishedwithourtrialprotocol [14].DataanalysisTherewerenoplannedinterimanalysesorstopping rulesforthePOLMtrial[14].Allstatisticalanalyses wereperformedusingtheSASsoftware,version9(SAS InstituteInc,Cary,NorthCarolina,UnitedStates,1996). Demographicandbaselinelevelsofclinicalvariables werecomparedamongthefourinterventiongroups usinganalysisofvariance(ANOVA)formeansandchisquaretestsforproportions.Variablesthatdiffered betweenthefourinterventiongroupswereconsidered inthefinalanalyses,inadditiontopre-specifiedcovariatesofgenderandage. TheincidenceofLBPresultingintheseekingof healthcaredatawasanalyze dwithageneralizedlinear mixedmodelandtheresponsevariablewasthenumber ofmonthsinwhichaSoldierreportedLBP.Becausethis wasaclusterrandomizedtrialweconsideredcompany asarandomeffect.Theplannedfixedeffectsweretreatmentgroup,ageandgender,aswellasanyvariables thatdifferedamongthefourinterventiongroupsafter randomization.SurvivaltimetothefirstdayofLBPwas investigatedwithaCoxproportionalhazardsmodeland log-ranktesttoinvestigatetreatmenteffects.The responsevariablewastimetofirstdayinwhichtreatmentforLBPwasidentifiedintheM2databaseusingGeorge etal BMCMedicine 2011, 9 :128 http://www.biomedcentral.com/1741-7015/9/128 Page4of11

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thedateofenrollmentasthestartingpoint.Thepredictorvariablesforthesurvivalanalysiswerethesamevariablesincludedinthegeneralizedlinearmixedmodels.ResultsFigure1providesinformationonstudyenrollment, assignmenttothefourinterventionarms,participation, follow-up,andanalysisforallstagesofthePOLMtrial [15].Therewerenoreportedadverseeventsfortheeducationandexerciseprograms.Table2providesbaseline characteristicsforeachofth erandomlyassignedexerciseandeducationcombinations.Baselinedifferences acrossindividualsinthefourcompanieswerefoundin age,education,income,activedutystatusandtimein thearmy(Table2).Thesedifferenceswerecontrolled forinsubsequentanalysesand,therefore,alldatafrom theregressionmodelsarepresentedasadjusted estimates.Lowbackpainincidenceresultinginseekingofhealth careOvertwoyearsthenumberofSoldierscapturedinthe M2databasewas4,147/4,325(95.9%),and,ofthose,706 (17.0%)hadLBPresultinginseekingofhealthcare. LowerincidenceofLBPresul tedfromthecombination ofanyexercisewitheducation(CSEP+PSEPandTEP +PSEP).Table3showsLBPincidencebypercentage forall20individualcompanies(coefficientofintraclustercorrelationof0.0053).Table3alsoshowstheincidencedatabythefourrandomlyassignedintervention groupsonwhichtheprimaryanalyseswerecompleted. Theanalysesofthefourinterventiongroupssuggested apatternthatallowedformoreefficientcommunication ofresultsbycollapsingtheinterventiongroupsinto thosereceivinganycorestabilization(CSEP-yesorno) oranypsychosocialeducation(PSEP-yesorno).There werenodifferencesbetweentheTEP+PSEPandCSEP +PSEPgroups,butchi-squaretestindicatedthatreceivingthePSEPprogramwithanyexerciseprogramwas protectiveofLBPincidence(Chi-square=5.56, P = 0.018;and5.05, P =0.025whenadjustedforintracluster correlation)incomparisontothosenotreceivingPSEP. Furthermore,afteradjustingfordemographicandbaselinelevelsofclinicalvariables,theprotectivepooled effectofanyPSEPwasestimatedat3.3%(95%CI:1.1to 5.5%)decreasedLBPincidenceovertwoyears( P = 0.007).Thiseffectcorrespondstonumbersneededto treat(NNT)of30(95%CI=18.2to90.9). ResultsfromthegeneralizedlinearmixedmodelindicatedthatSoldiersinthecombinedexerciseandpsychosocialeducationgroups(CSEP+PSEPandTEP+ PSEP)weresimilar,butexperiencedanaverageof0.49 fewermonthswithincidenceofLBP(95%CI:0.003to 0.983, P =0.048)incomparisontothosenotreceiving Initial Entry Training (IET), Low Back Pain (LBP) Core Stabilization Exercise Program (CSEP), Traditional Exercise Program (TEP), and Psychosocial education (PSEP) c = number of com p anies, m = median of # of soldiers p er com p an y r = min max, n = total number of soldiers. Soldiers in IET (n=7616) Met Inclusion/Exclusion Criteria (n=5875) TEP (c=5, m=248, r=191-297, n=1216) Ineligible (n=1741) Elected not to participate (n=1550) Baseline Randomization ( c=20 m=234 r=67-297 n=4325 ) Outside age range (n=468) Previous history of LBP (n=942) Current treatment for LBP (n=110) Not participating in unit training (n=81) History pelvis or hip fracture (n=78) Currently pregnant (n=2) Transferred from another Company (n=39) Other: (n=21) TEP + PSEP (c=5, m=229, r=85272, n=952) CSEP (c=5, m=250, r=67271, n=1096) CSEP + PSEP (c=5, m=201, r=183-267, n=1061) 2-year utilization follow-up n=1161 2-year utilization follow-up n=909 2-year utilization follow-up n=1041 2-year utilization follow-up n=1036 2-year analysis (n=1212) Excluded (n=4) 2-year analysis (n=945) Excluded (n=7) 2-year analysis (n=1089) Excluded (n=7) 2-year analysis (n=1050) Excluded (n=11) 21 Soldiers with missing main demographics variables and 8 soldiers with other duty status were excluded from analysis. Figure1 Flowdiagramforpatientrecruitmentandrandomization George etal BMCMedicine 2011, 9 :128 http://www.biomedcentral.com/1741-7015/9/128 Page5of11

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PSEP.Survivalanalysisonthetimetothefirstdayof LBPdemonstratedasimilarpattern(Figure2),where thepreventativeeffectofanypsychosocialeducation wasobserved(hazardratio=0.90;Log-Ranktest, P = 0.021).DiscussionThePOLMclusterrandomizedtrialisthefirstlargescale trialtotestthepurportedprimarypreventioneffectsof corestabilization,aloneandincombinationwithpsychosocialeducation,forLBP.Trialresultssuggestnobenefit ofcorestabilizationexercisesforpreventingLBPincidence resultingintheseekingofhealthcareincomparisonto traditionallumbarexercises.Incontrast,abriefpsychosocialeducationprogramincombinationwitheitherofthe exerciseprogramsresultedinlowertwo-yearincidenceof healthcare-seekingforLBP.Theseresultshavepotential importanceforprimarypreventionstrategiesforSoldiers Table2ComparisonofbaselinecharacteristicsacrosstheinterventiongroupsVariable Label OverallTEPTEP+PSEPCSEPCSEP+PSEP P -Value N=4,325N=1,216N=952N=1,096N=1,061 Innatecharacteristics AAge 22.04.221.64.122.64.521.84.022.14.3<0.0001 Gender Male 3,082870(71.7%)689(72.5%)758(69.5%)765(72.7%)0.335 Female 1,226344(28.3%)262(27.5%)333(30.5%)287(27.3%) Race BlackorAfrica 420104(8.6%)88(9.3%)114(10.4%)114(10.8%)0.236 Hispanic 426128(10.5%)97(10.3%)115(10.5%)86(8.1%) WhiteorCaucas3,190897(73.8%)711(75.2%)797(72.8%)785(74.1%) Other 27986(7.1%)50(5.3%)69(6.3%)74(7.0%) Education Highschoolorlower1,935600(49.3%)409(43.0%)484(44.2%)442(41.7%)0.0038 Somecollege1,998504(41.4%)463(48.6%)506(46.2%)525(49.5%) Collegeorhigher391112(9.2%)80(8.4%)105(9.6%)94(8.9%) Income Lessthan$20,0002,125620(51.2%)418(44.0%)583(53.3%)504(47.7%)0.0001 Greaterthan$20,0002,188592(48.8%)532(56.0%)511(46.7%)553(52.3%) ActiveDuty Active 2,532725(59.6%)504(52.9%)737(67.4%)566(53.4%)<0.0001 Reserve 1,782491(40.4%)446(46.8%)356(32.5%)489(46.1%) Other 8 2(0.2%)1(0.1%)5(0.5%) TimeInArmy <5months 2,691768(63.2%)566(59.5%)737(67.4%)620(58.5%)<0.0001 5monthsto1year969276(22.7%)198(20.8%)222(20.3%)273(25.8%) Morethan1year661172(14.1%)188(19.7%)134(12.3%)167(15.8%) Height 68.33.968.43.768.43.868.14.068.44.00.340 Weight 164.827.7164.826.7165.728.2163.827.9165.228.00.426 BMI 24.83.124.73.024.83.324.73.224.73.20.807 Psychological BDITotal 6.46.66.56.96.46.76.56.56.36.20.843 FPQTotal 18.15.917.85.918.25.918.06.118.25.60.317 BBQTotal 43.47.143.37.243.16.944.06.843.27.20.010 STAI 36.09.136.29.535.89.135.79.036.39.00.337 Baselinehealthstatusandphysicalactivity SF12PCS 53.45.253.75.053.55.053.45.353.15.20.041 SF12MCS 49.28.649.28.749.18.749.28.549.08.50.938 SmokePriortoArmy Yes 1,552442(36.3%)354(37.2%)374(34.2%)382(36.0%)0.534 No 2,771774(63.7%)598(62.8%)720(65.8%)679(64.0%) ExerciseRoutinely Yes 2,220627(51.6%)474(49.8%)560(51.2%)559(52.7%)0.647 No 2,102589(48.4%)477(50.2%)534(48.8%)502(47.3%) Attention/RelationalEffect PhysicalExam No 3,9511,128(92.8%)855(89.8%)1,005(91.7%)963(90.8%)0.087 Yes 37488(7.2%)97(10.2%)91(8.3%)98(9.2%)BBQ,BackBeliefsQuestionnaire;BDI,BeckDepressionInventory;BMI,bodymassindex;CSEP,corestabilizationexerciseprogram;FPQ,FearofPainQuestionnaire (9items);PSEP,psychosocialeducationprogram;SF12MCS,MentalComponentSummaryScorefromtheShortFormMedicalSurvey(12items);SF12PCS, PhysicalComponentSummaryScorefromtheShortFormMedicalSurvey(12items);STAI,StateTraitAnxietyInventory(stateportiononly);TEP,traditional exerciseprogramGeorge etal BMCMedicine 2011, 9 :128 http://www.biomedcentral.com/1741-7015/9/128 Page6of11

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inthemilitarygiventhehighratesofevacuationdueto musculoskeletalpainandinjuriesthatadverselyaffects Soldierpreparation[1,2]. TheoveralldecreaseinLBPfrombriefpsychosocial educationmightbeperceivedassmall,butthe3.3% decreaserepresentedtheabsoluteriskreduction, whereastherelativeriskreductionwasapproximately 17%.Furthermore,seekinghealthcareforLBPisvery common[30,31],soevensmalldecreasesinLBPincidencecouldpotentiallyle ssentheburdenonahealth caresystem.Thepsychosoc ialeducationprogramwas administeredinasingle, low-costsession.Thereis potentialforsimilareducationprogramstobedonein anefficientmanner,suchthatwhenappliedtopopulationstheyyieldincrementaldecreasesinLBPincidence. Preventionofhealthcareseekingbyeducationseems especiallyrelevantwhenincreasedusageandexpendituresofhealthcareforLBPhavenotresultedinobvious improvementsinpopulationoutcomes[32,33]. Theprimarylimitationofthecurrentstudyisthat theseresultsmayhavelimiteddirectapplicationtocivilianpopulationsduetotrialimplementationinamilitarysetting.Forexample,analternateexplanationfor thenulleffectsofcorestabilizationexercisecouldbe thatSoldiersinthistrialwereathighlevelsofgeneral fitnessandnotlikelytobenefitfromadditionalexercise. Anotherlimitationisthatthecurrentstudydidnot includeatruecontrolconditionsowecannotcomment ontheabsoluteeffectsoftheexerciseprograms.Wedid havearandomlyselectedgroupofSoldierswhoreceived additionalattentionfromaphysicalexaminationand ultrasoundimaging[14].Therewerenodifferencesin LBPincidencefortheseSoldiers,suggestingnogeneral attentioneffectinthistrial(Table2). Thedecisiontoshiftfromaself-reportdefinitionof LBPincidencetoadefinitionbasedonseekingofhealth careisanotherlimitationtoconsider.Aspreviously noted,thisdecisionwasmadebeforetheplannedendof Table3LBPratebycompanybasedonutilizationdataTrainingGroupCompanyNNumber(%)ofSoldierswithLBPincidenceresultinginseekingofhealthcare TEP 119130(15.7%) 2 252 41(16.3%) 3 228 37(16.2%) 4 297 59(19.9%) 5 248 46(18.5%) All 1216 213(17.5%) TEP+PSEP 1 272 36(13.2%) 2 85 12(14.1%) 3 229 39(17.0%) 4 103 15(14.6%) 5 263 30(11.4%) All 952 132(13.9%) CSEP 1 250 44(17.6%) 2 271 33(12.2%) 3 239 50(20.9%) 4 269 55(20.4%) 5 67 11(16.4%) All 1096 193(17.6%) CSEP+PSEP 1 217 37(17.1%) 2 183 26(14.2%) 3 193 29(15.0%) 4 201 35(17.4%) 5 267 41(15.4%) All 1061 168(15.8%) CSEP Yes 2157 361(16.7%) No 2168 345(15.9%) PSEP Yes 2013 300(14.9%) No 2312 406(17.6%)Datapresentedinthetableareunadjusted.Totalinterventiongroupsareinbold.Theintraclustercorrelationcoefficient(ICC)is0.0053.ForthetestofequalLBP rateacrossinterventiongroups,comparingTEPYesvsNo,andcomparingPSEPYesvsNo,theChi-Squarevaluesequalto6.99,0.54,and5.56;with corresponding P -valuesof0.0722,0.4641and0.0183,respectively.AdjustingforICC,theChi-squarevaluesreduceto6.35,0.49,and5.05;withcorresponding P valuesof0.0957,0.482and0.0246,respectivelyGeorge etal BMCMedicine 2011, 9 :128 http://www.biomedcentral.com/1741-7015/9/128 Page7of11

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thestudy,wasnotbasedonanyinterimanalyses,and wasnotaprocessofchoosingoneoutcomefrommultiplepotentialoutcomes.However,theendresultofthis decisionisthatourincidencemeasureofLBPresulting intheseekingofhealthcarewasnotbasedonselfreportofsymptomsandhadcloseto96%follow-upat twoyears.Thereisthepotentialthatthesefindings couldunderestimatetheeffectoftheseinterventionson mildLBPepisodesthatdidnotnecessitatehealthcare andalsowewerenotabletofurtherdescribetheutilizationofhealthcare.Forexample,wecouldnot distinguishbetweenservicesthatwereprovidedforcare duringtheepisode.Overall,however,wefeeltheshiftto aLBPincidencedefinitionthataccountedforhealth careseekingprovidedanunintendedpositivedimension tothePOLMtrial.Theindividualdifferencesafterclusterrandomizationcouldhaveledtosystematiceffects basedonthecompany,ratherthantheassignededucationprogram.However,wehadlowintraclustercorrelationssuggestingindependencebetweenclustersand outcomemeasure.Baselineclusterdifferenceswerealso smallinmagnitude(Table2)andweaccountedfor 0 200 400 600 800 0 5 10 15 20 Da y s Since EnrollmentPercent o f S oldiers with LBP TEP TEP+PSEP CSEP CSEP+PSEP Figure2 PercentofSoldiersreportingincidenceoflowbackpain(unadjusteddata) George etal BMCMedicine 2011, 9 :128 http://www.biomedcentral.com/1741-7015/9/128 Page8of11

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companyasarandomeffectinallanalyses.Therefore, weareconfidentthatindividualclustereffectsarefully accountedforwhenpresentingtheresults. AnotherweaknessofthisstudyisthatSoldiersdid additionalsit-upstoprepareforfitnesstestingandthis trainingcouldhaveadverselyaffectedthecorestabilizationexercise[12,16].However,therateofadditionalsitupswasequivalentacrossthefourgroupssoanyadditiveeffectsofextratrainingwouldlikelyhavehadan equalimpactonoutcomes.Wetookapragmatic approachtoexercisedosinganditcouldbearguedthat dosageparametersforcorestabilizationwerenotsufficienttogenerateapreventativeeffect.However, ourdosingparameterswereconsistentwithexpert recommendationsforcorestabilizationexercise[37]. Furthermore,wedidnotfacilitateortrackexerciseperformanceofanykindafterthe12-weektrainingperiod andthatisanotherweaknesstoconsider.Finally,wedid notdetermineiftheLBPepisoderesultedinmedical board(disability)orevacuationforSoldierswithLBP andthisoutcomemeasurewouldbeofimportancefor futurepreventionstudies. AstrengthofthePOLMtrialisthatwerecruiteda largeinceptioncohortofSoldiersnotpreviouslyexperiencingLBP.Thisfactorwashighlightedasaresearch priorityforLBPpreventionstudiesintheEuropean Guidelines[6]andtheapplicationofpotentiallypreventativeinterventionsbefor edeploymentwasconsistent withrecentmilitaryrecommendations[1,2].Two-year follow-upofallLBPepisodesisanadditionalstrength ofthePOLMtrial.Finally,useofahealthcareutilizationdatabasetodefineLBPincidenceisastrengthof thestudybecauseofincreasedutilizationtrendsforLBP [30-33]andconcernswithusingself-reportdefinitions inmilitarysamples[34].Readersshouldrealize,however,thatthiswasaspecificwayofdeterminingLBP incidenceandtheresultsofthePOLMtrialmaynot generalizetootherwaysofdeterminingLBPincidence (forexample,surveymethods). ExerciseandeducationforprimarypreventionofLBP hasreceivedmixedsupportfromtheEuropeanGuidelines[6]andsystematicreviewsofworkplaceinterventions[5,38].Individualtrialshavesuggestedsometypes ofexercisemaybepreventativeofLBPwhencompared tonointervention[39],butsimilareffectshavebeen reportedwhenexercisewascomparedtopatienteducation[40].InthePOLMtrial,twodifferentexercise approachestargetingtrunkmusculaturewerecompared andtherewasnobenefitfromperformingspecificcore stabilizationaswehadhypothesized.ThePOLMtrial findingsare,therefore,consistentwithGuidelinerecommendations[6]thatindicatenoaddedbenefitofaparticularfocusedexerciseapproachforpreventionofLBP. FuturestudiesinvestigatingprimarypreventionofLBP mayconsiderdifferentmeth odsfordeliveringexercise, suchastailoredindividualizedapproachesthathave demonstratedefficacyfortreatmentofpatientswith chronicLBP[41]. ThePOLMtrialdidprovidedataindicatingthatpsychosocialeducationbasedontheFAMhaspotential valuefordecreasingincide nceofLBPresultinginthe seekingofhealthcare.SimilarpositiveeffectsforLBPof psychosocialpatienteducationbasedontheFAMhave beenreportedinquasi-experimentalstudiesinAustralia [42]andFrance[21].Althoughthereissomeevidence thatFAMfactorshavelimitedprognosticvalueinacute stagesofLBP[43],theseeducationalstudiesprovideevidenceofbenefiteitherbeforepain[42]orintheacute stageofLBP[21].Whatthepreviouslyreportededucationstudiesdonotoftenaddressisprocessesthatmay accountforthebenefit.InthecaseofthePOLMtrial, wedidperformaplannedpreliminaryanalysistoinvestigatetheshorttermefficacyofourpsychosocialeducationprogramforaproximalendpointthatoccurred aftertheir12-weektrainingbutbeforedeployment[13]. Inthispreliminaryanalysis,Soldiersreceivingthepsychosocialeducationprogramreportedimprovedbeliefs relatedtotheinevitableconsequencesofLBPasmeasuredbytheBackBeliefsQuestionnaire[13].Incontrast,Soldiersnotreceivingthepsychosocialeducation programhadaslightworseningoftheirbeliefsofLBP. It,therefore,couldbeassertedthatapositiveshiftin beliefsaboutLBPwhileanindividualispain-freemay resultindecreasedlikelihoodtoseekhealthcarewhen LBPwaslaterexperiencedduringmilitarydeployment. Thisearlierstudyprovidesdatatosupportaprocessto explaintheprimaryfindingsofthePOLMtrial,butwe didnotcollectLBPbeliefswiththeBackBeliefsQuestionnaireduringtheepisodeofLBP,sowelackthelong termdatathatwoulddirectlyvalidatethisprocess. Thereareunansweredquestionsandfutureresearch directionstoconsiderfollowingthePOLMtrial.Future studiescouldconsidertestingthepreventativecapability ofcorestabilizationindifferentpopulationswithlower overallfitnesslevels.Also,determiningifthepsychosocialeducationprogramtranslatestodifferentcivilian settingswouldbeofparticularinterestasthereare othertrialsthathavedemonstratedpositiveshiftsin LBPbeliefsforschoolagechildren[44]andoldernursinghomeresidents[45].Thisparticularpsychosocial educationprogramusedinthePOLMtrialhaspotential togeneratecost-savingsfo rthoseseekinghealthcare forLBP,especiallyifitpreventsexposuretoexpensive interventionsthathavequestionableefficacy[32]. Finally,weusedwhatcouldbeconsideredasmalldose ofpsychosocialeducationwithnoreinforcementafter theinitialsession[13].DifferentdosagesandreinforcementstrategiesfortheeducationprogramcouldbeGeorge etal BMCMedicine 2011, 9 :128 http://www.biomedcentral.com/1741-7015/9/128 Page9of11

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exploredinfuturestudiest odetermineiflargereffect sizesareobservedforprimarypreventionofLBP.ConclusionsTheEuropeanGuidelinesforPreventionofLowBack Pain[6]indicatedahighpriorityforrigorousrandomizedclinicaltrialsthatinvestigateprimaryprevention ofLBP.CompletionofthePOLMtrialmeetsthispriorityandhasprovidedadditionaldataforthoseinterested inprimarypreventionofLBP .Specifically,ourresults suggestthatexerciseprogramsthattargetcorelumbar musculaturemayoffernoadditionalpreventativebenefit whencomparedtotraditionallumbarexerciseprograms. Also,briefpsychosocialeducationmaybeanimportant adjuncttoexerciseprogramsastheymaypreventthe seekingofhealthcarewhenexperiencingLBP.These arenovelfindingsand,sincethisstudywasdoneina militarysetting,futureresearchisnecessarytodeterminewhethertheseeducationprogramscouldbeimplementedincivilianpopulationswithsimilarefficacy.In addition,futurestudiesshouldconsiderthecost-benefit ofeducationprogramsthatreduceLBPincidenceresultingintheseekingofhealthcare.Abbreviations CONSORT:ConsolidatedStandardsofReportingTrials;CSEP:core stabilizationexerciseprogram;FAM:Fear-AvoidanceModelof MusculoskeletalPain;ICD:InternationalClassificationofDiseases;LBP:low backpain;MHS:MilitaryHealthSystem;NNT:numbersneededtotreat; POLM:PreventionofLowBackPainintheMilitary;PSEP:psychosocial educationprogram;TEP:traditionalexerciseprogram Acknowledgements Theviewsexpressedinthismaterialarethoseoftheauthors,anddonot reflecttheofficialpolicyorpositionoftheU.S.Government,Departmentof Defense,U.S.Army,orU.S.AirForce. ThePOLMclusterrandomizedtrialwassupportedbythepeer-review medicalresearchprogramoftheDepartmentofDefense(PR054098).All authorswereindependentfromthisfundingprogramandthefunding programplayednoroleinthedesignandconductofthestudy;collection, management,analysisandinterpretationofthedata;andpreparation, revieworapprovalofthemanuscript.Allcontributingauthorshadaccessto allstudydataandtakefinalresponsibilityforpapersubmission. PublicationofthisarticlewasfundedinpartbytheUniversityofFlorida Open-AccessPublishingFund.Allauthorshadfullaccesstoallofthedata reportedinthestudyandcantakeresponsibilityfordataintegrityand accuracy. Theauthorsthanktheleadership,cadreandstudentsfromthe232ndMedicalBattalionandthe32ndMedicalBrigadefortheirsupportandstudy participation.ThankstoMAJScottGreggandDavidH.Montplaisir,Jr.for compilingthehealthcareutilizationdata,ChristopherBarnes,YangLi,and ErikHenricksonforcreationandmanagementofthewebsiteanddatabase andJessicaNeffforassistancewithdataentryandconfirmation.Wealso thankYunfengDaiforassistancewithstatisticalanalyses,Donna Cunninghamforheradministrativeassistance,andvariousphysicaltherapy studentsfromtheU.S.Army-BaylorUniversity,UniversityofTexasHealth ScienceCenteratSanAntonio,TexasStateUniversity,UniversityofPuget Sound,EastTennesseeStateUniversity,andUniversityofColoradoatDenver andHealthScienceCenter. Authordetails1DepartmentofPhysicalTherapy,POBox100154,UniversityofFlorida, Gainesville,FL,32610USA.2DepartmentofPhysicalTherapy(MSGS/SGCUY), 81stMedicalGroup,KeeslerAirForceBase,Biloxi,MS,39534USA.3USArmyBaylorUniversityDoctoralPrograminPhysicalTherapy(MCCS-HMT),Army MedicalDepartmentCenterandSchool,3151ScottRd.,Rm.2307,FortSam Houston,TX78234USA.4USArmyPublicHealthCommandRegion-South, FortSamHouston,TX78234USA.5DepartmentofBiostatistics,POBox 117450,UniversityofFlorida,Gainesville,FL32611USA.6Departmentof ClinicalandHealthPsychology,POBox100165,Health,UniversityofFlorida, Gainesville,FL32610USA.7CenterforPainResearchandBehavioralHealth, POBox100165,UniversityofFlorida,Gainesville,FL,32610USA. Authors contributions SZG,JDC,DST,SSWandMERwereresponsiblefortheinitialconceptionof theresearchquestion,securingfunding,supervisingtheprotocol,andfinal manuscriptpreparation.SSWwasprimarilyresponsiblefordataanalysis, interpretationandreporting,whileSZG,JDC,DSTandMERassistedwith interpretationandreporting.ACWandJLDwereresponsiblefor implementingthestudyprotocol.Allauthorsread,editedandapprovedthe finalversionofthemanuscript. Competinginterests Theauthorshavenocompetingintereststodeclarewithsubmissionofthis manuscript.AllauthorshavecompletedtheUnifiedCompetingInterest formathttp://www.icmje.org/coi_disclosure.pdfandtheseformsare availableonrequestfromthecorrespondingauthor.Allauthorsreceived financialsupportfromtheDepartmentofDefensetocompletethe submittedwork;havenofinancialrelationshipswithanyorganizationsthat mighthaveaninterestinthesubmittedworkintheprevious3years;and havenootherrelationshipsoractivitiesthatcouldappeartohave influencedthesubmittedwork. 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Submit your next manuscript to BioMed Central and take full advantage of: Convenient online submission Thorough peer review No space constraints or color gure charges Immediate publication on acceptance Inclusion in PubMed, CAS, Scopus and Google Scholar Research which is freely available for redistribution Submit your manuscript at www.biomedcentral.com/submit George etal BMCMedicine 2011, 9 :128 http://www.biomedcentral.com/1741-7015/9/128 Page11of11