Second Department of Medicine, Humanis Klinikum, Lower Austrian Centre for Rheumatology, Stockerau, Austria
Correspondence to: J. Sautner, Second Department of Medicine, Landstrasse 18, Humanis Klinikum, Stockerau, Lower Austrian Centre for Rheumatology, Stockerau, Austria A-2000. E-mail: leeb.khstockerau{at}aon.at
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Abstract |
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Methods. Following an arbitrary procedure employing high intervariable correlations, redundant questions were eventually eliminated. To validate the shortened version, 60 patients with HOA, recruited at four rheumatological centres in Austria, completed the original SACRAH as well as the shortened version. Fifty-five patients suffering from RA of the hands treated at the Second Department of Medicine, Humanis Klinikum Stockerau, also completed both questionnaires.
Results. A total of 11 questions (nine from the function domain and two from the pain domain) were eliminated, leading to the modified score consisting of 12 questions. Comparing the results of SACRAH and M-SACRAH, as well as the domain scores in individual patients, correlation coefficients were r = 0.978 for HOA patients (P<0.0001) and r = 0.986 for RA patients (P<0.0001).
Conclusion. M-SACRAH, the shortened and simplified version of the original SACRAH questionnaire, proved to be as reliable and as representative as SACRAH for hand status in individual HOA and RA patients.
KEY WORDS: Hand function, Osteoarthritis, Rheumatoid arthritis, Simplified scoring questionnaire
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Introduction |
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The SACRAH has been validated and confirmed in 69 HOA and 103 RA patients [6].
The original questionnaire has been used in daily clinical practice for the assessment of HOA as well as RA patients since its development. Patients have been requested to complete the questionnaires while waiting in the out-patient clinic. This was generally considered easy [6] and the completion time was approximately 35 min.
Nevertheless, we decided to modify the SACRAH and to create a shortened and simplified version in order to make the questionnaire easier to use for the patient and to save staff time when evaluating the data.
Another reason for modifying the original scoring system was triggered by the very high Cronbach's alpha value [7], which suggested that the chosen questions measured the tested latent construct very well but also implied the redundancy of some of the questions. This was consistent with expert opinion on the text of the SACRAH, which suggested that some of the questions could be omitted without losing validity.
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Patients and methods |
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To address this, we calculated correlations between all questions within the function domain as well as within the pain domain, using the originally obtained data set [6]. All question results with a correlation coefficient of 0.7 or above with at least two other questions were arbitrarily considered redundant.
The stiffness domain was left unaltered because there was unanimous agreement among the authors that a single domain should consist of at least two questions.
Similarly to the original questionnaire, the average score of each domain was calculated, and the overall average for the three domain scores was then obtained. The overall M-SACRAH therefore ranges between 0 and 100, 0 representing the best and 100 the worst possible status.
The modified questionnaire was established in German and was used only by German-speaking patients and personnel.
Both questionnaires have been translated into English and have been validated by a native speaker, so that it can now be applied in the English-speaking environment.
Patient cohort to evaluate the modified score
Sixty patients diagnosed with HOA, according to the ACR criteria [8], attending one of the out-patients departments of four Austrian centres for rheumatology (Department for Rheumatology, University of Innsbruck, Rheuma-Sonderkrankenanstalt Bad Schallerbach, Rehabilitationszentrum Laab im Walde, and Second Department of Medicine, Humanis Klinikum, Stockerau) between March and May 2003 completed both questionnaires (Table 1).
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Fifty-five patients with RA, according to the ARA criteria [9], treated at the Second Department of Medicine, Humanis Klinikum, Stockerau, also agreed to fill in both questionnaires (Table 1).
All patients were on NSAIDS, either continuously or on demand.
All RA patients were receiving continuous, long-acting DMARD therapy at a stable and efficient dose. Low-dose corticosteroids were also used, up to a maximum dose of 10 mg daily.
Patients with Steinbrocker functional classes III or IV (defined as dependent on external assistance for most of the activities questioned in the function domain of the score) were deliberately excluded from the study. Although we expected very high M-SACRAH values, we decided not to include this patient group in the study. Following the same principle, we also excluded the early arthritis patients in order to achieve a homogeneous patient group.
All patients gave their written informed consent to participation in the study, according to the Declaration of Helsinki. The design of the study was approved by the local ethics committees of all participating centres.
Completion of the questionnaire and further assessments
After initial instruction by a nurse or a resident, the participants completed both forms without further assistance. The order in which the forms were completed was left to the patients discretion. Completed questionnaires were collected immediately to avoid copying of results.
Additionally, the patients and physicians global assessments (PGA, PhGA) were determined, also using a 100 mm VAS. In some of the HOA patients and in all RA patients ESR (first hour) and CRP values (mg/dl) were determined. For the RA group, the disease activity score 28 (DAS28) was also calculated [10]. The necessary components (tender joint count, swollen joint count, ESR in first hour and PGA) were obtained by one of the authors.
Patients with recent hand radiographs (less than 3 months before inclusion in the study) did not undergo additional radiological investigation. Patients without recent radiographs obtained these on inclusion in the study. Apart from the assessment of erosions, no further radiological scores were employed.
Statistics
Correlations of continuous variables were calculated using the Spearman rank correlation. Continuous variables were compared using the Wilcoxon signed rank test. To test the internal consistency of the modified score, Cronbach's alpha was calculated. Results are presented as median (range) for continuous variables. P values <0.05 were considered statistically significant.
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Results |
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The total SACRAH and M-SACRAH values were 22.2 (085.4) and 24.6 (083) (not significant), respectively, for the HOA patients, and 24.7 (084.3) and 27.0 (086.7) (P<0.05) for the RA patients. Detailed results of both questionnaires are presented in Table 3.
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HOA patients reached a PhGA of 20 (080) and RA patients 25 (075). Correlation coefficients with the M-SACRAH were r = 0.51 (HOA) and r = 0.56 (RA).
Correlation coefficients between SACRAH and M-SACRAH in HOA patients were r = 0.978 for the total score (P<0.0001), r = 0.945 for the function domain (P<0.0001), r = 0.958 for the stiffness domain (P<0.0001) and r = 0.912 for the pain domain (P<0.0001) (Fig. 1).
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Cronbach's alpha for the M-SACRAH was 0.949.
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Discussion |
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For the clinical assessment of patients with hand osteoarthritis, the Osteoarthritis Research Society International (OARSI) Consensus meeting of Boston agreed upon a number of desirable measures [11].
The principal outcomes for clinical trials in HOA, as proposed by Bellamy, include pain measurement by VAS, the use of a functional index, patient's global assessment and morphological diagnostics as radiological imaging [11].
These suggestions in general may be extended to patients with other rheumatoid affections of the hand as the categories of impairment seem to be very similar.
Radiological assessment of hand osteoarthritis is able to describe distinct morphological changes of the joints, but has been considered to be inferior to clinical assessment when aiming at a global description of the patient's status [8].
To meet these needs in patients with different rheumatoid affections of the hand, we have introduced the SACRAH [3]. The score has been validated in HOA and RA patients [6], and has been introduced in the routine assessment of patients with respective diseases in our department.
Focusing on HOA patients, Bellamy et al. developed a similar scoring system, using a VAS as well as a Likert scale [12]. Comparing the single items of SACRAH and Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the latter lays similar stress on the function domain. Stiffness is represented by one item and pain by five items. Forty per cent of the function items are clearly confined to housework. Considering the relation of women and men doing housework in central European countries, this is justifiable regarding the higher prevalence of HOA in females.
In contrast, the SACRAH was designed to be applicable regardless of gender and occupation, addressing all patients with rheumatic hand affections. Thus, items which might not be relevant to a patient's daily life should be avoided.
Concerning the stiffness domain, the item starting stiffness after a time of rest remained in the M-SACRAH to address a problem especially mentioned by HOA patients, whereas this item did not reach the final AUSCAN version.
The pain domain of the AUSCAN includes five detailed questions of pain during certain activities. The SACRAH approach is a more general one, addressing pain at times of rest and during activity.
Concerning the amount of time necessary to answer AUSCAN or M-SACRAH questionnaires, despite a similar number of questions, completion time is supposed to be longer for the AUSCAN, because both VAS and Likert scales have to be filled in. The development of both scores is different; the original SACRAH was evolved using a Delphi approach, employing the suggestions of experienced physicians, patients and occupational therapists. In contrast, for the AUSCAN, eight existing questionnaires were screened for predefined areas of disability [12]. Out of a large item pool, using a complex procedure, finally 15 questions (five pain, one stiffness and nine physical function) were selected. The authors mentioned a second group of five pain, one stiffness and 18 physical function reserve items, to be reported separately at a later date, to address a methodological issue relating to early vs late item reduction in index construction.
The standard application of the SACRAH proved to be easy for the patient [6]. Nevertheless, answering 23 questions requires approximately 35 min for the patient and another 3 min for the evaluation of the questionnaire. We therefore aimed to modify the original score by removing redundant questions. The chosen procedure was based on the high Cronbach's alpha of the original score. Multiple and high inter-item correlations identified the questions which were regarded as equally represented by at least one other question of the same domain.
Within the function category, redundant questions encompassed a number of activities, as depicted in Table 2.
Although all items of the original SACRAH were established by a Delphi approach employing the suggestions of patients, occupational therapists and physicians, the impact of the questioned activities on the patients global impairment is obviously well represented by the questions that remained in the modified score. The results of the function category of the modified score indeed still mirrored the respective results of the SACRAH very well. Obviously, the remaining items concerning daily life represent a thorough reflection of the patient's individual functional impairment without encompassing manual activities of all areas of daily life.
The domain score of the stiffness category that was left unaltered correlated very well between SACRAH and M-SACRAH. Comparing Cronbach's alpha for this question category with the original patient cohort [6], it turned out to be very similar (0.79 vs 0.8), showing very consistent results in two distinct consecutive patient cohorts. This may be interpreted as an indicator of a valid score.
The results of the pain domain tend to be higher in RA patients employing the M-SACRAH as opposed to the SACRAH. This is due to the removal of the items pain during the night and pain during regular daily work. These items produced lower VAS results than the question pain during intensive work, which obviously led to a lower average score of the pain category of the SACRAH. Nevertheless this higher pain category score correlated very well with the respective domain score of the SACRAH.
Self-administered questionnaires generally profit from the exclusion of investigator-dependent variation [13].
Addressing the general situation of RA patients, the Arthritis Impact Measurement Scales (AIMS) [14] and subsequently the Arthritis Impact Measurement Scales 2 (AIMS2) [15] have been developed. In contrast to the SACRAH and M-SACRAH, these questionnaires have different aims. They are designed to draw a multidimensional image of the patient's status, assessing not only physical, but also emotional and social wellbeing.
Methodologically closer to our work are the studies of Hudak et al. on an upper extremity outcome measure, the Disabilities of the Arm, Shoulder and Hand (DASH) [16], dealing with disabilities of the arm, shoulder and hand. Again the difference is marked by the larger variety of components, also including questions concerning present psychological and social status. This outcome measure was designed to describe a variety of musculoskeletal diseases and injuries of the upper extremity and as such has a broader scope than the M-SACRAH.
The definition of RA emphasizes the involvement of hand joints [8]. The same patients, suffering from HOA, only rarely complain about concomitant subjective impairment of elbows or shoulders, although these joints occasionally may show signs of OA. Our goal was the development of a tool to assess only hand involvement in RA and HOA patients. Although some of the function items of the DASH overlap with the M-SACRAH, the more general questions regarding pain and stiffness do not, in our opinion, describe the specific problems of RA and HOA patients, as do the respective questions of the SACRAH and M-SACRAH, which are restricted to the hand. The DASH has been applied predominantly in trauma patients and patients undergoing orthopaedic surgery, a cohort of patients for which the SACRAH was not designed.
Both scores meet their goals to measure disabilities or impairment, as perceived by the individual, in different groups of patients.
As mentioned above we excluded patients with Steinbrocker classes III and IV from the study, expecting a function domain score of approximately 100. Whether these patients would also achieve similar high scores in the stiffness and pain domains cannot be answered yet but constitutes an interesting topic to investigate in future. This would clarify the possible use of M-SACRAH in highly and even completely disabled patients.
How reliable the patients subjective assessment of their clinical status is has recently been shown elegantly by Teleman et al. [17]. DAS28 scores, traditionally obtained by the physician (DDAS28), were compared with DAS28 scores assessed by the patients themselves (PDAS28). The high correlation observed indicates the ability of patients to judge their own disease activity well.
The same patient self-reported outcome indices used to distinguish between active treatment and placebo treatment in RA patients appeared to be as informative as assessor-derived indices [18].
When correlating PhGA and PGA with the M-SACRAH, the moderate correlations of the PhGA and the M-SACRAH, as opposed to the better correlations of PGA and the modified score, indicate that the physician's judgement of the patient's disease activity was generally worse than the patient's own assessment.
For the cohort of RA patients, correlations of the modified score with the DAS28 proved the ability of the M-SACRAH to measure disease activity as well.
Recently, efforts to shorten the well-established and broadly used WOMAC [4] were reported [19]. In contrast to our findings concerning the M-SACRAH, the short form of WOMAC (SF-WOMAC) does not seem to equal the original version. In the opinion of the authors, removal of questions may lead to a decline in content validity and may have a negative impact on index performance in other research and clinical environments.
Whether the modification of the SACRAH bears similar risks in its application in different clinical environments may not be answered currently.
Patient-centred and self-administered outcome measures represent a central focus in contemporary rheumatology, the importance of which is considered unassailable [20].
Apart from clinical and laboratory data, these methods may offer insight into the patient's perceived health status.
Meeting these demands, the M-SACRAH is an easily and quickly applicable and reproducible means to assess the individual patient's actual situation.
Future possibilities are its application in other distinct rheumatoid affections of the hands, trials to assess the efficacy of specific drugs and possibly its use in an English-speaking environment. To prove its sensitivity to change, as with the original questionnaire, longitudinal studies are required.
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Acknowledgments |
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The authors have declared no conflicts of interest.
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References |
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