Research Article Hyperacusis Questionnaire as a Tool for Measuring Hypersensitivity to Sound in a Tinnitus Research Population

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1 BioMd Rsarch Intrnational Volum 2015, Articl ID , 12 pags Rsarch Articl Hypracusis Qustionnair as a Tool for Masuring Hyprsnsitivity to Sound in a Tinnitus Rsarch Population Kathryn Fackrll, 1,2 Constanc Farnly, 3 Drk J. Hoar, 1,2 and Magdalna Srda 1,2 1 NIHR Nottingham Haring Biomdical Rsarch Unit, Nottingham NG1 5DU, UK 2 Otology and Haring Group, Division of Clinical Nuroscinc, School of Mdicin, Univrsity of Nottingham, Nottingham NG7 2RD, UK 3 School of Mdicin, Univrsity of Nottingham, Nottingham NG7 2RD, UK Corrspondnc should b addrssd to Magdalna Srda; magdalna.srda@nottingham.ac.uk Rcivd 17 April 2015; Rvisd 17 Jun 2015; Accptd 15 July 2015 Acadmic Editor: Tobias Klinjung Copyright 2015 Kathryn Fackrll t al. This is an opn accss articl distributd undr th Crativ Commons Attribution Licns, which prmits unrstrictd us, distribution, and rproduction in any mdium, providd th original work is proprly citd. Hyprsnsitivity to xtrnal sounds is oftn comorbid with tinnitus and may b significant for adhrnc to crtain typs of tinnitus managmnt. Thrfor, a clar masur of snsitivity to sound is important. Th aim of this study was to valuat th validity and rliability of th Hypracusis Qustionnair (HQ) for us as a masurmnt tool using data from a sampl of 264 adults who took part in tinnitus rsarch. W valuatd th HQ factor structur, intrnal consistncy, convrgnt and discriminant validity, and floor and ciling ffcts. Intrnal consistncy was high (Cronbach s alpha = 0.88) and modrat corrlations wr obsrvd btwn th HQ, uncomfortabl loudnss lvls, and othr halth qustionnairs. Confirmatory factor analysis rvald that th original HQ thr-factor solution and a on-factor solution wr both a poor fit to th data. Four problmatic itms wr rmovd and xploratory factor analysis idntifid a two-factor (attntional and social) solution. Th original thr-factor structur of th HQ was not confirmd. All fourtn itms do not accuratly assss hyprsnsitivity to sound in a tinnitus population. W propos a 10-itm (2-factor) vrsion of th HQ, which will nd to b confirmd using a nw tinnitus and prhaps nontinnitus population. 1. Introduction Hypracusis is most commonly dfind as incrasd snsitivity to ordinary nvironmntal sounds that would not usually b bothrsom to most individuals [1 3].Hypracusisisa broad spctrum condition affcting individuals to various dgrs. Th main diffrnc btwn hyprsnsitivity to sound and conditions such as phonophobia (far of sound) and misophonia (dislik of sound) is that th lattr two usually involv an motional rspons to spcific sounds [4]. Loudnss rcruitmnt (abnormal growth in th prcption of loudnss) may b a distinct condition or can accompany hypracusis in popl with cochlar haring loss. Baguly [5] suggstd that loudnss rcruitmnt can b distinguishd from hyprsnsitivity to sound basd on th intnsity of th sounds prcivd as uncommonly loud (modrat intnsity in th cas of loudnss rcruitmnt and low intnsity in th cas of hypracusis). H also nots that loudnss rcruitmnt, unlik hypracusis, dos not vary with mood. Prvalnc of hyprsnsitivity to sound in adults is stimatd at 8 or 15% [6, 7]. It can influnc motional wll-bing, haring, slp, and concntration, caus anxity, andintrfrwithspchprcptioninnois[8, 9]. It is stimatd that about half of patints with hypracusis also hav a psychiatric or anxity disordr [10]. Among th possibl tiologis of hypracusis ar conditions involving th priphral auditory systm (.g., Bll s palsy, Ramsay Hunt syndrom, nois-inducd haring loss, Ménièr s disas), disass and syndroms of cntral nrvous systm (.g., hadachs, dprssion, had injury, Williams s syndrom, larning disabilitis, spinal problms), and hormonal (.g., Addison s disas) and infctious disass (.g., lym disas). Howvr, in most cass hyprsnsitivity to sound has no known caus [3].

2 2 BioMd Rsarch Intrnational Hyprsnsitivity to sound and tinnitus (prcption of sound or nois in th absnc of any xtrnal acoustic stimulation [11]) ar oftn comorbid. Th prvalnc of tinnitus among popl with hyprsnsitivity to sound is much highr than in th gnral population and with stimats of 40% [12], 79% [10], and 86% [13]. Similar to tinnitus, thr ar svral potntial pathophysiological mchanisms that might lad to hyprsnsitivity to sound and similar to tinnitus thos mchanisms ar not mutually xclusiv. Incrasd prvalnc of hyprsnsitivity to sound in a numbr of conditions points to 5-hydroxytryptamin (5-HT) dysfunction as on likly mchanism [3, 14]. Intrstingly a link btwn tinnitus and 5-HT dysfunction has also bn proposd [3]. On of th postulatd functions of 5-HT in th auditory systm is modulating cntral gain [15]. Jastrboff and Hazll [16] dscribd hyprsnsitivity to sound as a prtinnitus stat as it oftn occurs bfor th onstoftinnitus.thypostulatdthathyprsnsitivityto sound is an ffct of an incrasd gain in th cntral auditory systm. Incrasd cntral gain has also bn postulatd as on of th possibl mchanisms of tinnitus gnration [17, 18]. Association btwn hyprsnsitivity to sound, tinnitus, and priphral auditory systm damag prsnt in stapdctomy, Mnirs s disas, and snsorinural haring loss ld to hypothss assuming priphral contribution to th gnration of hyprsnsitivity to sound [14]. Th strong association btwn hyprsnsitivity to sound and tinnitus may hav srious implications for rsarch and managmnt of both conditions. Both may hav a significant influnc on pattrns of auditory activity in rspons to xtrnal sounds. Th importanc of controlling for hyprsnsitivity to sound in nuroimaging studis of tinnitus has bn highlightd in a study by Gu t al. [19] who dmonstratd that th incras in nuronal xcitability to sounds in tinnitus patints(prviouslyassociatdwithtinnitus)maybascribd to hyprsnsitivity to sound rathr than to a mchanism spcifically rlatd to tinnitus. Svral studis point to an association btwn tinnitus annoyanc and th prsnc of hyprsnsitivity to sound [20, 21] whr tinnitus annoyanc is highr in patints with comorbid hyprsnsitivity to sound. Th prsnc of hyprsnsitivity to sound can also influnc th accptability and adhrnc to crtain tinnitus managmnt options such as sound thrapy. Thrfor, a rliabl masur of hyprsnsitivity to sound is important for tinnitus managmnt. Thr is no standard protocol for valuating hyprsnsitivity to sound. Th most common approach includs historytakingandmasuringuncomfortabl loudnss lvls (ULLs) as a first stp in th diagnosis [22]. In popl with hyprsnsitivity to sound ULLs ar usually lowr than avrag ovr all or spcific frquncis in both or on ar [5]. AccordingtoP.J.JastrboffandM.M.Jastrboff[22], th avrag ULLs for patints rporting problms with sound tolranc ar btwn 60 and 85 db HL, whilst for all othr patints 100 db HL. ULLs of 70 db HL or lss wr suggstd by Anari and collagus as a critrion for diagnosis of hyprsnsitivity to sound [13, 23]. On common problm with masuring ULLs is high variability and strong dpndnc of thrsultsonthinstructiongivn.studisthatusddiffrnt instructions found that th diffrnc in ULLs rangd from 23 to 27 db HL dpnding on th frquncy [24, 25]. For instanc, Dawson Jr. [24] foundthat,inpoplwithnormal haring and no complaint of hyprsnsitivity to sound, ULLs wr as low as 68 db HL for 250 Hz, which will b diagnosd as hyprsnsitivity to sound according to th dfinition of Anari and collagus [13]. Tst-rtst rliability of ULLs has bn qustiond [26]. Thrfor, vidnc for th utility of ULLs is mixd. Patint-rportd outcom masurs (qustionnairs) ar usd to masur hyprsnsitivity to sound spcific halth rlatdqualityoflifandtodiagnoshypracusis.asmall numbr of qustionnairs hav bn dvlopd to dat, including th Grman Qustionnair on Hyprsnsitivity to Sound (G ÜF[27]; Grman vrsion validatd in tinnitus patints by Bläsing t al. [28]). Th G ÜFasssssth subjctiv distrss associatd with hyprsnsitivity to sound which was considrd a bttr indicator of tratmnt nds than audiological findings [28]. Th Grman vrsion of th qustionnair has bn usd in rsarch [29]. Although th English translation of th qustionnair is availabl, this vrsion has not bn validatd and has not bn usd in th clinics or rsarch. Th Multipl-Activity Scal for Hypracusis (MASH) [30] is an intrviw-basd qustionnair which asssss lvl of annoyanc in rlation to hyprsnsitivity to sound. Finally, th Hypracusis Qustionnair (HQ) [31] was dvlopd and a Frnch vrsion was validatd using a gnral population who did not ncssarily complain of snsitivity to sound. During dvlopmnt of th HQ normativ data wr usd to stimat that a scor gratr than 28 was significantly diffrnt to th population total man scor of 15 points and so this was takn to rprsnt strong auditory hyprsnsitivity (hypracusis) (maximum possibl scor = 42) [31]. Using xploratory factor analysis, thr factors wr idntifid for th HQ (attntional, social, and motional), but togthr thy only accountd for 48% of th varianc; that is, thr was a lot of unxplaind varianc and likly masurmnt rror [32]. Factor loadings wr all abov 0.3. Minor cross loading in particular in th social factor lads us to qustion th uniqunss of th subscals. Mus and collagus [33] prformd validation of a Dutch vrsion of th qustionnair and idntifid four subscals using xploratory factor analysis. This furthr calls into qustion th rliability of th original qustionnair structur idntifid by Khalfa and collagus [31]. Exploratory factor analysis is rcommndd during th dvlopmnt of qustionnairs as it xplors all possibl intrrlationships btwn th st of obsrvd variabls without postulating a thortical structur. Howvr, confirmatory factor analysis is ncssary to assss a prmdiatdstructurbasdonthoryor/andxploratory factor analysis findings [34, 35]. To dat th psychomtric proprtis, in particular th original structur of th HQ, hav not bn confirmd or assssd in a UK population; no confirmatory factor analysis has bn conductd. Yt, th qustionnair is usd in tinnitus rsarch studis as a scrningtoolforxclusionofparticipantswithhypracusis[36 39] and as an outcom masur of tratmnt-rlatd chang [10, 33], although it was not dsignd with this purpos in mind [31].

3 BioMd Rsarch Intrnational 3 Tabl 1: Dscriptiv statistics for th study masurs. Qustionnair/subscal Numbr of itms Total rang Dscriptiv statistics Rliability Man SD Rang α N Hypracusis Qustionnair [31] Attntional Social Emotional Tinnitus Handicap Invntory (THI) [46] Tinnitus Handicap Qustionnair (THQ) [45] Bck s Dprssion Invntory-II (BDI-II) [47] Bck s Dprssion Invntory-Fast Scrn (BDI-FS) [49] Bck s Anxity Invntory (BAI) [48, 55] Uncomfortabl loudnss lvls at 1 khz (db HL) Th maximum scor is 42 for th HQ, 100 for THI and THQ, 63 for BDI and BAI, and 21 for th BDI-FS. Th rliability alpha (α)isprsntdforthhqtotal and subscal scors. N = ffctiv sampls. Thaimofthisstudywastompiricallyvaluatth validity and rliability of th HQ for us as masurmnt tool in a spcific population, that is, adults taking part in tinnitus rsarch. Th psychomtric validation rportd hr focuss on valuating th original thr-factor structur of th HQ, particularly itm idntification with th thr factors and th rlationship btwn th thr factors and th ovrall hyprsnsitivity to sound construct (scor), and th rliability (intrnal consistncy), validity (discriminant validity), and rsponsivnss (floor and ciling ffcts) of th HQ using a larg UK population of rsarch participants with tinnitus. 2. Matrials and Mthods 2.1. Participants and Procdurs. Th study was a rtrospctiv analysis of data collctd during a sris of tinnitus rsarch studis conductd at th NIHR Nottingham Haring Biomdical Rsarch Unit and MRC Institut of Haring Rsarch btwn 2008 and Studis includd randomisd controlld trials (RCTs) [40, 41], clinical cohort studis [42, 43], an imaging study using magntoncphalography [38, 39], and a fasibility study [44]. In thos studis th HQ was usd ithr as a scrning tool for xclusion of participantswith hypracusis [39 41, 43] or for classification of participants [38]. Additional assssmnts includd th Tinnitus Handicap Qustionnair (THQ) [45]; Tinnitus Handicap Invntory (THI) [46]; Bck s Dprssion Invntory-II (BDI-II) [47]; Bck s Anxity Invntory (BAI) [48]; Bck s Dprssion Invntory-Fast Scrn (BDI-FS) [49]; uncomfortabl loudnss lvls (ULLs). In som cass participants had compltd th ligibility assssmnts for mor than on study; to prvnt an ovrlap in th data, for ths participants only on st of qustionnair data was usd. In ths cass, th most complt datast was chosn. In total, 264 popl with tinnitus (158 mal, 106 fmal) with an avrag ag of 58.7 yars (rang: 24 to 85 yars) compltd th HQ and som or most of th assssmnt qustionnairs. Forty popl compltd ULL assssmnt Missing Data. Only participants who compltd th HQ wr includd (n = 264). Du to variability in th ligibility assssmnts or bcaus of participants bing withdrawn at diffrnt points in thir assssmnt, not all 264 participants complt all of th othr assssmnts. For th convrgnt and discriminant validity thrfor, w conductd pairwis dltion to nabl th us of most data; th ffctiv sampls forach comparisonarproviddintabl Masurs Hypracusis Qustionnair (HQ). Th HQ is a twopart qustionnair. Th first part consists of binary qustions which aim to gathr gnral information of auditory disordrs and nois xposur, whilst th scond part consists of 14 ngativly wordd itms, which ar ratd on a 4-point scal: no (0 points), ys, a littl (1 point), ys, quit a lot (2 points), and ys, a lot (3 points). Th total provids th masur of hyprsnsitivity to sound with highr scors indicating gratr snsitivity. Th man global scor rangs from 0 to 42 and a global scor >28 indicats hypracusis [31]. Itms rlatd to th thr subscals can also b summd to provid subscal scors TinnitusHandicapInvntory(THI). Th THI quantifis th impact of tinnitus on daily living [46, 50]. For instanc, itm1asks Bcausofyourtinnitusisitdifficultforyou to concntrat?. Each of 25 itms is ratd on a 3-point scal: ys (4 points), somtims (2 points), and no (0 points). Th man global scor rflcts th sum of all rsponss with a global scor of 100 indicating gratst impact on vryday function. Scors ar intrprtd using th following catgoris: slight problm (0 16), mild (18 36), modrat (38 56), svr (58 76), and catastrophic (78 100) [51]. Nwman t al. [46] dscribd thr subscals masuring functional, motional, and catastrophic impact of tinnitus. Howvr, th rliability of ths subscals has bn qustiond [52].

4 4 BioMd Rsarch Intrnational Tinnitus Handicap Qustionnair (THQ). Th THQ masurs th prcivd dgr of handicap associatd with tinnitus [45]. For xampl, itm 1 asks I hav support from my frinds rgarding my tinnitus. For ach of 27 itms, participants assign a numbr btwn 0 (strongly disagr) and 100 (strongly agr) to indicat thir agrmnt. All itms ar ngativ dscriptors with th xcption of two itms which ar rvrs-scord bfor all th rsponss ar summd and wightd to giv a global scor out of 100. Kuk t al. [45] idntifid thr subscals ((1) physical, motional, and social ffcts; (2) haring and communication ability; (3) individual s prcption of tinnitus) but only subscals 1 and 2 wr found to b rliabl [45] Bck s Dprssion Invntory-II (BDI-II). Th BDI-II masurs svrity of dprssiv symptoms [47, 53, 54]. For ach of 21 itms, participants slct on of four statmnts (scoring 0 3 points) according to how thy hav flt ovr th prvious two wks. For xampl, itm 1 masurs sadnss: (0) I do not fl sad ; (1) I fl sad much of th tim ; (2) I amsadallthtim ;(3) IamsosadorunhappythatIcannot stand it. Highr scors indicat incrasd lvls of dprssiv symptomatology. Rsponss ar summd to form a global scor out of 63, with a scor of catgorisd as svr dprssion and a scor of ovr 40 as xtrm dprssion [47] Bck s Dprssion Invntory-Fast Scrn (BDI-FS). Th BDI-FS is a quickr quantitativ scrn for dprssion than th BDI, which xcluds symptoms possibly rlatd to othr mdical conditions [49].Each of th 7 itms is ratd on a 4-point scal (scoring 0 3 points) with four dscriptor statmnts. Rsponss ar summd to form a global scor out of 21, with a highr scor indicating a highr lvl of dprssion Bck s Anxity Invntory (BAI). Th BAI masurs 21 common symptoms of clinical anxity [48, 55, 56]. Participantsindicatthdgrtowhichthparticularsymptom has bothrd thm ovr th prvious wk by slcting on of four rspons options (0 to 3). For xampl, itm 1 masurs numbnss or tingling: (0) Not at all ; (1) Mildly; it did not bothr m much ; (2) Modratly; it was vry unplasant, but I could stand it ; (3) Svrly; I could barly stand it. Againrsponssarsummdtogivaglobalscoroutof63. Scors of 0 21 indicat vry low anxity and scors xcding 36 indicat caus for concrn [48, 55] Uncomfortabl Loudnss Lvls (ULLs). Th ULLs of 40 participants wr masurd across two of th includd studis [38, 39]. ULLs wr tstd using a 1 khz pur ton dlivrd to ach ar using an audiomtr. Tons wr prsntd for 1 scond with 1 scond quit priods and incrasd in 5 db stps until th participant rspondd that th sound had rachd an uncomfortabl lvl. All participants had normal haring thrsholds at 1 khz. ULLs wr conductd for both ars and avragd to giv a man ULL valu at 1 khz for ach individual Statistical Analysis Factor Structur: Confirmatory Factor Analysis. Confirmatory factor analysis (CFA) was conductd on HQ data from264patintswithtinnitustotstthfitofth3-factor structur dvisd by Khalfa t al. (Figur 1) [31]. Following this, to valuat a modifid vrsion of th HQ, th full datast (N: 264) was randomly split into two similar sizd indpndnt groups: sampl A (50% N: 132) andsampl B (50% N: 132). CFA was conductd on th data from sampl A to tst th fit of a on-factor structur. Data from sampl B wr usd for xploratory factor analysis (mthod blow). CFA modls wr spcifid and stimatd using Mplus vrsion 7 [57]. Th 3-factor modl includd (i) on scond-ordr factor consistnt with th global masur of hyprsnsitivity to sound (varianc fixd at 1) and thr first-ordr factors corrsponding to th thr HQ subscals (attntional, social, and motional), (ii) fourtn obsrvd variabls, ach frly stimatd on thir dsignatd factor with zro loadings on th othr factors with rror varianc assumd to b uncorrlatd and random (constraind to zro). Th on-factor modl was spcifid to includ on gnral factor corrsponding to hyprsnsitivity to sound, with fourtn obsrvd variabls corrsponding to th 14 itms of th HQ and uniqunss varianc associatd with ach itm. All 14 itms of th HQ wr ratd using polytomous scal. Th data wr modlld accordingly as catgorical variabls using th robust wightd last squars stimator (WLSMV) in Mplus [57]. Compard to othr mthods such as maximum liklihood (ML) and wightd last squars (WLS), WLSMV producs robust stimations, in particular robust standard rror and adjustd Chi-squar tst statistics (χ 2 ) for catgorical data with small sampl sizs and nonnormality in th data [58, 59]. In this study sinc all variabls ar catgorical, WLSMV is stimatd using polychoric corrlation matrix of th undrlying continuous rspons variabls. Ths latnt rsponss ar rlatd to th thrshold paramtrs of th obsrvd catgorical variabls, in which th thrsholds rflct th position on th undrlying continuous and normally distributd charactristic that distinguishs th catgorisofthobsrvdpolytomousvariabl[58]. Th factor intrcorrlations wr initially xamind to accss th dgr in which th factor rlats to on anothr and ovrlaps in contnt bfor th modl as a whol was valuatd (th scond-ordr componnt of th modl). Highly corrlatd factors (>0.85) ar vidnc of poor distinction btwn constructs (poor discriminant validity). Wakly corrlatd factors (<0.30) indicat unrlatd contnt that is potntially masuring an altrnativ undrlying construct [58, 60]. Th goodnss of fit was dtrmind using WLSMV χ 2 [61], Comparativ Fit Indx (CFI) [62], Tuckr-Lwis Indx (TLI) [63], and wightd root-man-squar rsidual (WRMR) [57]. An indication of good modl fit is a small nonsignificant χ 2 stimat (p < 0.05) thatrlativtoth dgrs of frdom is 2.0,CFIandTLIstimatsthat xcd 0.90 (prfrably xcding 0.95) [64], and WRMR valus blow Root Man Squar Error of Approximation (RMSEA) [65] and confidnc intrvals (CIs) wr rportd

5 BioMd Rsarch Intrnational 5 Scond-ordr factor 1 Hypracusis First-ordr factor Attntional Social Emotional HQ1 HQ2 HQ3 HQ4 HQ5 HQ6 HQ7 HQ8 HQ9 HQ10 HQ11 HQ12 HQ13 HQ14 Figur 1: Thortical 3-factor structur of th Hypracusis Qustionnair (HQ). Th modl rprsnts th proposd rlationships btwn th itms (obsrvd variabls), th first-ordr factors consistnt with attntional, social, and motional subscals, and th scond-ordr factor consistnt with th global masur of hyprsnsitivity to sound (varianc fixd at 1). Varianc fixd at 1 for scond-ordr factor and itms 2, 5, and 11. Th unidirctional black arrows rprsnt th dirct ffcts of th scond-ordr factor onto th thr first-ordr factors and th dirct ffcts of th first-ordr factors onto th obsrvd variabls. Th fourtn obsrvd variabls ar rprsntd as HQ1 to HQ14, with all itms only associatd with thir dsignatd factor. Th unidirctional gry arrows rprsnt th rror varianc () associatd with ach variabl, ach frly stimatd on thir dsignatd factor with zro loadings on th othr factors with rror varianc assumd to b uncorrlatd and random (constraind to zro). = rsidual varianc (rror and uniqunss trms). with valus of lss than 0.05 and CIs within 0.08 indicating accptabl fit [58, 64, 66, 67]. Ths cut-off points srv as guidlins for accptabl fit for th modl that should b valuatd alongsid th othr CFA findings, that is, th factor loadings [67]. Tocomparthonandthrfactormodls,thcorrct χ 2 diffrnc tsts for nstd modls wr assssd using th DIFFTEST command in Mplus [57, 58]. Squard standardisd factor loadings provid th basis for intrprtation of th factor loading stimats with catgorical data. Squard standardisd factor loadings (and standardisd factor loadings) wr thrfor xamind to valuat th amount of varianc in th undrlying continuous rspons variabl xplaind by th latnt constructs (first-ordr and scond-ordr factors). Th strngth of ths loadings is rlativ to th amount of varianc by th modl; thrfor, th highr th loading valu, th lss th rror associatd with th modl and th bttr th fit. Altrnativly, low loadings (<0.4) indicat masurmnt rror and ar a potntial sourc of poor modl fit [34, 60]. Modification Indx (MI) was usd to idntify any misspcification in th paramtrs of th modl, with valus xcding 10 indicating a sourc of poor modl fit [60]. Th Expctd Paramtr Chang (EPC) valu was usd to idntify th magnitud of improvmnt to modl fit if th paramtrs wr frly stimatd in a subsqunt analysis. Togthr, ths wr only usd to idntify which paramtrs couldbadjustdifthysignificantlyimprovdmodlfitand wr supportd by concptual foundations [60, 68] Factor Structur: Exploratory Factor Analysis. Data from sampl B wr modlld in xploratory factor analysis using th WLSMV stimator and obliqu rotations [58, 69]. Following th Kaisr critria, factors with ignvalus abov 1 wr xtractd [70]. Th scr plot was also xamind to confirm factor xtraction. Communalitis wr assssd for ach itm with communalitis blow 0.5 takn to indicat a larg amount of unxplaind varianc [32, 58, 71]. Factor loadings wr considrd maningful if thy xcd 0.40 [34], but to assss cross-loading, th loading stimats should b blow 0.30 [72] Psychomtric Proprtis. Th rliability, validity, and rsponsivnss of th HQ wr assssd. All statistical analyss wr prformd in SPSS (v.22.0) Rliability: Intrnal Consistncy. Intrnal consistncy wasmasurdascronbach salphawithstimatsα > 0.7 and α < 0.9 takn to indicat accptabl intrnal consistncy [32, 73].

6 6 BioMd Rsarch Intrnational Validity: Convrgnt and Discriminant Validity. Convrgnt validity and discriminant validity wr valuatd as Sparman s bivariat corrlations. Du to th clos rlationship btwn tinnitus and hyprsnsitivity to sound (common problms with concntration/attntion, strss, haring difficultis, participation), th HQ was prdictd to modratly corrlat with tinnitus qustionnairs, that is, modrat discriminant validity. Th HQ was prdictd to also show modrat corrlations with gnralisd dprssion and anxity, bcaus hyprsnsitivity to sound is associatd with both [8, 74] Rsponsivnss: Floor and Ciling Effcts. Th HQ was not dsignd for us as an outcom masur; howvr, somstudisstillusitforthatpurpos[33, 40]. Thrfor, w lookd for floor and/or ciling ffcts which would compromis th rliability and rsponsivnss of th HQ to maningful changs, although this dos not ncssarily rflct ral world chang. Rspons frquncy distributions wr xamind to dtct floor or ciling ffcts at itm lvl. Floor or ciling ffcts wr idntifid as itms whr mor than 15% of rspondnts ratd th lowst or highst possibl rspons option ( no (0) or ys, a lot (3) on a 4-point scal) [32]. Problmatic itms with floor ffcts ar unlikly to dtct rductions in hyprsnsitivity, whilst itms with ciling ffcts hav limitd snsitivity to incrass in hyprsnsitivity. 3. Rsults 3.1. Inspction of th Distribution of Scors. Dscriptiv statisticsforallqustionnairmasursarshownintabl 1.Man scors for all th qustionnairs wr at th lowr nd of th scoring rang, with BDI, BAI, and BDI-FS rcording th lowst mans rlativ to thir maximum possibl scor. Scors for tinnitus svrity in rlation to th THI grading systm wr modrat (<38/100 in ach cas). Frquncy distributions for global HQ scors ar givn in Figur 2. Th HQ scors wr slightly skwd towards th lowr nd of th scals, with a man scor of This man scor was almost idntical to th man qustionnair scor (15.0) idntifid by Khalfa and collagus [31]. Just undr half th participants (124 out of 264) wr abov 14.7, whilst only 19 out of th 264 participants wr abov 28 and thrfor wr idntifid as xprincing hypracusis Factor Structur: Confirmatory Factor Analysis Thr Factor Structur. First-ordr factor corrlations, standardisd factor loadings, standard rror, and squard standardisd factor loadings for th obsrvd variabls and latnt constructs ar summarisd in Tabl 2. Corrlations btwn th first-ordr factors (thr subscals) wr abov 0.70 (Tabl 2), indicating that thr was a dgr of ovrlap btwn th factors. Modl fit was poor; th WLSMV χ 2 was significant ( (df = 75), p < 0.001), and rlativ to th dgrs of frdom, th stimat was significantly highr (3.74) than th critical ratio cutoff ( 2.0). Although th TLI (0.92) and CFI Frquncy HQ scors Figur 2: Distribution of Hypracusis Qustionnair total scors. Th diagnostic critrion is rprsntd with a black bold lin ( ). Thmanscorforthcurrntstudyisprsntdasablackbold dottd lin ( ). According to th critria idntifid by Khalfa t al. [31], only 7% of participants indicat hyprsnsitivity, whilst 47% of participants wr abov our man scor. (0.94) wr both within th accptabl critria (marginally blow 0.95), both th RMSEA (0.1; CI = ) and WRMR (1.28) stimats wr xcptionally highr than th aprioricutoff for stablishing adquat fit. Examination of th squard standardisd factor loadings showd that all thr first-ordr factors (attntional, social, and motional) had high loading valus with th scondordr factor (ovr 70% of varianc). Th loading valus for th itms rangd from 0.09 to 0.87, with th majority abov 0.4. For tn itms ovr 50% of th varianc was xplaind by th first-ordr factor in which th itms ar assignd to. For th rmaining four itms, th standardisd factor loadings wr low (<0.6), with itm 1 blow accptabl (0.3). Th squard loading valus mirrord ths loadings (<0.4). Th social factor only xplaind 32% of th varianc in itms 5 and 6, th motional factor xplaind 33% varianc in itm 11, and th attntional factor only xplaind an unaccptabl 9% varianc in itm 1. Thr is a larg amount of masurmnt rror that th modl cannot xplain. Examination of th modification indx rvald th prsnc of 18 larg modification indics (>10). Ths MIs indicatd srious cross-loading btwn ach factor and a numbr of itms. Th EPC valus indicat that if ths paramtrs wr frly stimatd, thn th improvmnt tothmodlwouldbmarginal.dutothamountof MIs, th small EPC valus, and th fact that th modl has poorfitstatistics,itwouldmaknologicalsnstoadjust ths paramtrs. A on-factor modl might provid a bttr xplanation for th data On-Factor Structur. Modl fit again was poor; th WLSMV χ 2 ( (df = 77), p < 0.001) andallapproximation fit indics faild to mt critria for a good fit. Th squard standardisd factor loadings indicatd th sam problmatic itms (Tabl 2). Th corrct χ 2 diffrnc tsts

7 BioMd Rsarch Intrnational 7 Tabl 2: Standardisd factor loadings (standard rror), R-squard valus, and factor corrlations for th thr-factor modl and on-factor modl of th Hypracusis Qustionnair. Thr-factor modl On-factor modl F1 F2 F3 R 2 F1 R 2 Itms HQ (0.07) (0.10) 0.05 HQ (0.04) (0.05) 0.54 HQ (0.03) (0.05) 0.53 HQ (0.02) (0.03) 0.72 HQ (0.05) (0.07) 0.31 HQ (0.06) (0.06) 0.42 HQ (0.05) (0.05) 0.59 HQ (0.04) (0.05) 0.43 HQ (0.03) (0.04) 0.64 HQ (0.04) (0.05) 0.64 HQ (0.05) (0.07) 0.27 HQ (0.03) (0.04) 0.66 HQ (0.05) (0.06) 0.43 HQ (0.03) (0.04) 0.57 Construct Hyprsnsitivity to sound 0.88 (0.03) 0.86 (0.03) 0.87 (0.03) R Factor corrlations F1 1 F (0.04) 1 F (0.03) 0.75 (0.04) 1 Th factor loadings (standard rrors) and squard factor loadings (R-squard) for th 14 itms and th first-ordr factors (thr-factor modl only). Th valus prsntd in bold hav poor associations with thir dsignatd factor, all blow th rcommndd cutoff < Th corrlations btwn th first-ordr factors wr all strong. R 2 = R-squard. α = Cronbach s alpha. HQ = Hypracusis Qustionnair; F1 =attntional;f2 =social;f3 =motional. Tabl 3: Exploratory factor analysis: factor loadings, communalitis, and ignvalus for th two-factor xtraction. Itms F1 F2 Communality HQ2 Hardr to ignor sounds in vryday situations HQ3 Troubl rading in nois HQ4 Troubl concntrating in nois HQ7 Particularly snsitiv to or bothrd by nois HQ8 Nois unplasant in crtain situations HQ9 Think about th nois bfor going out HQ10 Turn down invitation bcaus of nois HQ12 Strss and tird nss rduc ability to concntrat HQ13 Lss abl to concntrat at nd of day HQ14 Crtain sounds caus strss and irritation Eignvalus Th factor loading stimats prsntd in bold ar abov th rcommndd cutoff (>0.4) and indicat which factor th itm is associatd with. Two itms show cross-loading, with stimats abov 0.3 on th scond factor for itm 14, whilst itm 7 dos not load onto ithr factor. F1 =attntional;f2 =social. indicat that th rstrictd on-factor modl significantly dgrads th fit of th modl (χ 2 diff (2) = , p < 0.001). Ths findings suggst that on-factor modl dos not provid an altrnativ solution for th data Exploratory Factor Analysis. Having rmovd th four problmatic itms idntifid in both CFA modls (itms 1, 5, 6, and 11), th data from sampl B was modlld using WLSMV and obliqu rotations stimats. Examination of th ignvalus (>1) andscr plot rvalda two-factorsolution (Tabl 3). Factor 1 consists of 6 itms (attntional itms) and factor 2 consists of 3 itms (social itms). On itm (Itm 7) did not load onto ithr factor, with low loading stimats across both (<0.4). Itms hav loading stimats abov th dsird critria and show minimal vidnc of cross-loading, xcpt for itm 14. For th most part, th communalitis wr

8 8 BioMd Rsarch Intrnational Attntional Social Emotional Tabl 4: Intritm corrlations btwn all fourtn itms of th Hypracusis Qustionnair. Attntional Social Emotional Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Q13 Q14 Q1 1 Q Q Q Q Q Q Q Q Q Q Q Q Q Corrlations rangd from xtrmly low to high. Th majority of th itms showing low to modrat corrlations with ach othr. Corrlations prsntd in bold ar blow th rcommndd cutoff (0.3), indicating wak rlationships btwn itms. accptabl (>0.50), xpct for itm 2 and again itm 7 which wr blow < 0.4. Low loading and th low communality suggstthatitm7isunrlatdtothundrlyingconstruct bing masurd by th two factors and thrfor provids littl information on hyprsnsitivity. Finally th two factors modratly corrlatd with ach othr indicating that thy ar masuring diffrnt aspcts of hyprsnsitivity Rliability: Intrnal Consistncy. Intritm corrlations ar prsntd in Tabl 4. Th corrlations rangd from 0.06 to Itm 1 displayd xtrmly low corrlations with th rst of th itms (<0.2), particularly with itm 11 (0.06) indicating no rlationship btwn th itm contnts. Th intritm corrlations for th social subscal indicat that itms 5 and 6 ar unrlatd (<0.3) to th othr itms in th subscal indicating poor intrnal consistncy. Th rst of th itms hav low to modrat corrlation with ach othr, suggsting variability in itm contnt. Only on corrlation, btwn itm 9 and itm 10, indicats high intrnal consistncy (abov 0.7). In contrast, Cronbach s alpha stimats for th HQ global scor wr high (α = 0.88) andsubscalscorswrallabovthspcifidcritria (α > 0.7) Validity. Convrgnt validity btwn th HQ and ULLs was modrat (r = 0.535) suggsting that th two tools ar masuring diffrnt constructs with som association. Discriminant validity was as prdictd (Tabl 5). HQ scors showdmodratpositivcorrlationswiththtwomasurs of tinnitus svrity (THI and THQ) and th thr gnral halth masurs (BDI, BDI-FS, and BAI). Thrfor, with rgard to ths masurs, th HQ dmonstrats accptabl discriminant validity indicating that it masurs construct(s) that ar distinct from tinnitus spcific and mor gnral halth domains. Tabl 5: Corrlations btwn th global scors of th six qustionnair masurs. HQ THI THQ BDI-II BDI-FS BAI HQ 1 THI THQ BDI-II BDI-FS BAI Th corrlations btwn th HQ and all othr masurs wr modrat indicating accptabl discriminant validity. HQ = Hypracusis Qustionnair; THI = Tinnitus Handicap Invntory; THQ = Tinnitus Handicap Qustionnair, BDI-II = Bck s Dprssion Invntory-II, BDI-FS = Bck s Dprssion Invntory-Fast Scrn; BAI = Bck s Anxity Invntory Rsponsivnss: Floor and Ciling Effcts. Rspons frquncy distributions for ach HQ itm ar displayd in Tabl 6. Allfourtnitmsfaildtomtthaprioricritrion for accptabl floor and ciling ffcts. Twlv itms (itms 4, 12, 14, 13, 3, 2, 11, 9, 7, 1, 10, and 6) showd floor ffcts, with 17% to 71% of participants scoring 0. Itm 6 (70%), itm 10 (68%), and itm 1 (68%) had xtrm floor ffct with ovr two-thirds of participants scoring 0. Two out of th twlv itms (itms 4 and 12) that showd floor ffcts also showd mild ciling ffcts, with 17% of participants scoring 3. Th rmaining two itms (itms 8 and 5) showd ciling ffcts, with 25% and 45% of participants, scoring 3, rspctivly. Thrfor, ths rspons options ar not rliably distinguishing btwn participants and cannot b considrd rsponsiv to changs, at last in this particular population. 4. Discussion Th currnt study valuatd psychomtric proprtis of th HQ in a larg UK population of rsarch participants with

9 BioMd Rsarch Intrnational 9 Tabl 6: Rspons frquncy distributions (%) for ach Hypracusis Qustionnair itm. Frquncy of rsponss for itms (%) Man (±SD) 1 Us arplugs or armuffs to rduc nois (0.74) 2 Hardr to ignor sounds in vryday situations (0.93) 3 Troubl rading in nois (1.01) 4 Troubl concntrating in nois (0.97) 5 Difficulty listning to convrsations in nois (0.99) 6 Tolratnoisbadly (0.85) 7 Particularly snsitiv to or bothrd by nois (0.78) 8 Nois unplasant in crtain situations (1.00) 9 Think about th nois bfor going out (1.02) 10 Turn down invitation bcaus of nois (0.83) 11 Sounds bothr you mor in quit placs than noisy (0.95) 12 Strss and tird nss rduc ability to concntrat (0.98) 13 Lss abl to concntrat at nd of day (0.97) 14 Crtain sounds caus strss and irritation (0.95) Rspons frquncy distributions prsntd in bold indicat that mor than 15% of rspondnts ratd th lowst or highst possibl rspons option. All fourtn itms showd ithr floor or/and ciling ffcts (>15%). tinnitus. Dspit th high intrnal consistncy stimats, analyss did not confirm th original thr factor solution proposd by Khalfa t al. [31] for our UK rsarch population data. Larg amounts of cross-loading btwn th qustionnair itms and high corrlations btwn th factors suggstd that a on-factor solution is mor likly optimal. Howvr, a on-factor solution similarly indicatd a poor fit. Four out of 14 itms (itms 1, 5, 6, and 11) had factor loadings blow 0.4 in both modls tstd potntially suggsting that th wording of ths problmatic itms in rlation to this particular population is mor likly th caus of poor fit in th thr-factor solution. Th poor fit could at last in part b du to som population (tinnitus spcific) factors. Itm 1asks Do you vr us arplugs or armuffs to rduc your nois prcption? and although intndd to assss attntional componnt of hypracusis in a gnral population [31], within a tinnitus population using ar protction in normal nvironmnts is not ncouragd, hnc th possibility that popl with tinnitus will rfrain from using arplugs or ar muffs. Itm 6 also showd floor ffcts; it asks Has anyon you know vr told you that you tolrat nois or crtain kinds of sound badly?. Thfloorffctssninthisitmcould potntially rflct th managmnt stratgy for tinnitus such as sound thrapy and xposur to modrat lvls of background nois; in particular, tinnitus habituation thrapis (.g., tinnitus rtraining thrapy) combin ducation with sound [75, 76]. Itm 5 asks Do you hav difficulty listning to convrsations in noisy placs?. Apossiblrasonitmight not fit with th social subscal is that similar difficultis ar rportd du to haring loss and tinnitus but not ncssarily to hyprsnsitivity to sound. Finally, itm 11 asks Do noiss or particular sounds bothr you mor in a quit plac than in a slightly noisy room?. Som popl with tinnitus will us background nois to drown out or mask thir tinnitus, whil quit nvironmnt can xacrbat thir tinnitus and so gnrally tnd to avoid quit [77]. Consquntly, ths itms wr rmovd and a two-factor solution, with an attntional and social componnt with th 10 itms was idntifid using xploratory factor analysis. In trms of convrgnt and discriminant validity, modrat corrlations wr obsrvd for all masurs suggsting that th HQ is masuring an altrnativ construct to ths masurs;inparticular,thhqmasursaconstructthatis diffrnt to th snsitivity to loud sounds masurd as ULLs. Howvr, du to th diffrncs in masurs usd to tst convrgnt and discriminant validity (a psychoacoustic tst and qustionnairs, rsp.), it is hard to dfinitivly stablish th lvl of discriminant validity. To provid clarity on this, on rcommndation for futur studis is to assss convrgnt validity using a qustionnair masur of hypracusis. Itisworthnotingthatonly19outof264participants wr classifid as hypracusic according to th critrion of 28 points or mor proposd by Khalfa t al. [31]. That indicats th prvalnc of hypracusis in th UK tinnitus rsarch population of about 7.2% which is considrably lowr than prviously rportd for th tinnitus population [10, 12, 13], suggsting that th critrion scor might b too high. Th critrion scor gratr than 28 for diagnosing significant hyprsnsitivity to sound was also qustiond by Mus t al. [33],whorportdthatmostofpatintswhorportdlowr tolranc for nois and far of nois scord blow 28 on th HQ. Th HQ was dvlopd to quantify and charactris hyprsnsitivity to sound and not to b an outcom masur [31].Itis,howvr,usdasanoutcommasur[33, 40]. All itms showd floor (12 itms) or ciling ffcts (2 itms) with two itms showing xtrm floor ffcts whr ovr 60% of participants scord 0. This indicats that thos rspons options do not rliably distinguish btwn participants and would not b rsponsiv to changs in svrity in this

10 10 BioMd Rsarch Intrnational particular population. Thrfor, w conclud th 14-itm HQ is not a snsitiv masur of outcom. 5. Conclusions/Rcommndations (i)thhqdosnotprovidavalidovrallmasur of hyprsnsitivity to sound in th UK population with tinnitus. Th structur of th qustionnair was not confirmd. Until an appropriat qustionnair is dvlopd, w rcommnd th rmoval of confounding itms and valuation of a 10-itm (2-factor) vrsion of th qustionnair in a nw tinnitus and prhaps nontinnitus population. (ii) Th diagnostic critrion (28 points) nds to b rvaluatd. In ordr to stratify svrity, on suggstd mthod is through th us of anchor qustions which can provid xtrnal indicators of svrity. This stratgyhasbnusdindvlopmntofthtinnitus Functional Indx and also for idntifying maningful chang scors [78 80]. For snsitivity to sound at scrning, stratification can b basd on rspons lvls in th anchor qustion, by dirctly comparing thm to th ovrall scor on th qustionnair, providing a practical intrprtation of th scors that rflcts th patints opinions. (iii) A qustionnair masur of snsitivity to sound that is mor suitabl for us in tinnitus rsarch population should b idntifid or dvlopd. (iv) For compltnss th HQ nds to b validatd in gnral (including UK) populations, and validation should includ tst-rtst and convrgnt validity. Conflict of Intrsts Th authors dclar that thr is no conflict of intrsts rgarding th publication of this papr. Authors Contribution Kathryn Fackrll and Constanc Farnly contributd qually to this papr. Acknowldgmnts This rport is indpndnt rsarch by th National Institut for Halth Rsarch Biomdical Rsarch Unit Funding Schm. Th viws xprssd in this publication ar thos of th authors and not ncssarily thos of th NHS, th National Institut for Halth Rsarch, or th Dpartmnt of Halth. Rfrncs [1] J. A. Vrnon, Pathophysiology of tinnitus: a spcial cas hypracusis and a proposd tratmnt, Amrican Journal of Otology,vol.8,no.3,pp ,1987. [2] A. J. Klin, B. L. Armstrong, M. K. Grr, and F. R. Brown III, Hypracusis and otitis mdia in individuals with williams syndrom, JournalofSpchandHaringDisordrs, vol. 55, no. 2,pp ,1990. [3] U. Katznll and S. Sgal, Hypracusis: rviw and clinical guidlins, Otology & Nurotology, vol. 22, no. 3, pp , [4] P. J. Jastrboff and M. M. Jastrboff, Tinnitus rtraining thrapy for patints with tinnitus and dcrasd sound tolranc, Otolaryngologic Clinics of North Amrica,vol.36,no.2,pp , [5] D. M. Baguly, Hypracusis, JournalofthRoyalSocityof Mdicin,vol.96,no.12,pp ,2003. [6] A. Fabijanska, M. Rogowski, G. Bartnik t al., Epidmiology of tinnitus and hypracusis in Poland, in Procding of th Sixth Intrnational Tinnitus Sminar,J.W.P.Hazll,Ed.,pp , THC, Cambridg, UK, [7] G. Andrsson, N. Lindvall, T. Hursti, and P. Carlbring, Hyprsnsitivity to sound (hypracusis): a prvalnc study conductd via th intrnt and post, Intrnational Journal of Audiology,vol.41,no.8,pp ,2002. [8] L. Jüris,G.Andrsson,H.C.Larsn,andL.Ekslius, Cognitiv bhaviour thrapy for hypracusis: a randomizd controlld trial, Bhaviour Rsarch and Thrapy,vol.54,no.1,pp.30 37, [9] R.S.Tylr,M.Pinkowski,E.R.Roncanciotal., Arviwof hypracusis and futur dirctions. Part I. Dfinitions and manifstations, Th Amrican Journal of Audiology, vol. 23, no. 4, pp , [10] L. Jüris,G.Andrsson,H.C.Larsn,andL.Ekslius, Psychiatric comorbidity and prsonality traits in patints with hypracusis, Intrnational Journal of Audiology, vol. 52, no. 4, pp , [11] P. J. Jastrboff and J. Hazll, Tinnitus Rtraining Thrapy: Implmnting th Nurophysiological Mod, Cambridg Univrsity Prss, Cambridg, UK, [12] P. J. Jastrboff and M. M. Jastrboff, Tinnitus rtraining thrapy (TRT) as a mthod for tratmnt of tinnitus and hypracusis patints, Journal of th Amrican Acadmy of Audiology, vol. 11, no.3,pp ,2000. [13] M. Anari, A. Axlsson, A. Eliasson, and L. Magnusson, Hyprsnsitivity to sound qustionnair data, audiomtry and classification, Scandinavian Audiology, vol. 28, no. 4, pp , [14] J. Marriag and N. M. Barns, Is cntral hypracusis a symptom of 5-hydroxytryptamin (5-HT) dysfunction? Th Journal of Laryngology & Otology,vol.109,no.10,pp ,1995. [15]G.C.Thompson,A.M.Thompson,K.M.Garrtt,andB. H. Britton, Srotonin and srotonin rcptors in th cntral auditory systm, Otolaryngology Had and Nck Surgry,vol. 110, no. 1, pp , [16] P. J. Jastrboff and J. W. P. Hazll, A nurophysiological approach to tinnitus: clinical implications, British Journal of Audiology,vol.27,no.1,pp.7 17,1993. [17] R. Schatt and R. Kmptr, Dvlopmnt of tinnitus-rlatd nuronal hypractivity through homostatic plasticity aftr haring loss: a computational modl, Europan Journal of Nuroscinc,vol.23,no.11,pp ,2006. [18] A. J. Norña, An intgrativ modl of tinnitus basd on a cntral gain controlling nural snsitivity, Nuroscinc and Biobhavioral Rviws,vol.35,no.5,pp ,2011.

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