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A tool for the assessment of hand involvement in rheumatic disorders in daily routine – the SF-SACRAH (short form score for the assessment and quantification of chronic rheumatic affections of the hands)
1st and 2nd Department of Medicine, Center for Rheumatology, Lower Austria, State Hospital Korneuburg-Stockerau, Karl Landsteiner Institute for Clinical Rheumatology, A-2000 Stockerau, Landstrasse 18, Austria
1st and 2nd Department of Medicine, Center for Rheumatology, Lower Austria, State Hospital Korneuburg-Stockerau, Karl Landsteiner Institute for Clinical Rheumatology, A-2000 Stockerau, Landstrasse 18, Austria
1st and 2nd Department of Medicine, Center for Rheumatology, Lower Austria, State Hospital Korneuburg-Stockerau, Karl Landsteiner Institute for Clinical Rheumatology, A-2000 Stockerau, Landstrasse 18, Austria
1st and 2nd Department of Medicine, Center for Rheumatology, Lower Austria, State Hospital Korneuburg-Stockerau, Karl Landsteiner Institute for Clinical Rheumatology, A-2000 Stockerau, Landstrasse 18, Austria
1st and 2nd Department of Medicine, Center for Rheumatology, Lower Austria, State Hospital Korneuburg-Stockerau, Karl Landsteiner Institute for Clinical Rheumatology, A-2000 Stockerau, Landstrasse 18, Austria
Address correspondence and reprint requests to: Prim. Dr Burkhard F. Leeb, M.D., Director, 1st and 2nd Department of Medicine, Center for Rheumatology, Lower Austria, State Hospital Korneuburg-Stockerau, Karl Landsteiner Institute for Clinical Rheumatology, A-2000 Stockerau, Landstrasse 18, Austria. Tel: 43-2266-609-701; Fax: 43-2266-609-707.
1st and 2nd Department of Medicine, Center for Rheumatology, Lower Austria, State Hospital Korneuburg-Stockerau, Karl Landsteiner Institute for Clinical Rheumatology, A-2000 Stockerau, Landstrasse 18, Austria
To establish a questionnaire for quantification of hand involvement in osteoarthritis (OA) of the hands and rheumatoid arthritis (RA) meeting daily routine requirements.
Patients and methods
The smallest number of questions of the modified score for the assessment and quantification of chronic rheumatic affections of the hands (M-SACRAH) providing reasonable reliability was identified by factor analysis and calculating Cronbach's alpha, subsequently resulting in a five-item scale, the short form-SACRAH (SF-SACRAH), which was then administered to 176 RA and 71 hand-OA (HOA) patients simultaneously with the M-SACRAH. Additionally, patient's satisfaction (PatSAT) with disease status was assessed (according to the Austrian school marking system from 1 to 5). Gamma was calculated to assess the agreement of the SF-SACRAH with the M-SACRAH and between the single corresponding questions of different formats. The Wilcoxon rank test was applied to estimate the relationship between PatSAT and the SF-SACRAH.
Results
Alpha for the SF-SACRAH in 176 RA and 71 HOA patients amounted to 0.869 and to 0.897, respectively, indicating high internal consistency. In both patient groups the SF-SACRAH was found to be significantly correlated to the M-SACRAH (both Ps<0.01). Agreement between the corresponding questions of both scales was significant in both patient groups by calculating gamma (average gamma 0.683 in HOA and 0.847 in RA). PatSAT and SF-SACRAH values were highly significantly correlated (P<0.001) proving the score's external validity.
Conclusion
The SF-SACRAH proved to be a brief and practicable tool to assess hand involvement in OA and RA meeting the requirements of daily routine.
. Tender and swollen joint-counts, patient's global assessment (PatGA) or physician's global assessment (PhGA), and determination of laboratory parameters as erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) are mirroring disease activity, but do not reflect, if only in part, the extent of functional hand impairment, a decisive parameter for the patient's well being as well as for work disability
. Several questionnaires to quantify the hand involvement in rheumatic diseases have been elaborated (superior limb section of arthritis impact measurement scales (AIMS2), functional index for hand arthropathies (FIHOA), Duruoz hand index; disability of the arm, shoulder and hand questionnaire (DASH), Michigan hand outcomes questionnaire (MHOQ), Cochin index and the Australian/Canadian osteoarthritis hand index (AUSCAN)
Dimensionality and clinical importance of pain and disability in hand osteoarthritis: development of the Australian/Canadian (AUSCAN) osteoarthritis hand index.
, a questionnaire comprising 23 questions to be answered by visual analogue scales (VASs: 0–100 mm) covering the following three domains: function, joint stiffness and pain. This questionnaire was modified (M-SACRAH) by reducing the number of questions resulting in 12 questions with a minimum of at least two questions covering each domain
Development of the M-SACRAH, a modified, shortened version of SACRAH (score for the assessment and quantification of chronic rheumatoid affections of the hand).
. However, all these questionnaires, including the two SACRAHs, do not meet the requirements to be applied in daily routine, as they either comprise too many questions or are too difficult and time consuming to be calculated or both.
Therefore, we tried to develop a tool for the assessment of hand involvement in rheumatic disorders which is easily applicable in daily clinical practice. The new tool should be easy to calculate and time sparing to complete while still providing the most accurate data possible. Providing the physician with sufficient information about the disease course and red flags in case of deterioration can be regarded the most important requirement for any routine disease activity monitoring tool.
Patients and methods
Questionnaire
A comparative analysis of the M-SACRAH and the AUSCAN in 61 patients with HOA using factor analysis revealed a high degree of redundancy of both questionnaires
A comparison of the M-SACRAH (modifided score for the assessment of chronic rheumatoid affections of the hands) and the AUSCAN (Australian/Canadian osteoarthritis hand index) in hand osteoarthritis patients.
. Therefore, we attempted to identify the smallest number of questions of the M-SACRAH providing reasonable reliability, indicated by a standardized item alpha >0.7 by combining the questions showing the highest item loadings. At the end of the process the combination of five questions, three out of the function domain, and one out of the pain and stiffness domain, respectively, namely question numbers 1, 4, 7, 9 and 12 of the M-SACRAH, were found to meet these criteria (Table II). This newly established scale, the SF-SACRAH, was then investigated for its psychometric properties. We compared it with the original SACRAH in those 172 patients (69 with HOA, 103 with RA) who were assessed to create the respective scale
Development of the M-SACRAH, a modified, shortened version of SACRAH (score for the assessment and quantification of chronic rheumatoid affections of the hand).
A tool for the assessment of hand involvement in rheumatic disorders in daily routine – the SF-SACRAH (short form score for assessment and quantification of chronic rheumatic affections of the hands).
, the format of the questionnaire was changed from VASs to Likert-scales (LSs) from 0 to 10 in order to enhance the applicability of the SF-SACRAH. Zero as an answer to the three questions concerning function means “possible without any difficulty”, 10 means “impossible”; concerning stiffness a value of 0 indicates “no stiffness”, and 10 “unbearable stiffness” and very similar, in the last question concerning pain 0 indicates “no pain” and 10 “unbearable pain”.
While the M-SACRAH needs measuring of 12 VAS from 0 to 100 mm followed by adding and dividing the sum by 12 (resulting in a range from 0.0 to 100.0), the SF-SACRAH is a sum up of the answers given to each question with a subsequent division by five (the number of questions). Thus the SF-SACRAH is easily calculated and ranges from 0 to 10. The questionnaire was developed and applied in German language. The translated English version in Table II is coined by the translation of the original SACRAH
To prove internal consistency and validity of the new instrument 179 RA patients and 71 HOA patients were included into this validation study. RA patients were diagnosed according to the American Rheumatism Association criteria
(median age 60 years, range 41–74 years, 91% female). All of the patients presented at the outpatient department between May and September 2006 and gave their informed consent to be enrolled. All RA patients were on therapy with non-steroidal anti-inflammatory drugs (NSAIDs) either continuously or on demand, 169 patients (96.3%) were on different disease modifying antirheumatic drugs (DMARDs). One hundred and eighteen patients (67.2%) received additional low dose corticosteroids. Patients with Steinbrocker functional stage III or IV were deliberately excluded from the study since they are dependent on external assistance for most of the activities asked for in the functional questions of the M-SACRAH. 71.8% (51) of the HOA patients were on three monthly therapy with symptomatic slow acting drugs in osteoarthritis (SYSADOA; condroitinsulphate or diacerein), all of them on NSAIDs or analgesics on demand (for demographic data see Table I). Patients were asked to complete the new SF-SACRAH and the M-SACRAH.
Table IDemographic data
Disease
RA (*median, range)
HOA (*median, range)
No. of patients
179
71
Correctly completed
176
71
Age in Years
*61 (32–80)
*60 (41–74)
Gender (% female)
84
91
Disease duration in months
*65 (5–600)
*45 (4–480)
Rheumafactor positive %
54.9
–
M-SACRAH
*15.75 (0.0–88.0)
*17.42 (1.2–88.1)
SF-SACRAH DAS28
*1.6 (0.0–8.0)
*1.6 (0.0–8.2)
3.84 (1.25–6.16)
–
Time to complete and evaluate SF-SACRAH in seconds
Patients were randomly assigned to complete one of the questionnaires after initial instruction by a nurse or resident without further assistance during the waiting period and the other one at the physician's desk, which resulted in an average time lag of 30 min upon completion of both questionnaires.
with the disease status was assessed according to the Austrian school marking system (1=excellent to 5=unsatisfactory). PatGA and PhGA (both 0–100 mm VAS) were recorded as well.
Statistics
Internal consistency testing was performed by calculating standardized item alpha
. A value greater than 0.7 is commonly regarded a marker of substantial reliability on a group level, for the individual application even higher values were required
. The Spearman rank correlation was applied to examine the relationship between SF-SACRAH and M-SACRAH levels. Gamma as an ordinal symmetric measure was calculated to prove agreement between the questions of the SF-SACRAH and the M-SACRAH, respectively, as they have a different format. To reveal the relationship between PatSAT and the SF-SACRAH and M-SACRAH levels the Wilcoxon rank test was applied as PatSAT was shown to be not normally distributed according to the Kolmogorov–Smirnov accommodation.
Results
In the first step of its development, the SF-SACRAH appeared to provide high internal consistency (standardized item alpha 0.731 and 0.837, respectively) and was highly significantly correlated to the M-SACRAH (r=0.639, P<0.001) and significantly to the original SACRAH (r=0.492, P<0.001) in the respective patients cohorts
Development of the M-SACRAH, a modified, shortened version of SACRAH (score for the assessment and quantification of chronic rheumatoid affections of the hand).
[Fig. 1(a and b)]. Moreover, a highly significant correlation of the SF-SACRAH to PatGA (r=0.784, P<0.0001) and PhGA (r=0.646, P<0.001) could be found.
Fig. 1(a) Correlation of the SF-SACRAH to the original SACRAH and (b) of the SF-SACRAH to the M-SACRAH in the respective (original) cohorts (Spearmen rank correlation).
In the second step all but three patients (179 with RA and 71 with HOA) completed the SF-SACRAH correctly. Three out of the 179 RA patients, did not complete the M-SACRAH correctly, writing comments instead of marking the VAS or did not mark the VAS accurately. All others reported no difficulties with filling in the forms. In 27 RA and 11 HOA patients the time to complete the SF-SACRAH questionnaire and the time to calculate were measured. As in RA patients as well in HOA patients this procedure was finalized in less than 1 min (see Table I).
The median SF-SACRAH amounted to 1.6 (0.0–8.0) in the 179 RA and to 1.6 (0.0–8.2) in the 71 HOA patients. The respective M-SACRAH values were 15.75 (0.0–88.0) in RA and 17.42 (1.2–86.1) in the patients with HOA.
The mean disease activity score (DAS28) in the RA patients was 3.84 (1.25–6.16), indicating overall moderate disease activity. Mean satisfaction with disease status was 3 in the RA-patient group and 2 in the HOA patient group (range 1–5 in both groups).
The SF-SACRAH was found to be highly correlated to the M-SACRAH in the RA (n=179) as well as in the HOA (n=71) patient group (r=0.846 for RA and 0.699 for HOA; both Ps<0.001) according to the Spearman rank correlation [Fig. 2(a and b)].
Fig. 2(a) Correlation of the SF-SACRAH to the M-SACRAH in (a) 176 RA and (b) 71 HOA patients (Spearmen rank correlation).
As the questions' format was changed with the invention of the SF-SACRAH, not only the agreement between the final scores, but also between the single questions of the SF-SACRAH and the corresponding ones of the M-SACRAH was of interest. For this reason gamma as a symmetrical ordinal measure was calculated. In the HOA group all five questions of the SF-SACRAH were in highly significant agreement with the respective ones of the M-SACRAH (average gamma 0.683, all Ps<0.001). The average gamma for the RA group amounted to 0.847 (P for all questions <0.001).
Alpha as a measure for internal consistency was 0.869 for SF-SACRAH in RA patients and 0.897 for HOA patients, respectively. Both values reasonably surpass the lower limit of 0.7.
The M-SACRAH proved to be a three-component score. Question 1 of the M-SACRAH loaded on component 3 exclusively and was, therefore, included into the SF-SACRAH (loading 0.949). Component 1 comprised question 2 to question 8 (loading range 0.602–0.845) with questions 4 and 7 loading strongest (0.785 and 0.845, respectively). Questions 9–12 loaded on component 2 (0.587–0.888), the questions of the M-SACRAH with the highest loadings, namely 9 and 12 were included into the SF-SACRAH questionnaire (loading 0.808 and 0.888, respectively). Additionally all questions chosen for the SF-SACRAH showed the lowest loadings on the other components (0.002–0.246). Due to the small differences in loading on the components 1 and 2, respectively, those questions can be regarded redundant in this respect.
Factorial analysis of the SF-SACRAH by principal component analysis revealed, that each single question contributes significantly (factor loading 0.682–0.931) to the aggregate result with some minor differences in the hierarchy of questions between RA and HOA.
To test for external validity the Wilcoxon rank test was applied to analyze the relationship between PatSAT with disease status and the SF-SACRAH. For both patient groups a highly statistically significant relationship between the SF-SACRAH and PatSAT could be found (P<0.001).
Discussion
The main objective of this study was to assess whether a shortened version of the SACRAH, the SF-SACRAH, could be used as a completely patient administered tool for daily monitoring. The SF-SACRAH should enable physicians to get reliable information about the disease course based on patients' self report and it should be sensitive enough to sound the alarm if deteriorations occur. A practicable and easily calculable tool for assessment of hand impairment can be regarded a prerequisite for effective and successful patient monitoring in clinical routine. It has been shown that close monitoring with validated tools improves the outcome of RA patients
Dimensionality and clinical importance of pain and disability in hand osteoarthritis: development of the Australian/Canadian (AUSCAN) osteoarthritis hand index.
. Nevertheless, all of them do not meet the requirements for daily practice as they miss crucial attributes: they are either too long or need complicated calculation, or both. Completing and calculating the SF-SACRAH is done in less than 1 min. In contrast, the median completion time for the M-SACRAH appeared to be 1 min 35 s (range 1 min 20 s to 2 min 55 s),
and evaluation is also complicated and time consuming because of the VASs. Other scores are more time consuming as for example the mean time to perform the FIHOA takes 2.5 min
The SF-SACRAH's predecessors, the SACRAH and the M-SACRAH, have been shown to be valid in expressing hand involvement in RA and HOA patients and they showed to be sensitive to change in RA patients. The relations of these two instruments to the other available questionnaires are discussed in the original papers
Development of the M-SACRAH, a modified, shortened version of SACRAH (score for the assessment and quantification of chronic rheumatoid affections of the hand).
. One fact should be emphasized: the AUSCAN was also validated for HOA in a Likert scaled format (AUSCAN LK 3.0), but it comprises more than five questions
. Therefore, we felt justified to presume that the application of statistical procedures such as factorial analysis and reliability analysis of the M-SACRAH could ultimately result in a short and reliable, patient orientated tool, which can be used in daily routine.
However, would this success hold true, when the new instrument was applied in daily routine and compared with the M-SACRAH? Alpha as a measure of the SF-SACRAH's reliability in the RA and HOA patients investigated was above 0.8, which can be regarded the threshold of internal consistency on an individual basis. Moreover, alpha usually increases with the number of items and can be also regarded a measure of redundancy. Though, a tool comprising five items and providing alpha levels >0.8 cannot easily be denominated redundant.
Given the results of the principal component analysis of the SF-SACRAH the choice of the questions turned out to be an appropriate one. All items contribute significantly to the aggregate result without essential differences with respect to their loading.
The change of the questions' format from VAS in the M-SACRAH to an 11-point ordinal scale in the SF-SACRAH constituted another concern. This was done to enhance applicability by avoiding time consuming measurement of VAS in order to facilitate the calculation. By agreement analysis an almost perfect agreement between the VAS of the M-SACRAH and the ordinal scales of the SF-SACRAH could be revealed. It is important to notify that in order to avoid an interaction patients completed both questionnaires after an interval of half an hour on average and in random order.
Moreover, no major differences were seen on applying the SF-SACRAH in HOA or RA patients and it proved to be in accordance with patient's satisfaction of disease status. There is a slightly higher level of correlation between the SF-SACRAH and M-SACRAH in the RA group. An explanation could be due to the different numbers of patients included in the two groups.
Of course there are shortcomings of this study: first, the effect of handedness was not investigated, but all functional questions can be regarded directed primarily to the dominant hand, while the two remaining questions (stiffness and pain) are directed to both hands. Further investigations will be necessary to explore whether there is a decisive influence of dominant hand involvement. If impairment of the dominant hand is apparent, the non-dominant hand is the one to perform daily activities and this fact should per se worsen the score, as difficulties increase. Second, the SF-SACRAH's sensitivity to change has to be proven in a longitudinal study as with the original instruments
. Third, the influence of global pain, assessed on a separate VAS, was not investigated as assessment of pain in the evening is part of the questionnaire (question 5). Further investigations will have to assess whether there is an explicit influence of global pain on the score. However, it may be anticipated that low individual pain thresholds, as known e.g., for patients with fibromyalgia, may increase the SF-SACRAH results
. Forth, although in the meantime a translated English version of the M-SACRAH was used in aromatase inhibitor associated arthralgias in breast cancer survivors
Validation of the modified score for the assessment and quantification of chronic rheumatoid affections of the hands (M-SACRAH) in aromatase inhibitor-associated arthralgias in breast cancer survivors.
, the SF-SACRAH is not yet validated in the English version. Nevertheless, the SF-SACRAH in the German version already proved to be capable of screening a nephrologic patient cohort for hand disorders at a sensitivity and specificity of 80%
In summary the effort to create a short and practicable tool to measure hand impairment in rheumatic diseases, in particular in RA and HOA, could be successfully finalized. The SF-SACRAH is a patient orientated score which provides high internal consistency and proved external validity. The three questions concerning function (locking/unlocking a door, fastening/unfastening a zip and turning the pages of a newspaper) are easy to be answered by everybody since these activities have to be performed everyday by females and males. The time necessary to complete and evaluate the SF-SACRAH was found to be lower than 1 min.
Rheumatology as a discipline has to live with the fact that hard and uninfluenced parameters for disease activity monitoring are not available
. The SF-SACRAH, however, could constitute a possibility for routine monitoring of some rheumatic diseases, in particular HOA, which constitutes a disease, where an improvement of treatment as well as the monitoring strategies deems necessary. And it may be a tool not only for rheumatologists, but also and maybe primarily, for non-rheumatologists.
Conflict of interest
Dr Leeb has received consultancy fees from TRB Chemedica International SA, AESCA (Austria), Wyeth-Lederle (Austria), Abbott Laboratories (Austria), Centocor (Europe), Roche (Austria), Fresenius-Kabi (Austria), CSC-Pharma (Austria), Dr Kolassa Pharma (Austria), and Sanova-Pharma (Austria). He has performed clinical trials for Centocor, Abbott, Amgen, Institut Biochimique SA (IBSA), Altana, Tropon AG, and Helsinn. Dr Rintelen was a coinvestigator in clinical trials for Abbott, Amgen, Tropon AG, IBSA, and Helsinn and has received consultancy fees from Fresenius-Kabi (Austria).
Acknowledgements
We wish to thank DGKS Gerlinde Ramharter, DGKS Elisabeth Hagmann and Mrs Monika Weiskirchner for collaboration distributing the questionnaires to the patients and sometimes instructing the patients how to complete without exerting influence on their answers.
References
Michet C.
Update in the epidemiology of the rheumatic diseases.
Dimensionality and clinical importance of pain and disability in hand osteoarthritis: development of the Australian/Canadian (AUSCAN) osteoarthritis hand index.
Development of the M-SACRAH, a modified, shortened version of SACRAH (score for the assessment and quantification of chronic rheumatoid affections of the hand).
A comparison of the M-SACRAH (modifided score for the assessment of chronic rheumatoid affections of the hands) and the AUSCAN (Australian/Canadian osteoarthritis hand index) in hand osteoarthritis patients.
A tool for the assessment of hand involvement in rheumatic disorders in daily routine – the SF-SACRAH (short form score for assessment and quantification of chronic rheumatic affections of the hands).
Validation of the modified score for the assessment and quantification of chronic rheumatoid affections of the hands (M-SACRAH) in aromatase inhibitor-associated arthralgias in breast cancer survivors.
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