fri study

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Functional Rating Index: Literature review

Ronald J. Feise1, J. Michael Menke2

1 Institute of Evidence-Based Chiropractic, Fort Collins, CO, U.S.A.2 Departments of Psychology and Pharmacoeconomics, University of Arizona, Tucson, AZ, U.S.A.

Source of support: Institute of Evidence-Based Chiropractic

Summary

In1999,anewself-reportoutcomemeasure,theFunctionalRatingIndex(FRI),wasdevelopedandtested.Thismeasuredemonstratedreasonablereliability,validityandresponsiveness.Sincethepublicationoftheoriginaltesting,numerousindependentresearchteamshaveexaminedthepsy-chometricqualitiesoftheFRIandpublishedtheirfindings.TheaimofthisstudyistoreviewthepsychometricpropertiesoftheFRIasreportedbypublishedstudies.ResearchersindependentlysearchedtheliteratureforrelevantstudiesusingMEDLINEandIndextoChiropracticLiteraturefromJanuary2001toAugust2009.Descriptiveandoutcomedatawasextractedusingstandardizedforms.ThepsychometricpropertiesoftheFRIwereanalyzedwithestablishedcriteriaandcom-paredhead-to-headwithotheroutcomemeasures.Thesearchyieldedtenstudiesthatprovidedpsychometricdata.Reliability:Test-retest:IntraclasscorrelationcoefficientandCronbachsalphaweregood,andFRIisequivalenttotheothermeasures.Validity:theFRIhasgoodconvergentva-liditywithpainandfunctionself-reportscalesandaweakercorrelationwithitemsthatmeasuredif-ferentconstructs.Responsiveness:FRIwassimilartothecomparativemeasuresforstandardizedre-sponsemean,effectsizeandreceiveroperatingcurvestatistics.Patient acceptability:timerequiredbythepatientandstaffaveraged78secondsperadministration,andtherewerefewmissingrespons-es.TheFRIdemonstratesfavorablemeasurementpropertiesofreliability,validityandresponsive-ness.Itprovidesanalternativetootherself-reportmeasures,becauseitisquickerforapatienttocompleteandcanbeusedforpatientswithneckandbackpain.

key words: back pain neck pain reliability validity responsiveness practicality treatment outcome outcome assessment (health care)

Full-text PDF: http://www.medscimonit.com/fulltxt.php?ICID=878347

Word count: 3063 Tables: 5 Figures: References: 73

Authors address: Ronald J. Feise, Institute of Evidence-Based Chiropractic, 6252 Rookery Road, Fort Collins, CO 80528, U.S.A., e-mail: [email protected]

Received: 2009.10.13Accepted: 2009.12.01Published: 2010.02.01

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Review ArticleWWW.MEDSCIMONIT.COM Med Sci Monit, 2010; 16(2): RA25-36

PMID: 20110929

RA

Current Contents/Clinical Medicine IF(2008)=1.514 Index Medicus/MEDLINE EMBASE/Excerpta Medica Chemical Abstracts Index Copernicus

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Background

Patientself-reportmeasuresarerecognizedas importanttoolsforassessingpatientoutcomes.Inpatientswithspi-nalconditions,itisimportantforthephysiciantoquick-lyassesstheeverydayfunctioningandsymptomsofthepa-tientandtohaveamethodofquantifyingthoseitems[1,2].Generally,disease-specificinstrumentsareconsideredsu-perior formeasurements indisease-specificpopulationswhencomparedtogenericinstruments,becausetheyaremoreresponsive[3,4].

Researchersandpractitionersare facedwithavarietyofoptionswhenchoosingaself-report instrument toassesspatientswithspinalconditions.Selectingameasureisnotstraightforward.Practitionersandresearchersmustfirstdeterminethetypesofmeasurestobeassessed.Theymustthenevaluatethepsychometricqualitiesofthepossiblein-struments.Severalresearchershavesuggestedthatacom-prehensivepsychometricassessmentofoutcomemeasuresisnecessaryinordertocarefullyselectthemostappropri-atemeasure[57].Suchanassessmentshouldinclude,ataminimum,analysisofreliability,validity,responsiveness,practicality,anddistributionofscores[57].

In1999,anewself-reportoutcomemeasure,theFunctionalRatingIndex(FRI),wasdevelopedand tested[8].Thismeasuredemonstratedgoodreliability, validityandre-sponsiveness.Moreover, this instrumentreducedthead-ministrativeburdencommonwithotherself-reportspinaloutcomemeasures.Sincethepublicationoftheoriginaltesting,numerousindependentresearchteamshaveexam-inedthepsychometricqualitiesoftheFRIandpublishedtheirfindings.Twopreviousreviewsformedconclusionsbe-foreadditionaltestingswerepublished[9,10].Noresearchteamhasreviewedthefindingsfromthesemorerecentin-dependentstudies.TheaimofthisstudyistoreviewthepsychometricpropertiesoftheFRIasreportedbyallpub-lishedstudiestodate.

Material and Methods

Study criteria

Thefollowingcriteriawereusedinconsideringstudiesforthisreview:

Inclusion criteria:1.ArticlesthattestedthepsychometricqualitiesofthetheFRI.2.ArticlesthatusedtheFRIasanoutcomemeasure.3.ArticlesthatusedtheFRIasaprognosticvariable.4.ArticlesthattranslatedFRIintoanotherlanguage.5.ArticleswritteninEnglish.

Exclusion criteria:1.Articlesfromeditorialsandletters.

Search strategy

TheauthorssearchedtheliteratureforrelevantstudiesusingMEDLINEand Index toChiropracticLiteraturefromJanuary2001toAugust2009.Theyaccessedrelat-edarticlesinrelevantMEDLINE(PubMed)papersandretrievedarticlescitedinthebibliographiesofrelevant

papers.Twoauthors conducted the literature searchesindependently.

Data extraction

Twonon-blindedauthorsindependentlyextracteddescrip-tiveandoutcomedatausingstandardizedforms.Basedon full text reading, theauthors then systematically re-viewedeveryarticleforthefollowingcharacteristics:au-thorandyearofpublication,FRIlanguage,samplesize,patientpopulation,baselinedataandpsychometricprop-erties.Thepsychometricpropertiesandcriteriaarede-finedinTable1.

Data analysis

Adescriptiveanalysisofthedatawasappliedusingthresh-olds foracceptability asdefined inTable1.Other in-strumentswerecomparedtotheFRIwithincountrylan-guageby intra-class correlationcoefficients (ICC)andPearsonproduct-momentcorrelationcoefficients.Within-instrumentreliabilitieswereestimatedbyCronbachsal-pha.Parameterestimateswere interpretedbystandardselucidatedinTable1.

results

Thesearchyielded26citationsthatmettheinclusioncri-teria.Therewasnodisagreementbetweenthereviewersre-gardingtheselectionofpapersordataextraction.Includedstudiesweresortedintothefollowinggroupings:psycho-metricstudies,prognosisstudiesandclinicalstudiesthatusedFRIasanoutcomemeasure.

Tenstudiesprovidedpsychometricdata[8,2735], twogaveprediction information[36,37],and fourteenem-ployedFRIasanoutcomemeasureinaclinicalstudy[3851].FRIhasbeentranslatedintothreelanguages:Korean,Brazilian-PortugueseandTurkish[28,31,33].Somestud-iesincludedinthisreview,althoughpublishedinEnglish,wereconductedusingforeignlanguagetranslationsoftheFRIinstrument.Throughoutthisresultssection,thestud-iesconductedusingtheoriginalEnglishversionoftheFRIarereferredtoasEnglishversionstudies.

Content validity

TheFRIisaninstrumentspecificallydesignedtoquanti-tativelymeasurethesubjectiveperceptionoffunctionandpainofthespinalmusculoskeletalsysteminaclinicalenvi-ronment[8].TheFRIemphasizesfunctionwhileconcur-rentlymeasuringthepatientsopinion,attitudeandself-ratingofdisability.TheFRIquestionnairemeasures thepatientsperceptionoftheseitemsatthetimethepatientiscompletingthequestionnaire(now).

TheFRIsscaleitemsaremodeledfromapooloftwoinstru-ments:OswestryDisabilityIndex(ODI)andNeckDisabilityIndex(NDI),bothofwhichhavebeenwidelyresearchedandvalidated[52,53].Overall,noinstrumentsareknowntobesignificantlymoreadvantageous thanODIfor thelowbackorNDIfortheneck.(Note:Dr.Vernon,thede-veloperoftheNDI,servedasaconsultantinthedevelop-mentoftheFRI.)

Review Article Med Sci Monit, 2010; 16(2): RA25-36

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Feise,theauthoroftheFRI,hypothesizedbasedonover30yearsofclinicalexperiencewhichofthescaleitemsfromtheODIandNDIwouldbecomprehensivewithoutbeingredundantorirrelevant.Theaimwastoselectscaleitemsthatwouldmeasureneckandbackconditionswithequalresponsivenesswithoutaffectingotherpsychometricquali-ties.Toensurethatthescaleitemsselectedrepresentedrel-evantdomains,doctorsin12chiropracticclinicssuppliedinputbasedonfeedbackfromtheirpatients(e.g.,recom-mendeddeletingand/oraddingitems)overapilotperi-odof1year.Byanalyzingalpha(ifitemdeleted),CostademonstratedthatallitemsfromtheFRIwererelevantandcontributedtothesameconstruct[31,32].

OneoftheaimsincreatingtheFRIwastoimproveontheresponsescalesofODIandNDI(e.g.,reduceadministra-tiveburdenwithoutsacrificingresponsivenessorreliabil-ity).Thus,a5-pointscalewasselected,becauseitwastheeasiesttocomplete,hadtheleastfrequentitemomission,

andwas themostusefulwhenmeasuringhealth status[5457].Five-pointresponsescaleswerecreatedforeachitemof theFRI,andtheseresponsescalesweresubmit-tedtochiropractorsandtheirpatientsforinput.Thesug-gestionsofthesestakeholderswereincorporatedintothemeasureinanefforttorefinerelevance,readabilityandcomprehension.

Scoresforthe10itemsoftheFRImaybeusedindividuallytoprofilespecificaspectsofasubjectsdysfunctionandpain,ortheymaybetotaledtoprovideanoverallassessment.Ifasubjectmarksbetweentworesponsenumbers,thenumbersshouldbeaveragedforthatresponse.Theindexscoreisachievedbysimplysumminguptheequallyweightedscores,multiplyingby2.5,andstatingthisscoreasapercent.Therangeofscoresis0%(nodisability)to100%(severedis-ability).Thehigherthenumber,thehighertheperceiveddysfunctionandpain;thelowerthenumber,thelowertheperceiveddysfunctionandpain.

Property Description

Content validityContent validity refers to the extent to which items in the questionnaire represent the facets of a concept of interest [11]. Characteristics that should be included are a description of the measurement aim, the target population of concern, the concepts that are being measured and the item selection process [12].

Coefficient of stability

The coefficient of stability is primarily measured by test-retest [13]. Intraclass correlation coefficient (ICC) and Cohen's kappa can be used to measure stability. Reliability coefficients below 0.50 indicate poor reliability, 0.5075 moderate reliability, and above 0.75 good reliability [14]. Although reliability scores of 0.90 or more are considered optimal for use in clinical decision making [12,15], some researchers regard scores of 0.70 as acceptable for clinical use [16].

Internal consistencyThe coefficient of internal consistency is mainly assessed with Cronbach's alpha [17]. Cronbach coefficients exceeding 0.70 generally are regarded as acceptable, those exceeding 0.80 as good, and those exceeding 0.90 as excellent [18], but they should not exceed 0.95 [12].

Construct validity

Construct validity is best described as the orderliness of findings: correlating well with measures of the same construct and poorly with measures of different constructs, and discriminating between cohorts known to differ. Following are the generally accepted rankings for construct validity coefficients: 0.25 none to little; 0.25.50 fair; 0.50.75 moderate to good; >0.75 very good to excellent [19].

Responsiveness

Responsiveness may be broadly defined as the ability of a measure to detect clinically important change [20]. A number of strategies have been suggested for quantifying responsiveness of evaluative questionnaires, but there is currently no consensus on the most appropriate method [21,22]. Internal responsiveness can be determined by calculating the effect size (ES) and standardized response mean (SRM). Higher scores are preferred [12]. External responsiveness can be calculated with the perceived recovery scale as the external criterion of change. It can be evaluated using the receiver operating characteristic (ROC) curve, which is constructed by calculating the sensitivity (true positive rate) and specificity (true negative rate) of the cut-off point for each of the possible score values [1]. Scores of at least 0.70 are adequate [12].

Interpretability

Various data can aid in interpreting scores such as means and SD of scores of relevant groups, as well as information about what change in score would be clinically meaningful. There are two principal methods of estimating clinically meaningful change: distribution-based and anchor-based [23,24]. Minimal detectable change (MDC), a distribution-based method, represents the smallest difference or change that would be statistically significant when comparing different samples. Minimal clinically important change (MCIC), an anchor-based method, is defined as the minimal change in the score that is meaningful for patients [25,26].

Floor and ceiling effectCeiling effects occur when subjects produce the maximum score on an instrument at baseline, thus making it impossible for the measure to detect improvement. Floor effects occur when subjects produce the lowest possible score, thus making it impossible to detect any deterioration.

Patient acceptabilityTerwee recommend that outcome measures be practical and satisfactory to the patients [12]. Patient acceptability will be defined as an instrument's simplicity to use, ease to read, coherency and ease to answer. These can be measured with completion ratios and time required by patients to complete the instrument.

Table 1. Psychometric properties and criteria.

Med Sci Monit, 2010; 16(2): RA25-36 Feise RJ et al Functional Rating Index: Literature review

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Study & language Sample size Population FRI Cronbachs alphaComparative measures

Comparative Cronbachs alpha

Feise (E) [8] 51 Spinal complaints 0.92

Bayar (T) [27] 37 Chronic low back; test 0.92

Bayar (T) [27] 37 Chronic low back; retest 0.90

Ceran (T) [28] 84 Chronic low back pain 0.96

Lee (K) [33] 180 Neck pain & healthy controls 0.88 NDI 0.92

Lee (K) [33] 180 Neck pain & healthy controls 0.88 NPDS 0.96

Lee (K) [33] 180 Neck pain & healthy controls 0.88 SFMPQ 0.82

Rebbeck (E) [34] 99 Acute whiplash 0.91 CWOM 0.76

Rebbeck (E) [34] 250 Early chronic whiplash 0.93 CWOM 0.85

Rebbeck (E) [34] 132 Late chronic whiplash 0.94 CWOM 0.83

Costa (P) [31] 140 Low back pain 0.92 RM-24 0.92

Costa (P) [32] 99 Acute & subacute low back pain 0.88 RM-24 0.90

FRI: ICC Comparative: ICCInterval between

test-retest

Feise (E) [8] 51 Spinal complaints 0.99 2 days

Bayar (T) [27] 37 Chronic low back; test 0.91 7 days

Childs (E) [30] 41 Low back pain 0.63 ODI 0.78 1 week

Chansirinukor (E) [29] 96 Work related low back pain 0.67 RM-18 0.68 3.3 months

Lee (K) [33] 40 Volunteers 0.86 NDI 0.90 37 days

Lee (K) [33] 40 Volunteers 0.86 NPDS 0.90 37 days

Costa (P) [31] 140 Low back pain 0.95 RM-24 0.95 24 hours

Costa (P) [32] 99 Acute & subacute low back pain 0.86 PSFS 0.85 24 hours

Costa (P) [32] 99 Acute & subacute low back pain 0.86 GPE 0.90 24 hours

Costa (P) [32] 99 Acute & subacute low back pain 0.86 NRS 0.94 24 hours

Costa (P)32 99 Acute & subacute low back pain 0.86 RM-24 0.94 24 hours

Table 2. Reliability data: internal consistency (Cronbachs alpha) and test-retest (ICC).*

* All but Feise [8] & Bayar [27] used ICC2,1. Roland Morris Disability Questionnaire-18 (RM-18); Roland Morris Disability Questionnaire-24 (RM-24); Neck Disability Index (NDI); Core Whiplash OutcomeMeasure (CWOM); Neck Pain and Disability Scale (NPDS); Short Form McGill Pain Questionnaire (SFMPQ); Oswestry Disability Scale (ODI); Numeric Rartting Scale (NRS); Global Perceived Effect (GPE); Patient-Specific Functional Scale (PSFS); English (E); Turkish (T); Korean (K); Portuguese (P).


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Reliability

Table2demonstratestheinternalconsistencyoftheFRIusingCronbachsalphaandtest-retestdatausingICC.ItalsocomparestheFRIhead-to-headwithothermeasures.CronbachsalphascoresforFRIvariedfrom0.96to0.88.Basedonthecriteriaforanalysis(Table1):2scoreswereratedgood,7scoreswereratedexcellent,1scoreexceed-edupperlimits.Englishversionstudiesyieldedsimilarre-sults.FRIscores(0.91,0.94)arehigherthanCWOMscores(0.76,0.83)andequivalenttofiveothermeasuresinhead-to-headcomparisons.ICCscoresforFRIvariedfrom0.63to0.99.BasedonthecriteriaforanalysisofICCscoresforallof thestudies:2 scoreswereratedmoderatereliabili-ty,and5scoreswereratedgoodreliability.Englishversionstudiesyieldedsimilarresults.FRIsscore(0.63)waslow-erthanODIsscore(0.78),butFRIwasequivalenttoeightmeasuresinhead-to-headcomparisons.

Construct validity

Table3assessesconstructvaliditydata.Pearsonscorrela-tioncoefficientscoresforFRIvariedfrom0.23to0.82(cri-teriaanalysis:1scorewasratednonetolittle,2scoreswereratedfair,13scoreswereratedmoderatetogood,4scoreswereratedverygoodtoexcellent)forpainandfunctionself-reportscalesindicatingconvergentvalidity.Withitemsthatmeasuredifferentconstructs,scoresforallofthestud-iesvariedfrom0.17to0.53(criteriaanalysis:3scoreswereratednoneto little;7scoreswererated fair;1 scorewasratedmoderatetogood),suggestingaweakerassociation.Analysisof theEnglishversionstudiesyieldedsimilarre-sults.Overall,inhead-to-headassessments,FRIhasastron-gerconvergentcorrelationthanthecomparativemeasuresforpainandfunctionself-reportscalesandacorrelationequivalenttothecomparativemeasuresforitemsthatmea-suredifferentconstructs.

Responsiveness

Tables4and5providedataaboutFRIsresponsiveness.EffectsizescoresforFRIvariedfrom0.14to2.92(50%ofthescores>0.80),andcomparativemeasurescoresvariedfrom0.10to2.53(50%ofthescores>0.80).Head-to-headscoresforFRIarehigher(0.10)than8ofthecompara-tivemeasurescoresandlower(0.10)than10ofthecom-parativemeasure.StandardizedresponsemeanscoresforFRIvariedfrom0.25to1.30(36%ofthescores>0.80),andcomparativemeasurescoresvariedfrom0.31to1.34(57%ofthescores>0.80).Head-to-headscoresforFRIarehigh-er(0.10)than8ofthecomparativemeasurescoresandlower(0.10)than7of thecomparativemeasurescores.ReceiveroperatingcurvescoresforFRIvariedfrom0.53to0.93(79%ofthescores>0.70),andcomparativemeasurescoresvariedfrom0.53to0.93(75%ofthescores>0.70).Head-to-headscoresforFRIarehigher(0.10)than1ofthecomparativemeasurescoresandlower(0.10)than2ofthecomparativemeasurescores.AnalysisoftheEnglishver-sionstudiesyieldedsimilarresultsforthesethreestatistics.

Interpretability

Intheoriginalstudy,therewerenobaselinedifferencesforgender(meanscore: female;47.03%,male46.84%)[8].

Forage,therewasatendencyforhigherscoreswithaging(meanscores:1220years,43.64%;2140years,45.75%;4160years,47.62%;61+years50.44%).

TwoEnglishversionstudies reportedMDCandMCIC.ChildsstudyshowedMDCscoreswere15%forFRIwitha head-to-head score forODI of 12.8% (n=41) [30].Chansirinukorsstudydemonstratedascoreof24.4%forFRIwithahead-to-headscoreforRM-18of41.89%(n=33)[29].OnlyonestudyhascalculatedMCIC.Theseresearch-ersfoundanMCICscoreof8.4%fortheFRIandascoreof9%forODI(n=131)[30].

Floor and ceiling effect

Fourresearchteamsfoundthattherewerenofloororceil-ingeffectsfortheFRItotalscores[3134].AnalysisoftheEnglishversionstudy thatanalyzedthese factorsyieldedthesameresults[34].

Patient acceptance

TheoriginaltestingoftheFRIfoundthat98%ofthescaleswerecompleted[8].Childsfoundameanresponserateof95%inanEnglishversionstudy[30].InaKoreantransla-tionstudy,Leefoundthatthetotalnumberofsubjectswithatleastonemissingresponsetoanitemonaquestionnairewas3%fortheFRI,36%fortheNDIand21%fortheNeckPainandDisabilityScale(NPDS)[33].TheadministrationoftheFRIinstrumentrequiredameanof64(12140)sec-ondsforapatienttocompleteand14(530)secondsforastaffmembertoscore[8].

Predictive validity

TheFRIhasbeenusedintwoEnglishversionstudiesinves-tigatingpredictionvalues.Inonestudy,theaccuracywashighestforaclinicalpredictionrulepredictingpainandlev-elofactivitylimitationasmeasuredbyFRIat9weeks[36].Intheotherstudy,FRIscoresatbaselinepredictedchro-nicity[37].Specifically,every10%increaseintheFRIin-dexreducedthelikelihoodofrecoveryby40%.

discussion

Overall,FRIscoresdemonstrateacceptablereliability,valid-ity,responsivenessandpatientacceptancewithnodetect-ablefloororceilingeffects.TheFRIappearstoperformequallywellacrossawiderangeoflanguage/culturalset-tings.Sinceitsoriginalpublicationin2001,nochangehasbeenmadetotheoriginalEnglishversionoftheFRI.FRIsharesitsrootswithODIandNDI,yethasattemptedtoim-proveclinicalutilitybyrefiningtheresponsescales.ThetimescaleforFRIresponsesisnow,whichisthesameastheODI,RMandNDIquestionnaires.Althoughaone-weekperiodmaybemoreinformativeinsomerespects[58],pa-tientsappeartopreferthenowtimeframe[59],and,ifusedrepeatedly,thistimeframeisprobablylesssuscepti-bletorecallbiasthanaskingsubjectstoaveragetheirsymp-tomsoverthepreviousweek[52].

CronbachsalphascoresforFRIcenteredongood-excel-lent,equivalent tomostmeasures inhead-to-headcom-parisons.ICCscoresforFRIcenteredonmoderate-good,


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Study & language Sample size Population Tested variable FRIs r Comparative measureComparative measure's r

Feise (E) [8] 139 Spinal complaints SF-12 Physical Component Score 0.76

Feise (E) [8] 139 Spinal complaints DRI 0.76

Bayar (T) [27] 37 Chronic low back RM-24 test 0.66

Bayar (T) [27] 37 Chronic low back NRS test 0.70

Bayar (T) [27] 37 Chronic low back RM-24 re-test 0.60

Bayar (T) [27] 37 Chronic low back NRS re-test 0.74

Ceran (T) [28] 84 Chronic low back pain RM-24 0.58

Ceran (T) [28] 84 Chronic low back pain VAS 0.35

Ceran (T) [28] 84 Chronic low back painSF-36 physical

functionfunction 0.67

Ceran (T) [28] 84 Chronic low back painSF-36 general

health 0.23

Ceran (T) [28] 84 Chronic low back pain SF-36 role, physical 0.37

Ceran (T) [28] 84 Chronic low back pain SF-36 bodily pain 0.60

Childs (E) [30] 131 Low back pain Oswestry 0.67

Costa (P) [31] 140 Low back pain RM-24 0.80

Costa (P) [31] 140 Low back pain NRS 0.67 RM-24 0.55

Costa (P) [32] 99 Acute & subacute low back pain RM-24 0.71 PSFS 0.51

Costa (P) [32] 99 Acute & subacute low back pain Pain NRS 0.63 PSFS 0.45

Costa (P) [32] 99 Acute & subacute low back pain PSFS 0.53 RM-24 0.51

Costa (P) [32] 99 Acute & subacute low back pain Pain NRS 0.63 RM-24 0.55

Rebbeck (E) [34] 481 Whiplash CWOM 0.82 SF-36 Physical summary 0.65

Rebbeck (E) [34] 481 Whiplash CWOM 0.82 NDI 0.76

Feise (E) [8] 139 Spinal complaints SF-12 Mental Component Score 0.36

Bayar (T) [27] 37 Chronic low back spinal movement test 0.17

Bayar (T) [27] 37 Chronic low back spinal movement re-test 0.02

Ceran (T) [28] 84 Chronic low back painSF-36 social function 0.53

Ceran (T) [28] 84 Chronic low back pain SF-36 vitaility 0.46

Ceran (T) [28] 84 Chronic low back pain SF-36 mental health 0.42

Table 3. Construct validity data: Pearson's correlation coefficient=r.


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similartomostmeasuresinhead-to-headcomparisons.Basedonthesedata,FRIhasdemonstratedsuitablereliability.

TheFRIscoresdemonstratedconvergentvaliditywithin-strumentsthatmeasureself-reportpainandfunction.Asexpected,divergentvaliditywasshownwithmeasureshav-ingdifferentdomainsof interest.Forexample,otherre-searchershavefoundadivergentcorrelationbetweenself-report functionscalesandspinalmovement[60].Theseresultsaresimilartoourfindings.Additionally,LeetestedaclinicalgroupandahealthygroupandfoundthatFRIscoresprovideddiscriminativevalidity(t-test;P

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Study & language Sample size Population FRI's ES Comparison measure Comparison ES FRI's SRMComparison

SRM

Feise (E) [8] 36 Cervical pain 1.24

Feise (E) [8] 17 Thoracic pain 1.61

Feise (E) [8] 14 Lumbar pain 1.24

Chansirinukor (E) [29] 143 Work related LBP 0.64 RM-18 0.44 0.70 0.44

Childs (E) [30] 131 LBP; 1month 2.92 Oswestry 2.53

Childs (E) [30] 131 LBP; 1 week 2.08 Oswestry 1.97

Lee (K) [33] 180 Neck pain 1.07 NDI 1.04 1.26 1.17

Lee (K) [33] 180 Neck pain 1.07 NPDS 1.07 1.26 1.34

Lee (K) [33] 180 Neck pain 1.07 SFMPQ 0.69 1.26 0.83

Costa (P) [31] 140 Chronic LBP 0.18 RM-24 0.10

Costa (P) [32] 99 Acute & subacute LBP 0.78 RMDQ 0.70

Costa (P) [32] 99 Acute & subacute LBP 0.78 PSFS 0.95

Costa (P) [32] 99 Acute & subacute LBP 0.78 GPE 0.99

Costa (P) [32] 99 Acute & subacute LBP 0.78 NRS 1.16

Rebbeck (E) [34] 418 Whiplash: pooled data ST 0.42 CWOM 0.45 0.61 0.59

Rebbeck (E) [34] 365 Whiplash: pooled data LT 0.55 CWOM 0.62 0.64 0.70

Rebbeck (E) [34] 88 Early whiplash-ST 0.91 CWOM 0.92 1.11 0.74

Rebbeck (E) [34] 88 Early whiplash-ST 0.91 NDI 0.73 1.11 0.93

Rebbeck (E) [34] 132 Late chronic whiplash-ST 0.65 CWOM 0.87 0.72 0.90

Rebbeck (E) [34] 132 Late chronic whiplash-ST 0.65 NDI 0.77 0.72 0.92

Rebbeck (E) [34] 93 Early whiplash-LT 1.36 CWOM 1.73 1.30 1.33

Rebbeck (E) [34] 93 Early whiplash-LT 1.36 NDI 1.05 1.30 1.04

Rebbeck (E) [34] 125 Late chronic whiplash-LT 0.69 CWOM 0.78 0.64 0.66

Rebbeck (E) [34] 125 Late chronic whiplash-LT 0.69 NDI 0.73 0.64 0.66

Rebbeck (E) [34] 198 Early chronic whiplash-ST 0.14 CWOM 0.20 0.25 0.31

Rebbeck (E) [34] 147 Early chronic whiplash-LT 0.21 CWOM 0.34 0.31 0.46

Stewart (E) [35] 101 Chronic whiplash-I 0.89 PSFS 1.40 1.02 1.13

Stewart (E) [35] 101 Chronic whiplash-I 0.89 NDI 0.95 1.02 1.16

Stewart (E) [35] 101 Chronic whiplash-I 0.89 Copenhagen 0.75 1.02 0.90

Table 4. Responsiveness data: effect size (ES) and standardized response mean (SRM).


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Table 4 continued. Responsiveness data: effect size (ES) and standardized response mean (SRM).

Study & language Sample size Population FRI's ES Comparison measure Comparison ES FRI's SRMComparison

SRM

Stewart (E) [35] 101 Chronic whiplash-I 0.89 SF-36PS 0.56 1.02 0.68

Stewart (E) [35] 101 Chronic whiplash-I 0.89 SF-36BP 0.72 1.02 0.71

Stewart (E) [35] 101 Chronic whiplash-I 0.89 NRS-PI 1.03 1.02 0.96

Stewart (E) [35] 101 Chronic whiplash-I 0.89 NRS-PB 1.40 1.02 1.20

Short Form McGill Pain Questionnaire (SFMPQ); SF-36 Bodily Pain Score (SF-36BP); SF-36 physical summary (SF-36PS); NRS Pain Bothersomeness (NRS-PB); NRS Pain Intensity (NRS-PI); English (E); Turkish (T); Korean (K); Portuguese (P); long-term (LT); short-term (ST); improved (I); low back pain (LBP).

researchersfoundanMCICscoreof8.4%fortheFRIandascoreof9%forODI[30].Aninternationalexpertpan-elestimatedMCICforODIat10%foranabsolutediffer-ence[63].Vernonreported thatMCICforNDIwasbe-tween7and20%[53].

Todate,floororceilingeffectshavenotbeenobservedforFRItotalscores.Aflooreffectmaymissclinicaldeteriora-tion,andaceilingeffectmaymissclinical improvement.FairbanksreportedthatitislikelythatODIisbetteratde-tectingchangeinmoreseriouslydisabledpatients,where-asRMmaywellhaveanadvantageinpatientswithminordisability[52].

Ideally,clinicquestionnairesshouldbeeasytoadministerandscoreandquickforpatientstocomplete[64].FRIhadahighcompletionrate(9598%)andfewmissingresponsesonanysingleitem.Inastudyusingthesamepatientpopula-tion,itwasdiscoveredthattheNDIhadnumerousmissingresponsesthatclusteredonitemnumber8(driving)[33].Similarly,Fisherfoundthat24%oftheODIquestionnaireshadmissingresponses[65].Missingresponsescancreatein-accurateassessments.Simplycalculatingapercentagescoreforthequestionsthathavebeenansweredmaynotaccu-ratelyassesstheparticipantsfunctionalstate.

A frequently ignored featureofclinicalmeasures is thepracticalityofusingtheminabusyclinicalsetting.Theusageofoutcomemeasuresinclinicalpracticehasbeenshown tobe less than50%[66,67].Themost frequent-ly reportedreasons fornotusingoutcomemeasures islengthoftimeforpatientstocompletethemandlengthoftimeforclinicianstoanalyzethedata[66,67].FRIre-quiredjustoveroneminute(78seconds)forthepatienttocompleteandastaffmembertoscore[8].Thisisexcel-lentcomparedwithNDIorODI,whichareeachestimat-edtotake5minutes[16].

Theearly identificationofpatientsat risk forchronici-ty/pooroutcomescouldbeimportanttopractitionersandpatients,becauseitmightleadtotheinitiationofamoreeffectiveinterventionalapproach.Thus,researchteamsaresearchingforpredictivetools,includingquestionnaires,toaidthisapproach.TheFRIhasbeenshowntobeusefulin

theprognosticationofoutcomesafterwhiplashinjuryandmusculoskeletalpain(mostlybackpain).Therefore,ithasbeenrecommendedthatearlyadministrationof theFRImayidentifypotentialnon-recoverers,whointurnmayre-quiremoreintensemonitoringinordertopreventchron-icdisability[36,37].

Anotherfactortoconsiderwhenselectingaquestionnaireisversatility[29].TheFRIhasbeensuccessfullyusedwithsev-eraldifferentmodesofcommunicationbeyondtheclinicalsetting:phone[37,41],interviewer-assisted[27]andpostal[36,45].TheFRIalsohasanadvantageovertheNDIandODI,becauseitwasdesignedtobeusedforpatientswithbothbackandneckpain.Whereas,theODIisforlowbackonly,andtheNDIisforneckonly.

FRIhasbeenincludedinaguideline,adatabaseandsever-aluniversity-leveltextbooks[68-73]. Ithasalsobeentrans-lated into three languages:Korean,Brazilian-PortugueseandTurkish[28,31,33].

Limitations and future research

TheauthorsoftheFRIattemptedtoperformacomprehen-sivesearchoftheliteraturesoastominimizeselectionbiasandgatherasmanyrelevantpublishedstudiesaspossible.However,theirsearchmayhavemissedsomestudies.Itisalsopossiblethattheyoverlookedsomeinfluentialunpub-lishedstudies.However,anysuchmissedstudiesprobablyhadpoormethodologicalquality.Thereisaneedformorepsychometrictesting,includingMCICestimates.Head-to-headcomparisonsprovidethebestdataforresearchersandpractitioners.CurrentlythereisnonormativedatafortheFRI.FuturestudiesshouldlookatFRIdatainanitemre-sponsetheoryanalysis.

conclusions

TheFRIdemonstratesacceptablereliability,validityandre-sponsivenesswithnofloororceilingeffects.Additionally,theFRIappearstobemorepracticalthanotherspinalin-strumentsintwoimportantrespects:itisquickerforapa-tienttocomplete,anditcanbeusedforpatientswithbothneckandbackpain.


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Study & language Sample size Population FRI's ROC Comparison measure Comparison ROC

Chansirinukor (E) [29] 143 Work related low back pain 0.74 RM-18 0.69

Childs (E) [30] 131 Low back pain 0.93 Oswestry 0.93

Lee (K) [33] 180 Neck pain 0.79 NDI 0.79

Lee (K) [33] 180 Neck pain 0.79 NPDS 0.79

Lee (K) [33] 180 Neck pain 0.79 SFMPQ 0.63

Costa (P) [32] 99 Acute & subacute low back pain* 0.53 RMDQ 0.53

Costa (P) [32] 99 Acute & subacute low back pain* 0.53 PSFS 0.68

Rebbeck (E) [34] 418 Whiplash: pooled data short-term 0.77 CWMO 0.73

Rebbeck (E) [34] 418 Whiplash: pooled data short-term 0.77 NDI 0.75

Rebbeck (E) [34] 365 Whiplash: pooled data long-term 0.79 CWMO 0.81

Rebbeck (E) [34] 365 Whiplash: pooled data long-term 0.79 NDI 0.79

Rebbeck (E) [34] 132 Late chronic whiplash: short-term 0.81 CWMO 0.73

Rebbeck (E) [34] 132 Late chronic whiplash: short-term 0.81 NDI 0.75

Rebbeck (E) [34] 93 Early whiplash: long-term 0.76 CWMO 0.87

Rebbeck (E) [34] 93 Early whiplash: long-term 0.76 NDI 0.79

Rebbeck (E) [34] 125 Late chronic whiplash: long-term 0.78 CWMO 0.78

Rebbeck (E) [34] 125 Late chronic whiplash: long-term 0.78 NDI 0.77

Rebbeck (E) [34] 198 Early chronic whiplash: short-term 0.57 CWMO 0.59

Rebbeck (E) [34] 147 Early chronic whiplash: long-term 0.67 CWMO 0.62

Rebbeck (E) [34] 93 Early whiplash: short-term 0.67 CWMO 0.73

Rebbeck (E) [34] 93 Early whiplash: short-term 0.67 NDI 0.74

Stewart (E) [35] 132 Chronic whiplash 0.79 PSFS 0.71

Stewart (E) [35] 132 Chronic whiplash 0.79 NDI 0.76

Stewart (E) [35] 132 Chronic whiplash 0.79 Copenhagen 0.73

Stewart (E) [35] 132 Chronic whiplash 0.79 SF-36PS 0.70

Stewart (E) [35] 132 Chronic whiplash 0.79 SF-36BP 0.73

Stewart (E) [35] 132 Chronic whiplash 0.79 NRS-PI 0.68

Stewart (E) [35] 132 Chronic whiplash 0.79 NRS-PB 0.70

Table 5. Responsiveness data: Receiver operating curve (ROC).

* Mean of 3 different cut-off points; Short Form McGill Pain Questionnaire (SFMPQ); SF-36 Bodily Pain Score (SF-36BP); NRS Pain Bothersomeness (NRS-PB); SF-36 physical summary (SF-36PS); NRS Pain Intensity (NRS-PI); English (E); Turkish (T); Korean (K); Portuguese (P).


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