Vas Si Oncology Po

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277Volume 6, N umber 6

July /A ugust 2008 .Suppo t Oncology.n t

J Support Oncol 2008;6:277282 2008 Elsevier Inc. All rights reserved.

r e v i e w

Abstract Assessment o quality o li e (QOL) in cancer clinical trials isimportant when comparing treatments, especially when prolonged sur-vival is not expected. QOL scores may re ect physical or psychosocialunctioning or distress. The choice o QOL instrument depends uponthe defnition, research hypothesis, cancer population, depth and sen-sitivity o in ormation required, and requency o measurement. A visualanalogue scale (VAS) is commonly used to rate various subjective ex-

periences. Potential advantages o these scales include their wide scorerange and high sensitivity; disadvantages include lower completionrates than other rating scales. Single-item VASs are validated or cancerQOL, reliable, and responsive to change. These scales may best representan individuals global QOL without the constraints o predetermined do-mains. Single items are use ul or requent measurements in palliativeor advanced populations and when in ormation about domains is lessimportant. Multi-item VAS QOL instruments vary in length and domains;they are use ul in clinical trials enrolling patients with good per ormancestatus, but some are long and disease-specifc.

aluat ng sp c c th ap s should nclud thl ant ad s cts ( g, naus a/ om t ng, ha

loss, s xual unct on, ndoc n symptoms). in pa-t nts th ad anc d canc , mpo tant doma nsmay d ( g, sp tual ty, s ns o bu d n). Thl ngth, numb o qu st ons, and at ng scal allnfu nc th as o a scal s compl t on. A b nst um nt may b mo l ant n cl n cal s tua-t ons and ad anc d d s as . in s a ch, a balancmust b st uck b t n compl t n ss o n o ma-t on and sk o m ss ng data.

Subj ct xp nc s such as QOL and symp-toms can b aluat d by d nt at ng scal s,

nclud ng num cal ( g, 010), cat go cal ( g,m ld, mod at , s ), o sual ( , sual ana-logu scal ; vAS). A vAS s a l n , usually m a-su ng 10 cm, th d sc pto s at ach nd ( g,good to bad, non to s ). r spond nts placa ma k along th l n nd cat ng th subj ctxp nc . Th sco s m asu d as th d stanco th ma k om on nd o th l n . Usually, thl n do s not ha ma k ngs, o ds, o numb salong t. vASs ha b n d sc b d as s mpl ,

Manusc pt subm tt d Ma ch 29, 2007;acc pt d Ma ch 16, 2008.

Co spond nc to: D clan walsh, MSc, FACP, FrCP, D -cto , Th Ha y r. Ho tz C nt o Pall at M d c n ,

Th Cl land Cl n c Foundat on, 9500 eucl d A nu , M76,Cl land, OH 44195; t l phon : (216) 444-7793; ax: (216)445-5090; -ma l: [email protected] g

D . Haus s a r s a chF llo and D . walsh sP o sso and D ctoat Th Ha y r. Ho tzC nt o Pall atM d c n , Cl landCl n c Tauss g CancC nt , Cl land, Oh o.

Visual Analogue Scales and Assessment

o Quality o Li e in CancerKatherine Hauser, MD, and Declan Walsh, MSc, FACP, FRCP (Edin)

Qual ty-o -l (QOL) ass ssm nt s m-po tant n canc cl n cal t als, sp -c ally h n p olongat on o su al snot xp ct d ( g, th ad anc d d s aso symptomat c t atm nts). QOL m asu s mayd st ngu sh b t n t atm nts o s m la cacybut d nt t atm nt bu d n o tox c t s. QOLass ssm nt may also ha a ol n cl n cal p act c ,

nclud ng n sc n ng o phys cal and psychosoc ald st ss and aluat on o pall at t atm nt. 1

Th s no s ngl acc pt d QOL d n t on. 2 QOL s g n ally acc pt d to ncompass th holo l , nclud ng h alth; sat s act on; happ n ss;and nanc al, soc al, and n onm ntal conc ns.H alth- lat d QOL (HrQOL) s to th m-pact o lln ss o t atm nt on QOL. H alth- lat dQOL s mult d m ns onal ( nclud ng phys cal, psy-cholog cal, soc al, and unct onal doma ns). 2,3 QOLmay also b d n d by th nd dual. Th gap th -o y d n s QOL as th gap b t n an nd dualsxp ctat on o l and h s o h al ty. 4 P opl npoo h alth may d sc b good QOL b caus thxp nc m ts xp ctat ons. Doma ns such asam ly, lat onsh ps, sp tual ty, s ns o cont ol,and autonomy may b mo mpo tant to pat ntsthan a phys cal xp nc s. 5

Assessing QOLTh s no gold standa d o QOL ass ssm nt.

Th cho c o nst um nt s nfu nc d by th s t-uat on (cl n cal o s a ch), th stag o d s as( a ly, ad anc d, su o ), and th t atm nt(cu at , pall at ). Canc stag and t atm nt

nfu nc l ant doma ns. QOL nst um nts o


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278 .Suppo t Oncology.n t t he JourNAl of s upportiVe o Ncology

vASs ha sho n mp o d QOL th pa n l , 15,16 stablQOL n pat nts n hosp c ca , 17 and spons to st uctu dnt nt on du ng ad oth apy. 18

On ssu th s ngl - t m vASs s h th a mult d -m ns onal conc pt l k QOL can b captu d n a s ngl l n .S ngl - t m scal s do not aluat th doma ns cont but ngto QOL and thus p o d no n o mat on xpla n ng th o -all at ng. Ho , many mult d m ns onal nst um nts lyon xp ts to d t m n doma ns and th ght ng; th ymay not t uly p s nt doma ns mpo tant to an nd dual.S ngl - t m scal s l a th d n t on o QOL to th nd -dual spond nt.

in hosp c ca , s ngl - t m QOL co lat d ll th cog-n t , phys cal, and sp tual ll-b ng and soc al act ty butnot th soc al suppo t. 18 S m la ly, th eOrTC (eu op anO gan zat on o r s a ch and T atm nt o Canc ) QLQ-C30 (Qual ty-o -L Qu st onna Co 30) global QOLsubscal (num cal) co lat d mod at ly th phys cal, ol ,cogn t , mot onal, and soc al unct on ng; at gu ; and pa ndoma ns but l ss th naus a and om t ng. 19 Th m an ng

o th t m QOL may a y by ag , cultu , ducat on, andlanguag . Global nd cato s ( g, t atm nt bu d n) may alloa compa son b t n d nt t atm nts ac oss t als. 20,21

The Spitzer Uniscale.Th Sp tz Un scal s a s ngl qu s-t on: Pl as at you o all QOL. 22,23 O g nally d s gn do phys c an at ng, t s no us d o both pat nt and obsQOL at ngs. 23 Th Sp tz Un scal s al d, th mod at toh gh co lat ons th mult d m ns onal QOL m asu s; t ss ns t to chang s n p o manc status, symptoms, and p o-g ss d s as and co lat s th su al. 23 Phys c an sco sag mod at ly th pat nts sco s, although th y t nd tound st mat QOL. Th compl t on at s abo 90%.

r spond nts ma k an X n a box th ancho s lo stqual ty to h gh st qual ty. Th o g nal Un scal d sc pt ond d not sp c y th l ngth o th box, no h on th X thsco as m asu d. Sco ng has b n d sc b d as th 014o 0100. Som autho s adapt d t to a s ngl -l n vAS thth sam ancho s.

MULTI-ITEM VASS FOR QOL

Mult pl - t m vASs o canc QOL st d sc b d n1976.7 T n ho zontal vASs ass ss d phys cal and psycholog -cal symptoms, act ty, soc al and ol act t s, and ll-b -ng. Sco s spons to t atm nt and tox c ty. S almult d m ns onal vAS QOL nst um nts ha b t n 8 and

53 t ms. Th y may b g n al ( g, GLQ824

) o d s as -sp c c(Lung Canc Symptom Scal [LCSS] 25,26 o th P ostat Can-c Sp c c QOL inst um nt [PrOSQOLi]). 2729 Althoughdoma ns a y, th y all ass ss pa n and app t t but l ss o t nnaus a and at gu . Many a l ngthy, l m t ng th us uln ssto cl n cal t als, and a not l ant o ad anc d canc opall at populat ons. Compl t on at s a n qu ntly -po t d. wh n po t d, th y a h gh (80%90%). 24,30 Fam lys mpo tant n th QOL o canc pat nts but n qu ntlyass ss d. S m la ly, sp tual ty s ass ss d n only on mult -

h ghly s ns t , and l abl at ng scal s o subj ct x-p nc s. 6 Th ma n ad antag o a vAS s that spond ntsmay nd cat any plac along th l n ath than b st ct dby cat go s o numb s.

vASs ha b n us d to ass ss canc QOL s nc 1976. 7 Th s a t cl a ms to th ol o vASs n th aluat ono canc QOL and th m thodolog c ssu s assoc at d thth us .

VASs for QOL of Cancer PatientsvASs o QOL o canc pat nts may b s ngl - t m, global

qu st ons ( g, ho s you QOL?) o mult - t m scal s. Mult -t m scal s nclud nd dual qu st ons about many doma ns o QOL ( g, symptoms, unct on, lat onsh ps) and may also n-clud a global scal . Th s scal s o t n ha a summat d scop s nt ng o all QOL and may ha s al subscal sco s.

S ngl - t m vASs o QOL ha b n sugg st d to b st p -s nt nd dual QOL b caus th y do not const a n spons s toth doma ns d t m n d by h alth ca p o d s. 5

SINGLE-ITEM VASs FOR QOL

S al s ngl - t m vASs o QOL ha b n al dat dn oncology. Th y a y n d s gn (F gu 1), th d sc pto snclud ng g n al ll-b ng, 8 l not o th l ng, 9 phys calll-b ng, 10 cop ng, 11 and QOL. 12,13 S ngl - t m QOL vASs

co lat ll th mult d m ns onal qu st onna s. 8,9,1114 T st- t st 8,12 and nt at 13 l ab l ty ha also b n d m-onst at d. vASs a spons to ch moth apy- lat dchang s o t m and global at ngs o chang . 10,12 S ngl - t m

Visual Analogue Scales and Assessment of Quality of Life in Cancer

Life is not worth living

Life could not be better

Worst imaginablequality of life

Perfectquality of life

How are you doing overall today?Worst possible Best possible

How would you rate your well-being today?Very low Very high

How would you rate your quality of li fe today?Very low Very high

Figure 1 Examples o Global Quality-o -Li eVisual Analogue Scale


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d m ns onal qu st onna (th QOL-rTi [QOL-rad at on

Th apy inst um nt], h ch has subs qu ntly chang d to anum cal o mat). 31 General scales. G n al vAS nst um nts a d sc b d n

Tabl 1. 7,2426,2840 Many nclud a s ngl - t m o all QOLscal o a summat d sco .

Lung cancer. Th s l - po t d LCSS has s x symptom (ap-p t t loss, cough, dyspn a, at gu , h moptys s, pa n) and thsumma y scal s (symptom d st ss, no mal act ty, and o allQOL). 25,26,39,40 An obs scal at s th s x symptoms on o -d nal scal s. it s ll al dat d by co lat ons th oth n-

st um nts and p o manc status and has nt nal cons st ncy

as ll as t st- t st and nt at l ab l ty. r spons n sshas not b n t st d. Num cal and m soth l oma scal s hab n al dat d. 41,42 Th m an compl t on t m s 8 m nut s opat nts and 2 m nut s o obs s. Th LCSS f ct d thb n t o doc tax l (Taxot ) ch moth apy o no lb no b st suppo t ca n ad anc d lung canc 43,44 and b t-t QOL n non smok s. 45 Th app t t and at gu subscal snd p nd ntly p d ct su al. 46 Th LCSS s comput z d ohand-h ld d c s, s asy to us , and s abl to nhanc com-mun cat on and sat s act on th cl n c s ts. 47

Hauser and Walsh

Table 1

Multi-item Quality-o -Li e Visual Analogue ScaleAUTHOR ORINSTRUMENT DESIGN DOMAINS PSYCHOMETRICS

Priestman and Baum 7,32 10 horizontal VASs Well-being, mood, activity, pain, nausea, Responsive to change with chemotherapy,(1976, 1983) appetite, housework, social activities, endocrine therapy

anxiety, treatment response Test-retest reliability at 24 hours

Padilla et al33

14 horizontal VASs General physical condition (pain, appetite, Discriminates inpatient/outpatient,(1983) nausea, strength) analgesic useImportant activities Internal consistencyOverall QOL Test-retest reliability

Selby et al 3436 29 horizontal VASs 5- actor structure: physical activities, Correlations with SIP, KPS(1984, 1988, 1992) emotional, alimentary, appearance, Discriminates metastatic disease/early,

and concentration and language chemotherapy or notInternal consistency Test-retest reliability at 912 hoursInterrater reliability

Holmes and Dickerson 37 26 horizontal VASs Symptoms, 11 items Discriminates inpatient vs outpatient(1987) Activities o daily living, 15 items Internal reliability

Test-retest reliability at 1 hourCoates et al 8 horizontal VASs Physical symptoms: pain, atigue, Correlations with FLIC, PACIS, PACGLQ824 appetite/sense o taste, nausea/vomiting, Discriminates chemotherapy and

(1990) hair loss numbness/pins and needles per ormance statusAnxiety, depression, sexual interest Test-retest reliability at 1 and 24 hours Thought o having treatmentGlobal QOL

Ballatori et al 38 49 items, 10 cm horizontal 3 actors: psychological, relationship to Discriminates per ormance status

(1993) VASs hospital, and appetite Test-retest reliability at 24 hoursHollen et al Patient scale: 9 horizontal 6 symptoms: appeti te loss, cough, dyspnea, Correlates with KPS, SIP, POMSLCSS25,26,39,40 VASs atigue, hemoptysis, pain Discriminates per ormance status, cancer(1993, 1994, 1999) Observer scale: 6 symptoms 3 summary scales: symptom distress, stage

(ordinal scale) normal activity, and overall QOL Internal reliabilityEach item on a separate card Test-retest reliability at 1 hour

Modifed and validated or mesothelioma 41 Numerical orm validated 42

Johnson et al 24 horizontal VASs 4 domains: unctional/health, Correlates with FPQLIQOL-RTI31 socioeconomic/ amily, general QOL, Internal consistency

(1994) emotional/psychological Test-retest reliability at 1 week Subsequently, scaling changed to

numerical 010, and head and neck module added

Tannock et al, 9 horizontal VASs Physical symptoms (appetite, constipation, Correlates with EORTC QLQ-C30Stockler et al atigue, pain, passing urine, physical Discriminates per ormance status,PROSQOLI2830 activity), mood, amily, and global hemoglobin level, analgesic score, and(1996, 1998, 1999) well-being survival

Responsive to treatment

Abbreviations: EORTC QLQ-C30 = European Organization or Research and Treatment o Cancer Quality-o -Li e Questionnaire C30; FLIC = Functional Living IndexCancer; FPQLI = Ferrans andPowers Quality o Li e Index; KPS = K arno sky Per ormance Status; LCSS = Lung Cancer Symptom Scale; PAC = Psychological Adjustment to Cancer Scale; PACIS = Perceived Adjustment to ChronicIllness Scale; POMS = Profle o Mood States; PROSQOLI = Prostate Cancer Specifc Quality o Li e Instrument; QOL = quality o li e; QOL-RTI = Quality o Li e-Radiation Therapy Instrument; SIP =Sickness Impact Profle; VAS = visual analogue scale


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At th s t m , ho , only th LCSS has po t d sults than l ct on c s on. 47

Cons nsus s lack ng about th stat st cal analys s o vASdata. 59,60 issu s n ol h th th data a o d nal o at oand h th sco s a no mally d st but d and thus appl -cabl o pa am t c analys s. Compa son o pa am t c ( thand thout t ans o mat on) and nonpa am t c analys s o vAS pa n sco s sugg st d that pa am t c t sts accu-at and had th g at st po to d t ct a d nc , d sp ta lack o no mal d st but on o th data. 61

COMPLETION RATES

Compl t on o a vAS qu s conc ptual zat on o a com-pl x xp nc to a s ngl l n . vAS pa n scal s ha locompl t on at s than num cal o cat go cal scal s. 62,63 rat s a ad s ly a ct d by nc as ng ag , h gh op o ddos , and th p s nc o con us on. 62,63 Ta n ng n vAS t ch-n qu s mo t m -consum ng than o oth at ng scal s. 64 in QOL stud s, th Un scal has a s m la compl t on at tooth mult - t m nst um nts. 23 Both th PrOSQOLi 28 and

LCSS43

ha h gh compl t on at s (> 80%) n cl n cal t als.Th eSAS compl t on at d cl n s th ad anc ng d s as .

SENSITIVITY

vASs a sa d to b mo s ns t to subj ct chang sthan a num cal o cat go cal scal s. Ho , t s uncl ah th such h gh s ns t ty s cl n cally l ant. Stud s o QOL n ca d ac and sp ato y a lu ha d monst at da 7-po nt bal d sc pto scal had qual s ns t ty to avAS. 64,65 val dat on o a 010 num cal LCSS d monst at-d good ag m nt th a vAS. 42 Compa son o a vAS nth PrOSQOLi th qu al nt L k t scal s o th eOrTCQLQ-C30 d monst at d sup o s ns t ty o th vAS opa n and oth phys cal symptoms. 28 All scal s d nt at dt atm nt g oups, but th vAS as l ss s ns t n compl xdoma ns l k am ly and mot onal unct on.

CLINICAL SIGNIFICANCE

Small chang s on a vAS ( g, 05 mm) may b stat st callys gn cant but cl n cally l ant. Th cl n cal s gn canccan b aluat d by compa ng vAS sco s th a globalchang scal ( g, om much b tt to much o s ). Fo acutpa n, th m n mal cl n cally s gn cant vAS chang s 13mm.66 ind ct LCSS analys s suppo t d cl n cally s gn cantchang s o 1025 mm. 67 Cl n cally s gn cant chang has b n

sugg st d as 50% o th scal s standa d d at on ( , 810mm on a 100-mm vAS). 21 Th s sult ould b qu al nt toa chang o 1 on an 11-po nt num cal scal .

Instrument SelectionS al acto s a ct th s l ct on o an nst um nt. Popu-

lat on cha act st cs ( nclud ng ag , d agnos s, and p o -manc status) a ct compl t on at s and h th a d s as -sp c c o g n al qu st onna s app op at . in s a ch,th d n t on and hypoth s s nfu nc th s cho c , pa t cu-

Prostate cancer. Th PrOSQOLi has n n vASs ass ss-ng phys cal symptoms (app t t , const pat on, at gu , pa n,pass ng u n , phys cal act ty), mood, am ly, and globalll-b ng. 29,30 it ms co lat mod at ly th th eOrTC

QLQ-C30. it d sc m nat s pat nts by p o manc status,h moglob n l l, analg s c sco , and su al. it has d mon-st at d mp o d o all QOL n ad anc d ho mon - ac-to y p ostat canc pat nts ho spond d to m toxant onand p dn solon . 30

PROXY MEASURES OF QOL

A vAS may also b us d to aluat sp c c doma ns o QOL ( g, nd dual symptoms o psycholog cal conc ns).

Single-item VASs.S ngl - t m vASs a al d o ass ssm nto pa n and d p ss on n canc . 48,49 Th y a us ul n cl n calt als h n chang n nd dual symptoms s xp ct d. Th ymay b pa d th a s ngl - t m QOL scal to n st gat thmpact o symptoms on o all QOL. 15

Edmonton Symptom Assessment Scale (ESAS). Th eSASas d s gn d o pall at populat ons. N n vASs aluat

symptoms (act ty, anx ty, app t t , d p ss on, d o s n ss,pa n, naus a, sho tn ss o b ath, and ll-b ng); sco s asummat d to a d st ss sco . 50 it s al d th nt nal cons s-t ncy and t st- t st l ab l ty. 51 int at stud s al ano st mat on o symptoms by ca g s and an und st -mat on o symptoms by phys c ans. 50,52 Th compl t on at sa y by stag o d s as . Most g n al oncology pat nts cancompl t t on hosp tal adm ss on, compa d th 63%84%o pall at m d c n canc pat nts and only 15% o t -m nal pat nts. 50,51,53 rout n us o eSAS on adm ss on to apall at m d c n un t has sho n s gn cant und ass ss-m nt and docum ntat on o symptoms, sp c ally nact ty,mpa d ll-b ng, and anx ty. 54

The Distress Thermometer. Th D st ss Th mom t s amod d vAS: a t cal th mom t numb d 010 thth o ds no d st ss, mod at d st ss, and s d st ssalong th scal . 5557 it has a 34- t m p obl m ch ckl st, n-clud ng phys cal and psychosoc al conc ns. it s al dat dn canc populat ons and ad ocat d o out n sc n ng. 58 Sco s o at l ast 4 a comm nd d as th t gg o u thaluat on and nt nt on. Th s no d nc as to th

assoc at on b t n D st ss Th mom t sco s and QOLo cl n cal outcom s om out n sc n ng.

Methodologic Issues

Many stud s al dat ng QOL nst um nts a con n nco cl n cal t al sampl s. Th s act pot nt ally l m ts th l-anc o th s nst um nts to s l ct d populat ons. Oth

m thodolog c ssu s nclud th pot nt al o m asu m nto and th unsu tab l ty o t l phon ollo -up. Sco ng

a vAS qu s m asu m nt ath than s mply ad ng oma pap , pot nt ally add ng a sou c o o . vAS qu st on-na s must b p nt d nd dually, as photocopy ng can d s-to t th l ngth o th l n , l ad ng to ncons st nt sco ng. AvAS can b comput z d, th by a o d ng such d cult s.



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la ly h th global QOL o sp c c doma ns a mpo tanto l k ly to chang th nt nt on.

Th cho c o scal (vAS, num cal, o cat go cal) d -p nds upon th data s ns t ty qu d and th d s dcompl t on at s. inst um nts that app a to b l ant tocl n cal p act c nclud s ngl - t m global scal s (QOL, t at-m nt bu d n), th eSAS, th D st ss Th mom t , and thLCSS. inst um nts th num cal o cat go cal scal s mayb as to compl t and sco , and chang s may b mol ant to cl n cal p act c . M asu m nt qu ncy s mpo -

tant; s ngl - t m vASs may b us ul o qu nt m asu sand may a o d pat nt bu d n. S ngl - t m QOL nst um ntsmay b o th h l n cl n cal t als ( sp c ally long tud nalon s) o cl n cal sc n ng (pa n, d p ss on, ad anc d can-c ) and o global QOL. 13 in symptom l t als, comb n ngsymptom and s ngl - t m QOL vASs ass ss s th mpact o symptoms on QOL. S ngl t ms a l ant and may b stp s nt hat th pat nt s xp nc ng. wh th th scoang 0100 s n c ssa y s d batabl ; p haps a sco ang o only 010 s n d d.

Future ResearchCla cat on o th d al at ng scal s o QOL s n c s-

sa y. D lopm nt and us o pat nt- ocus d nst um ntsmay balanc th bu d n on spond nts and cl n cally l-ant data. Compl t on at s n d to b docum nt d n

uns l ct d cl n cal populat ons. Cl n cally s gn cant cuto po nts and sco d nc s should b d t m n d o globaland mult - t m nst um nts. in add t on, n o mat on aboutth most app op at QOL nst um nts o cl n cal p act cand d nc o mp o d outcom s as a sult o th ou-t n us a n c ssa y.

ConclusionS ngl - t m QOL vASs ac l tat an nd dual d n -

t on o QOL and a us ul n ad anc d o pall at pop-ulat ons and long tud nal stud s. Th y a s ns t andspons to chang th t m and t atm nt. Mult - t m

vAS nst um nts a o t n l ngthy and d s as -sp c c;th y a us ul n s a ch stud s, g n pat nts haa good p o manc status. vASs a mo d cult tocompl t than a oth at ng scal s and ha th po-t nt al o m asu m nt o . Th vAS sco ang may

not t anslat nto cl n cal s gn canc . Fu th s a ch sn d d to d t m n h th QOL vASs a app op ato cl n cal p act c .

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