Scand J Rheumatol 2002;31:6–12

Measuring health related quality of life in patients with rheumatoidarthritis ± reliability, validity, and responsiveness of a Swedishversion of RAQoL

KerstinEberhardt, Siv Duckberg, Britt-Marie Larsson, Pia MalcusJohnson, andKerstinNived

Department of Rheumatology, Lund University Hospital, Lund, Sweden

Objective: To adapt the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire for Swedish patients and evaluate psychometricproperties in a prospective study.Methods: Reliability was assessed in 61 patients � lling in RAQoL two times with one week’s interval. 114 patients completed RAQoL andNottingham Health Pro� le (NHP) on 2–3 occasions 6 months apart. Validity was evaluated comparing RAQoL-scores to disease-relatedvariables and NHP subscales. Standardized response mean was applied to calculate responsiveness with the RA-related variables as externalindicators of change.Results: Test-retest reliability was high and internal consistency suYcient. RAQoL correlated as expected to NHP section scores. In amultivariate model the Stanford Health Assessment Questionnaire disability index (HAQ) and general health could explain 40% anddisease activity measures 13% of the variance of RAQoL. Correlations between change scores of clinical variables and RAQoL and NHPwere weak but positive. Standardized response means regarding change of disease activity, HAQ, and general health were small but in thesame range for both RAQoL and NHP.Conclusion: The Swedish RAQoL had similar measurement properties as the original version. However, responsiveness regarding conditionspeci� c measures was not better than for the generic instrument NHP.

Key words: rheumatoid arthritis, quality of life, health status, RAQoL, Nottingham Health Pro� le, responsiveness

Rheumatoid arthritis (RA) is a chronic disease with disease. There might therefore also be a need forcondition speci� c HQOL instruments. A HQOLoverall impact on patients ¢ lives. Assessment of out-

come and treatment eVects should therefore if pos- measure for patients with rheumatoid arthritis(RAQoL) was recently developed. It has shownsible not only include diVerent medical aspects but

also an evaluation of health related quality of life suYcient reliability and validity (9) and also somepreliminary evidence of sensitivity to change (10).(HQOL). According to the WHO de� nition QOL is

the perception of individuals of their own position in The aim of this study was to translate RAQoLinto Swedish and assess its measurement propertieslife in context of the culture and value system in

which they live, and in relation to their goals, expecta- in a group of RA-patients followed prospectively. Wealso wanted to compare responsiveness of RAQoLtions, standards, and concerns. HQOL pertains the

physical, emotional and social aspects of QOL in� u- and the generic measure NHP.enced by an individual’s disease and/or its treatment(1). There are a wide variety of instruments intendedto evaluate HQOL. Instruments that are termed Patientsandmethodsgeneric have been designed to assess HQOL across

Patientsthe full spectrum of health problems. Examples ofgeneric instruments which have been applied in The whole study group comprised 114 RA patientsRA-patients are Short form 36 (SF-36) (2,3), (38 men and 76 women) with a mean (SD) age of 60Nottingham Health Pro� le (NHP) (4,5) and Euroqol (11.6) years and mean (SD) disease duration of 10(6,7). None of these instruments has been proven (4) years. All patients had de� nite RA (11). Theybetter than the others, and all have diVerent participated in an observational prospective study aslimitations (8). previously described (12).

Generic instrument may overlook some aspects ofhealth that are important for patients with a certain

Clinical assessments

Kerstin Eberhardt, Department of Rheumatology, Lund The patients were assessed at an out patient teamUniversity Hospital, Lund, SE-221 85 Lund, Sweden. E-mail: care unit every 6 months. Joint in� ammation waskerstin.eberhardt@reum.lu.se

evaluated by an active joint count. A joint wasconsidered active if swollen and either tender orReceived 10 August 2001

Accepted 5 December 2001 painful at motion. The 50 joints evaluated included

6 © 2002 Taylor & Francis on license from Scandinavian Rheumatology Research Foundation

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Responsivenessall but two from the Ritchie index (13) namely theneck and subtalar joints.

All 114 patients � lled in RAQoL and NHP at studyDisability was assessed with a Swedish version of

start and after 6 months. Sixty-two of the patientsHAQ (14).

also completed the 2 tests after 1 year. The changeThe patients assessed their general health on a

scores of all test results, both between 0 and 6 months100-mm horizontal visual analogue scale (VAS). In

and between 6 and 12 months (114 + 62 =176) wereorder to facilitate the comparison with the HAQ

pooled together in the analyses of responsiveness.scores, the VAS value in mms was multiplied by 3and then divided by 100, thus giving a range of 0–3.

Statistical analyses

RAQoL Correlations were evaluated by the Spearman Rankcorrelation coeYcient method.

RAQoL is a self-administered test consisting of 30Factor analysis of the RAQoL items applying the

simple statements. The patient should consider if atprincipal component analysis with varimax rotation

the present situation each statement � ts his or herwas performed. Eigenvalues above 1 were used as

own experience or not.break criteria.

Multiple regression analyses with RAQoL or NHPTranslationprocedure scores as dependent variable and clinical and laborat-

ory variables as independent ones were performed.Two independent authorised translators translated

We used a hierarchical procedure entering diseasethe English version of the RAQoL instrument into

activity variables (active joint count and ESR) as aSwedish. The two versions were joined into one by

� rst block and general health and HAQ as a secondthe authors taking conceptual problems in considera-

block.tion. The thus obtained Swedish version was then

Standardized response mean e.g. mean change/re-translated into English by a third authorised trans-

standard deviation of change was used to evaluatelator. This was done to control that no essential

the responsiveness (17). Standardized response meaninformation in the English version had been lost.

was classi� ed as small (> 0.2), medium (> 0.5) orA small � eld test comprising 10 RA-patients was

large (> 0.8) (18 ). Active joint count, ESR, HAQ,performed to assure that all statements were easily

and general health were all used as external indicatorsunderstood.

of change in disease status.

ReliabilityResults

Test-retest reliability.The Swedish version of RAQoL is displayed in

This part of the study comprised the 61 patientsappendix 1.

who attended the clinic during the � rst month of theThe patients found it easy to understand and

study. The patients � lled in the RAQoL form at 2complete. It took them 5–6 minutes to � ll in the

occasions with one week’s interval. The � rst test wastest form.

completed at the clinic visit and the second testFigure 1 shows the percentage of patients who

at the patient’s home.Internal consistency of the items included in

RAQoL was evaluated with Crohnbach’s alpha.

Validity

RAQoL was compared to the generic HQOL instru-ment, NHP. This test is also self-administered andcomprises 48 statements (answered yes or no)assessing physical mobility (8 items), pain (8 items),sleep (5 items), emotional reactions (9 items), socialisolation (5 items), and energy level (3 items). Scoringwas made with item weights obtained in a Swedishpopulation (15,16). The RAQoL scores were relatedto the diVerent NHP section scores. Fig. 1. Percentage of patients experiencing that the RAQoL state-

Associations between RAQoL and the diVerent ments � tted their present illness situation. Total number of patientswas 114.clinical and laboratory variables were also evaluated.

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TableI. Correlations between RAQoL scores and the different NHPfound that the statements applied to them. Item 14section scales. All correlations are significant at the 0.001 level.concerning physical mobility and item 3 concerning

problems in � nding comfortable shoes showed the NHP-scales Rshighest frequency of positive answers.

Physical mobility 0.77Correlations between the original items of RAQoLEnergy level 0.71were in general weak, none exceeding 0.6. DespitePain 0.72this we performed a factor analysis to investigate theEmotional reactions 0.68

possible underlying dimensions of RAQoL. As seen Social isolation 0.48from the scree plot (Fig 2) at most 2 useful factors Sleep 0.38could be identi� ed: one mainly concerning psycholo-gical problems (factor 1) and one mainly concerningdisability (factor 2). Items with the strongest rotated Table III a displays the relation between RAQoL,

NHP and the clinical variables at baseline andloadings for factor 1 were items 16 (I often getdepressed) and 27(I � nd it diYcult to take care of table III b shows the same, but for the change scores.

At baseline correlations to disability and generalthe people I am close to) and for factor 2 items 7(Jobs about the house take me a long time) and 14 health were stronger than those to disease activity

measures. The correlation between RAQoL and NHP(I � nd it diYcult to walk very far). However only34% of the variance of the RAQoL scores could be was Rs =0.81. All correlations to change scores were

weak with no distinct diVerences between RAQoLexplained by the two factors. We therefore continuedthe evaluation of RAQoL with all the original items and NHP. The correlation between the change scores

of the two HQOL instruments was Rs =0.70.included in a total score.

All the 61 patients in the reliability study completed The regression models obtained with RAQoL orNHP as dependent variable and clinical and laborat-RAQoL at both occasions. Scores at study start was

mean (SD) 9.4 (6.3) and one week later 9.5 (6.3). ory variables as independent ones are displayed inTable IV a and b. The complete models could explainTest-retest reliability was Rs = 0.92.

Crohnbach’s alpha coeYcient was 0.89. 53% of the variance of RAQoL and 54% of thevariance of NHP. The contribution of disease activityTable I display correlations between RAQoL and

the diVerent NHP section scores. All correlations variables was small (13% for RAQoL and 9% forNHP).were signi� cant but physical mobility, pain, and

energy level showed the strongest correlations. The Table V a and b shows standardized responsemeans for RAQoL and NHP. The smallest changescorrelation between NHP physical and HAQ was

Rs = 0.73. necessary for de� nition of improvement and deteri-

oration were set at ± 2 and + 2 for active joint count,Table II shows baseline values and change scoresfor the clinical and laboratory variables and RAQoL ± 2 and + 10 for ESR, ± 0.2 and + 0.2 for HAQ,

and ± 0.4 and + 0.5 for general health. These wereand NHP. The majority of patients had low diseaseactivity and fairly stable disease over time. limit values for the change scores of the diVerent

variables for the 25% of our patients doing best andworst, respectively. The only exception was improve-ment of HAQ, where this value was increased from± 0.1 to ± 0.2, as ± 0.1 was a too small change todetect. The number of patients with improvementof the HAQ-score of ± 0.2 or more was 38.Responsiveness for change of the diVerent variableswas similar for RAQoL and NHP. All standardizedresponse means were classi� ed as small.

Discussion

There is an increasing awareness of the importanceto assess HQOL both in studies of treatment eVectsand in longitudinal observational studies. The prere-quisite for this is of course reliable, valid and sensitivemeasurement tools. The great advantage of genericinstruments is that overall health status of patientswith diVerent diseases can be compared for instanceFig. 2. Scree plot of the eigenvalues obtained in the factor analysis

plotted against their associated component. at resource allocation. However, they may not capture

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Table II. Baseline values and change scores for some clinical and laboratory measures and the 2 HQOL-instruments in 114 RA-patients evaluated2± 3 times during one year.

Baseline mean (SD) Baseline range Mean change (SD) Change range

Active joint count (0± 50) 3.5(4.5) 0± 22 0.4(4.8) ±22± 16ESRmm/h 24.1 (21.1) 2± 96 8.3 (19.0) ±46± 66HAQ(0± 3) 1.1(0.68) 0± 2.9 0(0.4) ±1.5± 1.3General health (0± 3) 1.3(0.7) 0± 3 0 (0.7) ±2.7± 2.2RAQoL(0± 30) 9.7(6.6) 0± 27 0.4(4.5) ±18± 12NHP(0± 100) 24.7 (19.8) 0± 74 1.4(15.9) ±55.7± 42.9

Table III. Correlations between RAQoL and NHP and clinical and TableV. Standardized response means for RAQoL for improvementanddeteriorationof thedifferent clinical andlaboratory measures overlaboratory variables at baseline (114tests).6± 12 months. Limit values for improvement and deterioration were:a) active joint count ±2 and +2, ESR ±2 and +10, HAQ ±0.2 and+0.2, and general health ±0.4and +0.5.RAQoL NHP

Rs Rs a)

Improvement DeteriorationActive joint count 0.33*** 0.34***ESR 0.30** 0.17HAQ 0.67*** 0.57*** Active joint count ±0.2 0.2

ESR ±0.1 0.2General health 0.50*** 0.51***HAQ ±0.3 0.2General health ±0.2 0.4b)Same as a)but for change scores over time (176 tests)

RAQoL NHP b)Same as a)but for NHPRs Rs

Improvement DeteriorationActive joint count 0.16* 0.20**ESR 0.13 0.10 Active joint count ±0.2 0.3

ESR ±0.1 0.2HAQ 0.20* 0.22**General health 0.18* 0.19* HAQ ±0.4 0.3

General health ±0.2 0.3*p<0.05.**p<0.01.***p<0.001.

clinically relevant disease-speci� c changes for instancein clinical trials.

Reliability and validity testing of our SwedishTable IV. Multipleregressionmodel for RAQoLatbaseline. Thediseaseversion of RAQoL showed that it had measurementactivity variables active joint count and ESR were entered as a first

block and HAQ and general health were entered as a second block. properties similar to the original test (9). It was easyTotal R2=0.53(1st block0.13and 2nd block0.40). and quick to apply and the patients found the ques-

tions relevant. This is re� ected in Fig. 1 showing thata)all statements did at least to some degree � t into the

Partial R Beta p-value patient’s experiences of their illness situation. Thetest-retest reliability was high and internal consistency

Active joint count 0.11 0.08 0.31suYcient. No useful factor analytic solution could beESR 0.19 0.14 0.07obtained. Depression and physical limitation wereHAQ 0.54 0.49 0.00

General health 0.38 0.30 0.00 the two strongest underlying dimensions of the test.However, only one third of the variance of RAQoL

b)Same as a)but for NHP was explained by these factors and the test wasTotal R2=0.54(1st block0.09, 2nd block0.45) therefore in this study applied with all the 30 items

included in the same way as was done in the originalPartial R Beta p-valuepublication (9).

Active joint count 0.13 0.10 0.26 Correlations between RAQoL and the diVerentESR 0.04 0.03 0.74 NHP section scores were in the same range as for theHAQ 0.50 0.48 0.00 English version. Dimensions related to symptoms ofGeneral health 0.33 0.29 0.00

muscle skeletal disease showed strongest relation to

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RAQoL while other aspects of quality of life were Taking these advantages into account, most informa-tion regarding HQOL in RA-patients will probablypartly lost.

The univariate correlations between RAQoL scores be obtained by applying a generic instrument. Adisease speci� c measure of disability should also beand the measures of disease activity were weak and

in the multivariate analyses these measures did not added to the assessment procedure.To conclude: the Swedish version of RAQoL wascontribute to more than 13% of the explanation of

the variance of the RAQoL scores. The measures of reliable, valid and sensitive to small changes of diseasestatus. However, psychometric properties were similardisability and general health contributed more and

HAQ was the strongest explanatory factor both for to the generic HQOL measure NHP.RAQoL and NHP. However, taken together onlyabout half of the variance could be explained, show- Acknowledgementing that HQOL is a complex interaction with many

Grants were obtained from the Medical Faculty of Lund, Theother factors such as for instance individual belief,Osterlund and Kock Foundations, The King Gustaf V 80-yearattitude and social adjustment.Fund, and Reumatikerforbundet.The strong in� uence of physical limitation for

HQOL in RA-patients was of course to be expectedReferencesbut stresses the importance of adequate measurement

of disability. In this study, although relations between1. Strand V, Russell A. WHO/ILAR task force on quality of

HAQ, RAQoL and NHP physical were rather strong, life. J Rheumatol 1997;24:1630 –3.not all aspects of condition speci� c disability could 2. Stewart A, Hays R, Ware J. The MOS short form general

health survey: Reliability and validity in a patient population.be captured by the 2 HQOL instruments.Med Care 1988;26:724 –35.The longitudinal study design gave an opportunity

3. Tuttleman M, Pillemer S, Tilley B, Fowler S, Buckley L,to evaluate and compare the sensitivity to change forAlarcon G, et al. A cross sectional assessment of health status

the disease speci� c and the generic instrument. We instruments in patients with rheumatoid arthritis participatingcould show weak but positive correlations between in a clinical trial. J Rheumatol 1997;24:1910 –5.

4. Hunt S, McEwan J, McKenna S. Measuring health status.change scores of the clinical variables and bothLondon: Croom Helm, 1986.RAQoL and NHP. One statistical approach for fur-

5. Houssien DA, McKenna SP, Scott DL. The Nottinghamther measurement of responsiveness is calculation ofhealth pro� le as a measure of disease activity and outcome in

the standardized response mean, which compares the rheumatoid arthritis. Br J Rheumatol 1997;36:69 –73.magnitude of change with the standard deviation of 6. EuroQol Group. EuroQol – a new facility for the measurement

of health-related quality of life. Health Policy 1990;16:199 –208.that change (17 ). For these calculations all clinical7. Hurst NP, Kind P, Ruta D, Hunter M, Stubbings A.and laboratory measures were used as external indic-

Measuring health-related quality of life in rheumatoid arthritis:ators of change. A methodological concern was thatvalidity, responsiveness, and reliability of EuroQol (EQ-5D).

many patients had low disease activity and stable Br J Rheumatol 1997;36:551 –9.disease course over time. To try to some extent to 8. Whalley D, McKenna SP, de Jong Z, van der Heijde D.

Quality of life in rheumatoid arthritis. Br J Rheumatolovercome this we used the data for the one fourth of1997;36:884 –8.the patients doing best and worst, respectively, but

9. De Jong Z, van der Heijde D, McKenna SP, Whalley D. Thethe limit values for detection of improvement andreliability and construct validity of the RAQoL: a rheumatoid

deterioration were still small. Despite this, both arthritis-speci� c quality of life instrument. Br J Rheumatolinstruments did show some responsiveness but 1997;36:878 –83.

10. Wells G, Boers M, Shea B, Tugwell P, Westhovens R, Saurez-RAQoL was not more sensitive than NHP. This isAlmazor M, et al. Sensitivity to change of generic quality ofin accord with � ndings of one previous study of alife instruments in patients with rheumatoid arthritis: prelimin-small number of patients receiving Methotrexate . Asary � ndings in the generic health OMERACT study.

could be expected the eVect sizes both for the clinical J Rheumatol 1999;26:217 –21.variables and HCOL instruments were larger in their 11. Ropes MW, Bennet GA, Cobb S, Jacox R, Jessar RA.

Diagnostic criteria for rheumatoid arthritis. Ann Rheum Disstudy, but no diVerences in the psychometric proper-1959;18:49–53.ties between RAQol and NHP could be demonstrated

12. Eberhardt KB, Rydgren LC, Pettersson H, Wollheim FA.(10). Other investigators comparing responsivenessEarly rheumatoid arthritis – onset, course, and outcome over

between disease speci� c and generic instruments in 2 years. Rheumatol Int 1990;10:135 –42.patients with RA have reported similar � ndings 13. Ritchie DM, Boyle JA, McInnes JM, Jasani MK, Dalakos

TG, Grieveson P, et al. Clinical studies with an articular index(19,20 ).for the assessment of joint tenderness in patients with rheumat-Thus there seems to be no solid proof so far thatoid arthritis. Q J Med 1968;37:393 –406.disease-speci� c instruments have better psychometric

14. Ekdahl C, Eberhardt K, Andersson SI, Svensson B. Assessingproperties assessing HQOL in RA. Generic instru- disability in patients with rheumatoid arthritis. Use of aments also assess other important aspects of quality Swedish version of the Stanford Health Assessment

Questionnaire. Scand J Rheumatol 1988;17:263 –71.of life and allow comparison with other diseases.

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15. Wiklund I, Romansu B, Hunt S. Self-assessed disability in health status instruments for orthopedic evaluation. Med Care1990;28:632 –42.patients with arthrosis of the hip joint. Reliability of the

Swedish version of the Nottingham Health Pro� le. Int Disabil 19. Fitzpatrick R, Ziebland S, Jenkinson C, Mowat A, Mowat A.A comparison of the sensitivity to change of several healthStud 1988;10:159 –63.

16. Hunt S, Wiklund I. Cross-cultural variation in the weighting status instruments in rheumatoid arthritis. J Rheumatol1993;20:429 –35.of health statements: a comparison of English and Swedish

valuations. Health Policy 1987;8:227–35. 20. Hagen K, Smedstad LM, Uhlig T, Kvien TK. The respons-iveness of health status measures in patients with rheumatoid17. Liang MH. Evaluating Measurement Responsiveness.

J Rheumatol 1995;22:1191 –2. arthritis: Comparison of disease-speci� c and generic instru-ments. J Rheumatol 1999;26:1474 –80.18. Liang MH, Fossel AH, Larson MG. Comparisons of � ve

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Appendix 1

Nedanfinner duenupprakningav endel problemmankanha i vardagslivetMarkera nedanompaî staî endet stammer paî digeller inte just nu

Stammer Stammer inte

1 Jagmaî ste gaî och lagga migtidigare anjagskulle vilja(Ihave to gotobedearlier thanIwould like to)

2 Jagar raddatt folkskall rora vid mig(I’mafraidofpeople touchingme)

3 Det ar svaî rt att hitta bekvama skor somjagtycker om(It’sdifficult tofindcomfortable shoesthat Ilike)

4 Jagundviker trangsel paî grundav mitt halsotillstaî nd(Iavoidcrowdsbecause ofmy condition)

5 Jaghar svaî rt att kla paî mig(Ihave difficulty dressing)

6 Jaghar svaî rt att gaî till fotstill affarerna(Ifind it difficult to walktothe shops)

7 Hushaî llsarbete tar laî ngtidfor mig(Jobsabout the house take me a longtime)

8 Iblandhar jagproblematt klara toalettbesok(Isometimeshave problemsusingthe toilet)

9 Jagkanner migofta frustrerad(argochledsen)(Ioftenget frustrated)

10 Jagmaî ste avbryta vadjaghaî ller paî med for att vila(Ihave to keepstoppingwhat Iamdoingtorest)

11 Jaghar svaî rt att anvanda kniv ochgaffel(Ihave difficulty usinga knife andfork)

12 Jaghar svaî rt att koncentrera mig(Ifind it hardtoconcentrate)

13 Iblandvill jagbara vara ifred(SometimesIjust want tobe left alone)

14 Jaghar svaî rt att gaî laî nga strackor(Ifind it difficult to walkvery far)

15 Jagforsoker undvika att ta folki hand(Itry toavoidshakinghandswithpeople)

16 Jagblir ofta nedstamd(Ioftenget depressed)

17 Jagklarar inte av att delta i aktiviteter medminfamilj eller mina vanner(I’munable to join inactivitieswithmy family or friends)

18 Jaghar problemmedatt duscha(Ihave problemstakinga bath/shower)

19 Iblandsatter jagmigner ochgraî ter over mitt halsotillstaî nd(Isometimeshave a good cry because ofmy condition)

20 Mitt halsotillstaî ndgor att jag inte kangaî vart somhelst(My condition limitsthe placesIcango)

21 Jagkanner migtrott vad jagangor(Ifeel tiredwhatever Ido)

22 Jagkanner migberoende av andra(Ifeel dependent onothers)

23 Jagtanker alltidpaî mitt halsotillstaî nd(My condition isalwaysonmy mind)

24 Jagblir ofta argpaî migsjalv(Ioftenget angry withmyself)

25 Det ar alldelesfor anstrangande att gaî ut ochtraffa folk(It’stoomucheffort togoout andsee people)

26 Jagsover daî ligt paî natterna(Isleepbadly at night)

27 Jagtycker att det ar svaî rt att ta handomde manniskor somstaî r mignara(Ifind it difficult to take care ofthe people Iamclose to)

28 Jagkanner att jag inte har kontroll over mitt halsotillstaî nd(Ifeel that I’munable tocontrol my condition)

29 Jagundviker fysiskkontakt(Iavoidphysical contact)

30 Jagkaninte anvanda vilka klader somhelst(I’mlimited inthe clothesIcanwear)

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