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Hand Surgery, Vol. 20, No. 1 (2015) 33–38 © World Scientific Publishing Company DOI: 10.1142/S0218810415500045
THE GREEK VERSION OF THE HAND20 QUESTIONNAIRE: CROSSCULTURAL TRANSLATION, RELIABILITY AND CONSTRUCT VALIDITY Thomais Goula,‡ Athanasios Ververidis,*,‡ Grigorios Tripsianis,† Konstantinos Tilkeridis*,‡ and Georgios I. Drosos*,‡ Hand Surg. 2015.20:33-38. Downloaded from www.worldscientific.com by FLINDERS UNIVERSITY LIBRARY on 02/07/15. For personal use only.
*Department
of Orthopaedic Surgery of Medical Statistics, Medical School, Democritus University of Thrace 68100 Alexandroupolis, Greece †Department
‡
University General Hospital of Alexandroupolis 68100 Alexandroupolis, Greece
Received 19 June 2014; Revised 1 September 2014; Accepted 2 September 2014; Published 20 January 2015 ABSTRACT The English version of Hand20 questionnaire was translated into Greek and cultural adaptation was performed. The validity was assessed in 134 patients with a variety of upper limb disorders. A comparison of Hand20 and DASH was also performed. All patients completed EQ-5D, Hand20 and DASH questionnaire. Test–retest reliability was assessed in a subgroup of 37 patients. We assessed the convergent validity of Hand20 by correlating its scores to DASH and EQ-5D scores. We also compared the completeness of Hand20 and DASH. We found no statistically significant differences in Hand20 scores between the 1st and 2nd measurements as well as a strong correlation between Hand20 and the other two questionnaires. There were also better rates of response and fewer missing data even in elderly individuals. Keywords: Hand20; DASH; Upper Limb Disorders; Translation.
INTRODUCTION
between countries, given the wide socio-cultural diversity of the populations studied and the difficulties of international standardisation of instruments, all of which can radically affect the results. Several outcome measures for the evaluation of the functional status of the upper extremity have been developed. There are numerous questionnaires and scales that are easy to complete by patients before or after a treatment. Some of them describe the general health of the patient1 while some are jointspecific2,3 or disease-specific.4,5 However, choosing the most
Health status measures or instruments are questionnaires designed to measure specific aspects of health e.g. physical capacity, mental state, cognitive function or pain associated with disease. Appropriately selected health status measures by health personnel can also be used for purposes of policy and planning to evaluate the effects of clinical practice on clinical outcomes. At the European level, the major problem with all of the above health status measures is their comparability within and
Correspondence to: Dr. Thomais Goula, Zallogou 31, PC:67100, Xanthi, Greece. Tel: (þ30) 697-488-9349, (þ30) 254-102-1682, Fax: (þ30) 255-103-0369, E-mail: [email protected] 33
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appropriate tool for assessing every condition of an affected upper limb seems to be a difficult task. A widely accepted and most commonly used questionnaire nowadays is the Disability of the Arm Shoulder and Hand (DASH) Questionnaire6 — developed by the American Academy of Orthopaedic Surgeons (AAOS). It is a self-administered, region-specific instrument for measuring disabilities and symptoms of upper extremity disorders using a five-level Likert scale. Recently, Orthopaedic Surgeons of the Department of Hand Surgery in the Nagoya University, School of Medicine developed a new illustrated questionnaire for disorders of the upper limb composed of 20 short, easy-to-understand questions accompanied by explanatory illustrations (19 of the 20 questions).7 Their study showed that the Hand20 questionnaire provided validation comparable with that of the DASH Japanese version (DASH-JSSH)8 and that most patients even elderly participants with cognitive deterioration had no difficulty in completing the Hand20. The main purpose of our study was the translation and cross-cultural adaptation of the Hand20 for Greek patients with disorders of the upper limb. Secondarily, the Greek version of Hand20 was compared to the DASH version.
Table 1 Diseases and Injuries in Participants in the Study by Number. Diseases and Injuries
Number per Disorder
Entrapment neuropathy
Carpal Tunnel Syndrome 28 Ulnar Neuritis 3 De Quervain Syndrome 11
Stenosing tenosynovitis Osteoarthritis in the hand Extensor tendon injury Flexor tendon injury Shoulder pathology
Ganglion Hand fractures
Elbow fractures Forearm fractures
Humeral shaft fractures Miscellaneous
Rotator cuff pathology 10 Biceps tendonitis 3 Frozen shoulder 2 Other 16 Carpal bone fractures 4 Metacarpal fractures 2 Phalangeal fractures 1 Radial head fractures Distal radial fractures 9 distal ulnar fractures 2 Ulnar & radial fractures 1 Elbow bursitis 2 Hand tendonitis 2 Shoulder dislocation 3 Other 5
Total
Total 31 11 5 10 2 31
4 7
3 12
6 12
134
MATERIAL AND METHODS Patients The study was conducted on a total of 134 patients (92 (68.7%) females, 42 (31.3%) males; mean age: 51:72 14:78 years, range, 18–77 years) with a variety of upper limb disorders and with their symptoms being stable during the previous four weeks. They attended the outpatient’s department of the Orthopedic Surgery Department of our hospital, enrolled in a consecutive manner from February to September 2013. The inclusion criteria were (a) Greek native language, (b) unilateral disorder of the upper limb, (c) age above 18 years, (d) ability to complete questionnaires independently, (e) moderate to excellent general health condition (patients with chronic fatal diseases were excluded). The study protocols were reviewed and approved by the Ethics Committee of our hospital. Selected patients were given a description of the study as well as additional information about the completion of the
questionnaires. In Table 1, the diseases and injuries included in our study and their frequency, are presented.
Translation Procedure A Greek translation was made using a forward–backward translation protocol according to the guidelines of Guillemin et al.9,10 Two translations were made independently and translated backwards by two independent individuals whose native language was Greek but who were also proficient in English. These versions were compared with the original by a committee, composed of a methodologist, a health professional, a language professional, as well as of all translators (both forward and backward), and the final translation was made. The last step of the translation procedure was the pretesting on several patients (pilot study with 10 patients). No attempt was made to make cultural adaptations to the questionnaire because of the existing illustrations that facilitate the comprehension of
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The Greek Version of the Hand20 Questionnaire
Hand20 by Greek patients (as the pilot study showed), therefore, there is no assessment of concept equivalence and difficulty of the translation as recommended by Rosales et al.11
Hand Surg. 2015.20:33-38. Downloaded from www.worldscientific.com by FLINDERS UNIVERSITY LIBRARY on 02/07/15. For personal use only.
Assessment of Reliability and Validity After signing an informed consent, all patients completed the Greek version of Hand20, DASH and EQ-5D questionnaire during their first visit in the outpatient’s Orthopaedic Department of our hospital. The EQ-5D is a public domain quality of life questionnaire from the Euro-Qol group, which has been validated in a number of countries and cultural settings1 (EuroQol.org). It allows the participants to indicate their health state by indicating the most applicable statement in five parameters, including mobility. The EQ-5D also includes a visual analogue scale (VAS) which is a self-scoring measure of current health status from 0 (worst imaginable health state) to 100 (best imaginable health state). Reliability was investigated by examining the reproducibility and internal consistency based on the test–retest method.12,13 For this purpose, 37 patients scheduled for a surgical intervention of the upper limb, completed both Hand20 and DASH questionnaires twice, with one week interval. We assumed that the clinical status of these patients was unlikely to have a significant change before the presently scheduled surgery.
Statistical Analysis Statistical analysis of the data was performed using the Statistical Package for the Social Sciences (SPSS), version 19.0 (IBM). The scores of all questionnaires were expressed as the mean score standard deviation (SD) and as the median score with the interquartile range (25th to 75th percentile); qualitative variables were expressed as frequencies (and percentages). The normality of quantitative variables was tested with Kolmogorov–Smirnov test. The internal consistency of Hand20 and DASH was assessed using the Cronbach’s a coefficient. The test–retest reliability was analyzed using the intra-class correlation coefficient, Pearson’s r and Spearman’s correlation coefficients, paired samples t test and Wilcoxon signed ranks test in the subgroup of patients, who were re-examined and who had reported no significant change in the functional status of their affected upper limb during the period that had elapsed. The convergent validity of Hand20 was assessed by correlating their scores with
35
other well-established questionnaires (DASH and EQ-5D), using Pearson’s r and Spearman’s correlation coefficients. The association of Hand20 with patients’ age was also examined by employing, Pearson’s r and Spearman’s correlation coefficients. The chi-square test was used to evaluate any potential association between quantitative variables. All tests were two tailed and statistical significance was considered for p values less than 0.05.
RESULTS Reliability and Validity The Cronbach’s alpha coefficient for the 20 items in Hand20 was high (a ¼ 0:956). When the alpha coefficient was calculated for each of the 20 items by eliminating each item one by one, the range was 0.952–0.957, and no item was found to change the internal consistency substantially. The alpha coefficient for the 30 items in DASH was also high (a ¼ 0:962, ranging from 0.959 to 0.962 when the 30 items were deleted one by one). Test–retest reliability of Hand20 was calculated based on the results of 37 patients (10 males; mean age: 51:497 11:64 years; with an interval of 7 days). The difference between the individual scores of the initial assessment and reassessment of the Hand20 ranged from 20.00 to 9.06, with a mean difference of 0:51 5:44. We found no statistically significant differences in Hand20 scores between the 1st and 2nd measurements (mean scores SD: 35:02 22:87 versus 35:53 23:67, p ¼ 0:573, paired samples t test; median scores (interquartile range): 30.77 (15.65–53.25) versus 30.00 (14.74– 56.00), p ¼ 0:884 Wilcoxon signed ranks test) (Table 2). Moreover, correlation analysis revealed an intra-class correlation coefficient of 0.986 (95% CI, 0.973–0.993; p < 0:001), a
Table 2 The Median and Range of Hand20 and DASH Scores*. Instrument Scale Hand20 (1st interview) n ¼ 134 Hand20 (2nd interview) n ¼ 37 DASH (1st interview) n ¼ 134 DASH (2nd interview) n ¼ 37
Median
Range
30.77 30.00 75.00 64.58
15.65–53.25 14.74–56.00 50.52–82.76 45.99–78.33
*Hand20 score, sum of n responses/n 10; DASH score, (sum of n responses/nÞ 25; n, number of completed responses.
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Pearson’s r correlation coefficient of 0.973 ( p < 0:001) and a Spearman’s rho correlation coefficient of 0.971 ( p < 0:001). Respectively for the DASH: (mean scores SD: 68:72 21:84 versus 66:10 20:95, p ¼ 0:049, paired samples t test; median scores (interquartile range): 75.00 (50.52–82.76) versus 64.58 (45.99–78.33), p ¼ 0:033 Wilcoxon signed ranks test) — correlation analysis revealed an intra-class correlation coefficient of 0.966 (95% CI, 0.933–0.982; p < 0:001), a Pearson’s r correlation coefficient of 0.934 ( p < 0:001) and a Spearman’s correlation coefficient of 0.926 ( p < 0:001). We assessed the convergent validity of Hand20 by correlating its scores to DASH-GR and EQ-5D scores; a statistically significant positive correlation was found between the Hand20 and DASH scores (Pearson’s r correlation coefficient, 0.746, p < 0:001; Spearman’s correlation coefficient, 0.749, p < 0:001) and a statistically significant negative correlation between the Hand20 and EQ-5D scores (Pearson’s r correlation coefficient, 0.371, p < 0:001; Spearman’s correlation coefficient, 0.399, p < 0:001), indicating a strong correlation between Hand20 and the other two questionnaires. Concerning the responsiveness of Hand20, the results of treatment effect validity are still in the processing stage.
Age Differences No statistically significant correlation between the Hand20 score and age was found (Pearson’s r correlation coefficient, 0.063, p ¼ 0:468; Spearman’s correlation coefficient, 0.051, p ¼ 0:556).
Completeness of Item Responses Out of 134 patients, 3 (2.2%) did not answer three or more items of the Hand20 and 21 (14.2%) patients did not answer four or more items of the DASH. These ‘missing data’, were considered inappropriate cases in our study. The items with a high unanswered rate among all patients were Q12 ‘hang wet clothes on a clip hanger’ and Q17 ‘Do you experience difficulties in recreational activities like painting, knitting, sports’ for the Hand20 and Q4 ‘prepare a meal’, Q12 ‘change a light bulb overhead’, Q18 ‘recreational activities — Basketball and Tennis’, Q19 ‘recreational activities — swimming, playing volleyball’, Q21 ‘sexual activities’ and Q25 ‘Arm, shoulder or hand pain when you performed any specific activity like tennis or basketball’ for the DASH.
Table 3 Groups.
The Frequencies of Inappropriate Cases in the Three Age
Age Groups < 45 46–65 > 65 (n = 41) (n = 66) (n = 27) Frequencies of Hand20 inappropriate cases DASH
p
0%
3.0%
3.7%
p ¼ 0:498
7.3%
12.1%
29.6%
p ¼ 0:014
More men than women did not answer Q12 (11.9% of 42 male patients) of Hand20 and Q4 (23.8% of 42 patients), Q7 (11.9% of 42 patients) of DASH, while most women did not answer the Q12 (12% of 93 female patients) and Q21 (29.3% of 93 patients) of DASH-GR. There were significantly fewer inappropriate cases in Hand20 than in DASH (McNemar test, p < 0:001).
Completeness According to Age Furthermore, the patients were categorised into three age groups ( 45 years: 41 patients, 46–65 years: 66 patients and > 65 years: 27 patients). The frequencies of inappropriate cases in the three age groups were 0, 3.0 and 3.7% (p ¼ 0:498) of Hand20 and 7.3, 12.1 and 29.6 (p ¼ 0:014 for linear trend) of DASH (Table 3).
DISCUSSION In this study, Greek translation of the Hand20 questionnaire was performed following a systematic standardised approach. Hand20 is a Japanese illustrated questionnaire for disorders of the upper limb composed of 20 short, easy-to-understand questions accompanied by explanatory illustrations. It is a region specific instrument, the validation of which, was comparable with that of the Japanese version of the DASH (DASHJSSH) questionnaire as demonstrated by Suzuki et al.7 In the current study, Cronbach’s alpha value for the Hand20 was 0.956 indicating excellent internal consistency. The test–retest reliability and the limits of agreement of Hand20 were very satisfactory with an intra-class correlation coefficient of 0.986, a Pearson’s r correlation coefficient of 0.973 and a Spearman’s correlation coefficient of 0.971. Correlation with DASH and EQ-5D questionnaire outcomes were used to assess the concurrent and convergent validity of
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Hand Surg. 2015.20:33-38. Downloaded from www.worldscientific.com by FLINDERS UNIVERSITY LIBRARY on 02/07/15. For personal use only.
The Greek Version of the Hand20 Questionnaire
Hand20, with a Pearson’s r ¼ 0:746, Spearman’s ¼ 0:749 for the DASH and a Pearson’s r ¼ 0:371, Spearman’s ¼ 0:399 for the EQ-5D, indicating a strong correlation between Hand20 and the other two questionnaires. Regarding the completeness of items, Hand20 had significantly better rates of responses than DASH. Gender differences are obvious for several unanswered items for both questionnaires. Regarding the Hand20, items with a high unanswered rate among all patients were Q12 and Q17. More men than women did not answer Q12 (11.9% of 42 male patients) because the ‘hanging of wet clothes’ was considered to be a household, female task according to the Greek culture. Q17 remained unanswered, equally by men and women because ‘painting, knitting or sports’ are not common recreational activities for Greek people. For the DASH questionnaire Q18 ‘recreational activities — Basketball and Tennis’, Q19 ‘recreational activities — swimming, playing volleyball’, Q25 ‘Arm, shoulder or hand pain when you performed any specific activity like tennis or basketball’, detailed analysis suggested that patients did not answer these items not because of cultural differences, but because of lack of experience. In fact, items 18 and 19 and 25 were the most unanswered items for both genders, although there was a significant higher unanswered rate for female patients. A possible reason for this discrepancy is that, in Greece, women are much less interested in sports than men. Another example is item 12, which was frequently missed item only for women. In Greece the lighting equipment is usually a man’s job, while ‘preparing a meal’ (Q4) it is in principal a female’s task. In Greece as well as in many other countries, men may be socially rather than physically unable to cook or perform housework. Finally Q21 seems to be a question ‘taboo’ for both genders possessing the first place of missing data especially for women (29.3% of 93 female patients). The age classification of the participants in three groups ( 45 years: 41 patients, 46–65 years: 66 patients and > 65 years: 27 patients) showed that, Hand20 had better completion of items than DASH-GR in all age groups especially in the elderly group. In elderly people, the Hand20 had significantly better completion of items than DASH-GR (p ¼ 0:011), with the ‘taboo’ Q21 of DASH being the most unanswered item for this age group (6 out of 27 patients). The existing guidelines, point out the use of DASH questionnaire by patients between 18 and 65 years14 (The DASH
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outcome measure, 2010). Our findings show that patients with a wider range of age (between 18 and 77 years) respond better to Hand20 questionnaire. With an ageing population worldwide and the growing need for developing instruments to assess the health related quality of life of older people, this seems to be one of the most important results obtained by this study. Finally, a percentage of our patients who received various types of treatments (surgical intervention, pharmaceutical treatment, physiotherapy etc.) for their affected upper limb, are still under consideration in order to compare Hand20 scores as well as the functionality between patients with different states of disease. The responsiveness of Hand20 before and after treatment, is consequently still under investigation, with satisfactory results so far, a fact that has already been demonstrated in a recent study in patients with carpal tunnel syndrome.15 All the findings mentioned above, lead us to the conclusion that Hand20 is a practical and reliable instrument for the evaluation of a variety of unilateral upper limb disorders in Greek patients.
ACKNOWLEDGEMENTS The authors would like to acknowledge the precious contribution of the nursing personnel of outpatient’s department of Orthopedic Surgery Department, to this research. The authors are also very grateful to Dr. D. A. Verettas, Emeritus Professor of Orthopedics for his encouragement, as well as to all the patients who willingly gave their time to complete the various assessments.
References 1. EuroQol.org: http://www.euroqol.org/home.html. 2. Constant CR, Murley AH, A clinical method of functional assessment of the shoulder, Clin Orthop 214:160–164, 1987. 3. King GJ, Richards RR, Zuckerman JD et al., A standardized method for assessment of elbow function: Research committee, American shoulder and elbow surgeons, J Shoulder Elbow Surg 8:351–354, 1999. 4. Kirkley A, Griffin S, McLintock H, Ng L, The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability: The Western Ontario Shoulder Instability Index (WOSI), Am J Sports Med 26:764–772, 1998. 5. Levine DW, Simmons BP, Koris MJ et al., A self-administered questionnaire for the assessment of severity of symptoms and functional
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6.
7.
8.
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9.
10.
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status in carpal tunnel syndrome, J Bone Joint Surg [Am] 75-A:1585– 1592, 1993. Hudak PL, Amadio PC, Bombardier C, Development of an upper extremity outcome measure: The DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG), Am J Ind Med 29(6):602–608, 1996. Suzuki M, Kurimoto S, Shinohara T, Tatebe M, Imaeda T, Hirata H, Development and validation of an illustrated questionnaire to evaluate disabilities of the upper limb, J Bone Joint Surg Br 92(7):963–969, 2010. Imaeda T, Toh S, Nakao Y et al., Validation of the Japanese society for surgery of the hand version of the disability of the arm, shoulder, and hand questionnaire, J Orthop Sci 10:353–359, 2005. Guillemin F, Bombardier C, Beaton D, Cross-cultural adaptation of health-related quality of life measures: Literature review and proposed guidelines, J Clin Epidemiol 46:1417–1432, 1993. Guillemin F, Cross-cultural adaptation and validation of health status measures, Scand J Rheumatol 24:61–63, 1995.
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11. Rosales RS, Delgado EB, Diez de la Lastra-Bosch I, Evaluation of the Spanish version of the DASH and carpal tunnel syndrome health-related quality-of-life instruments: Cross-cultural adaptation process and reliability, J Hand Surg Am 27:334–343, 2002. 12. Dawson J, Carr A, Outcomes evaluation in orthopaedics, J Bone Joint Surg [Br] 83-B:313–315, 2001. 13. Beaton DE, Katz JN, Fossel AH et al., Measuring the whole or the parts?: validity, reliability, and responsiveness of the disabilities of the arm, shoulder and hand outcome measure in different regions of the upper extremity, J Hand Ther 14:128–146, 2001. 14. The DASH outcome measure: Frequently asked questions, Available at http://www.dash.iwh.on.ca/faq.htm (last accessed on 9 March 2010). 15. Iwatsuki K, Nishikawa K, Chaki M, Sato A, Morita A, Hirata H, Comparative responsiveness of the Hand 20 and the DASH-JSSH questionnaires to clinical changes after carpal tunnel release, J Hand Surg Eur 39:145–151, 2014.
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Hand Surgery, Vol. 20, No. 1 (2015) 33–38 © World Scientific Publishing Company DOI: 10.1142/S0218810415500045
THE GREEK VERSION OF THE HAND20 QUESTIONNAIRE: CROSSCULTURAL TRANSLATION, RELIABILITY AND CONSTRUCT VALIDITY Thomais Goula,‡ Athanasios Ververidis,*,‡ Grigorios Tripsianis,† Konstantinos Tilkeridis*,‡ and Georgios I. Drosos*,‡ Hand Surg. 2015.20:33-38. Downloaded from www.worldscientific.com by FLINDERS UNIVERSITY LIBRARY on 02/07/15. For personal use only.
*Department
of Orthopaedic Surgery of Medical Statistics, Medical School, Democritus University of Thrace 68100 Alexandroupolis, Greece †Department
‡
University General Hospital of Alexandroupolis 68100 Alexandroupolis, Greece
Received 19 June 2014; Revised 1 September 2014; Accepted 2 September 2014; Published 20 January 2015 ABSTRACT The English version of Hand20 questionnaire was translated into Greek and cultural adaptation was performed. The validity was assessed in 134 patients with a variety of upper limb disorders. A comparison of Hand20 and DASH was also performed. All patients completed EQ-5D, Hand20 and DASH questionnaire. Test–retest reliability was assessed in a subgroup of 37 patients. We assessed the convergent validity of Hand20 by correlating its scores to DASH and EQ-5D scores. We also compared the completeness of Hand20 and DASH. We found no statistically significant differences in Hand20 scores between the 1st and 2nd measurements as well as a strong correlation between Hand20 and the other two questionnaires. There were also better rates of response and fewer missing data even in elderly individuals. Keywords: Hand20; DASH; Upper Limb Disorders; Translation.
INTRODUCTION
between countries, given the wide socio-cultural diversity of the populations studied and the difficulties of international standardisation of instruments, all of which can radically affect the results. Several outcome measures for the evaluation of the functional status of the upper extremity have been developed. There are numerous questionnaires and scales that are easy to complete by patients before or after a treatment. Some of them describe the general health of the patient1 while some are jointspecific2,3 or disease-specific.4,5 However, choosing the most
Health status measures or instruments are questionnaires designed to measure specific aspects of health e.g. physical capacity, mental state, cognitive function or pain associated with disease. Appropriately selected health status measures by health personnel can also be used for purposes of policy and planning to evaluate the effects of clinical practice on clinical outcomes. At the European level, the major problem with all of the above health status measures is their comparability within and
Correspondence to: Dr. Thomais Goula, Zallogou 31, PC:67100, Xanthi, Greece. Tel: (þ30) 697-488-9349, (þ30) 254-102-1682, Fax: (þ30) 255-103-0369, E-mail: [email protected] 33
Hand Surg. 2015.20:33-38. Downloaded from www.worldscientific.com by FLINDERS UNIVERSITY LIBRARY on 02/07/15. For personal use only.
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appropriate tool for assessing every condition of an affected upper limb seems to be a difficult task. A widely accepted and most commonly used questionnaire nowadays is the Disability of the Arm Shoulder and Hand (DASH) Questionnaire6 — developed by the American Academy of Orthopaedic Surgeons (AAOS). It is a self-administered, region-specific instrument for measuring disabilities and symptoms of upper extremity disorders using a five-level Likert scale. Recently, Orthopaedic Surgeons of the Department of Hand Surgery in the Nagoya University, School of Medicine developed a new illustrated questionnaire for disorders of the upper limb composed of 20 short, easy-to-understand questions accompanied by explanatory illustrations (19 of the 20 questions).7 Their study showed that the Hand20 questionnaire provided validation comparable with that of the DASH Japanese version (DASH-JSSH)8 and that most patients even elderly participants with cognitive deterioration had no difficulty in completing the Hand20. The main purpose of our study was the translation and cross-cultural adaptation of the Hand20 for Greek patients with disorders of the upper limb. Secondarily, the Greek version of Hand20 was compared to the DASH version.
Table 1 Diseases and Injuries in Participants in the Study by Number. Diseases and Injuries
Number per Disorder
Entrapment neuropathy
Carpal Tunnel Syndrome 28 Ulnar Neuritis 3 De Quervain Syndrome 11
Stenosing tenosynovitis Osteoarthritis in the hand Extensor tendon injury Flexor tendon injury Shoulder pathology
Ganglion Hand fractures
Elbow fractures Forearm fractures
Humeral shaft fractures Miscellaneous
Rotator cuff pathology 10 Biceps tendonitis 3 Frozen shoulder 2 Other 16 Carpal bone fractures 4 Metacarpal fractures 2 Phalangeal fractures 1 Radial head fractures Distal radial fractures 9 distal ulnar fractures 2 Ulnar & radial fractures 1 Elbow bursitis 2 Hand tendonitis 2 Shoulder dislocation 3 Other 5
Total
Total 31 11 5 10 2 31
4 7
3 12
6 12
134
MATERIAL AND METHODS Patients The study was conducted on a total of 134 patients (92 (68.7%) females, 42 (31.3%) males; mean age: 51:72 14:78 years, range, 18–77 years) with a variety of upper limb disorders and with their symptoms being stable during the previous four weeks. They attended the outpatient’s department of the Orthopedic Surgery Department of our hospital, enrolled in a consecutive manner from February to September 2013. The inclusion criteria were (a) Greek native language, (b) unilateral disorder of the upper limb, (c) age above 18 years, (d) ability to complete questionnaires independently, (e) moderate to excellent general health condition (patients with chronic fatal diseases were excluded). The study protocols were reviewed and approved by the Ethics Committee of our hospital. Selected patients were given a description of the study as well as additional information about the completion of the
questionnaires. In Table 1, the diseases and injuries included in our study and their frequency, are presented.
Translation Procedure A Greek translation was made using a forward–backward translation protocol according to the guidelines of Guillemin et al.9,10 Two translations were made independently and translated backwards by two independent individuals whose native language was Greek but who were also proficient in English. These versions were compared with the original by a committee, composed of a methodologist, a health professional, a language professional, as well as of all translators (both forward and backward), and the final translation was made. The last step of the translation procedure was the pretesting on several patients (pilot study with 10 patients). No attempt was made to make cultural adaptations to the questionnaire because of the existing illustrations that facilitate the comprehension of
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The Greek Version of the Hand20 Questionnaire
Hand20 by Greek patients (as the pilot study showed), therefore, there is no assessment of concept equivalence and difficulty of the translation as recommended by Rosales et al.11
Hand Surg. 2015.20:33-38. Downloaded from www.worldscientific.com by FLINDERS UNIVERSITY LIBRARY on 02/07/15. For personal use only.
Assessment of Reliability and Validity After signing an informed consent, all patients completed the Greek version of Hand20, DASH and EQ-5D questionnaire during their first visit in the outpatient’s Orthopaedic Department of our hospital. The EQ-5D is a public domain quality of life questionnaire from the Euro-Qol group, which has been validated in a number of countries and cultural settings1 (EuroQol.org). It allows the participants to indicate their health state by indicating the most applicable statement in five parameters, including mobility. The EQ-5D also includes a visual analogue scale (VAS) which is a self-scoring measure of current health status from 0 (worst imaginable health state) to 100 (best imaginable health state). Reliability was investigated by examining the reproducibility and internal consistency based on the test–retest method.12,13 For this purpose, 37 patients scheduled for a surgical intervention of the upper limb, completed both Hand20 and DASH questionnaires twice, with one week interval. We assumed that the clinical status of these patients was unlikely to have a significant change before the presently scheduled surgery.
Statistical Analysis Statistical analysis of the data was performed using the Statistical Package for the Social Sciences (SPSS), version 19.0 (IBM). The scores of all questionnaires were expressed as the mean score standard deviation (SD) and as the median score with the interquartile range (25th to 75th percentile); qualitative variables were expressed as frequencies (and percentages). The normality of quantitative variables was tested with Kolmogorov–Smirnov test. The internal consistency of Hand20 and DASH was assessed using the Cronbach’s a coefficient. The test–retest reliability was analyzed using the intra-class correlation coefficient, Pearson’s r and Spearman’s correlation coefficients, paired samples t test and Wilcoxon signed ranks test in the subgroup of patients, who were re-examined and who had reported no significant change in the functional status of their affected upper limb during the period that had elapsed. The convergent validity of Hand20 was assessed by correlating their scores with
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other well-established questionnaires (DASH and EQ-5D), using Pearson’s r and Spearman’s correlation coefficients. The association of Hand20 with patients’ age was also examined by employing, Pearson’s r and Spearman’s correlation coefficients. The chi-square test was used to evaluate any potential association between quantitative variables. All tests were two tailed and statistical significance was considered for p values less than 0.05.
RESULTS Reliability and Validity The Cronbach’s alpha coefficient for the 20 items in Hand20 was high (a ¼ 0:956). When the alpha coefficient was calculated for each of the 20 items by eliminating each item one by one, the range was 0.952–0.957, and no item was found to change the internal consistency substantially. The alpha coefficient for the 30 items in DASH was also high (a ¼ 0:962, ranging from 0.959 to 0.962 when the 30 items were deleted one by one). Test–retest reliability of Hand20 was calculated based on the results of 37 patients (10 males; mean age: 51:497 11:64 years; with an interval of 7 days). The difference between the individual scores of the initial assessment and reassessment of the Hand20 ranged from 20.00 to 9.06, with a mean difference of 0:51 5:44. We found no statistically significant differences in Hand20 scores between the 1st and 2nd measurements (mean scores SD: 35:02 22:87 versus 35:53 23:67, p ¼ 0:573, paired samples t test; median scores (interquartile range): 30.77 (15.65–53.25) versus 30.00 (14.74– 56.00), p ¼ 0:884 Wilcoxon signed ranks test) (Table 2). Moreover, correlation analysis revealed an intra-class correlation coefficient of 0.986 (95% CI, 0.973–0.993; p < 0:001), a
Table 2 The Median and Range of Hand20 and DASH Scores*. Instrument Scale Hand20 (1st interview) n ¼ 134 Hand20 (2nd interview) n ¼ 37 DASH (1st interview) n ¼ 134 DASH (2nd interview) n ¼ 37
Median
Range
30.77 30.00 75.00 64.58
15.65–53.25 14.74–56.00 50.52–82.76 45.99–78.33
*Hand20 score, sum of n responses/n 10; DASH score, (sum of n responses/nÞ 25; n, number of completed responses.
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Pearson’s r correlation coefficient of 0.973 ( p < 0:001) and a Spearman’s rho correlation coefficient of 0.971 ( p < 0:001). Respectively for the DASH: (mean scores SD: 68:72 21:84 versus 66:10 20:95, p ¼ 0:049, paired samples t test; median scores (interquartile range): 75.00 (50.52–82.76) versus 64.58 (45.99–78.33), p ¼ 0:033 Wilcoxon signed ranks test) — correlation analysis revealed an intra-class correlation coefficient of 0.966 (95% CI, 0.933–0.982; p < 0:001), a Pearson’s r correlation coefficient of 0.934 ( p < 0:001) and a Spearman’s correlation coefficient of 0.926 ( p < 0:001). We assessed the convergent validity of Hand20 by correlating its scores to DASH-GR and EQ-5D scores; a statistically significant positive correlation was found between the Hand20 and DASH scores (Pearson’s r correlation coefficient, 0.746, p < 0:001; Spearman’s correlation coefficient, 0.749, p < 0:001) and a statistically significant negative correlation between the Hand20 and EQ-5D scores (Pearson’s r correlation coefficient, 0.371, p < 0:001; Spearman’s correlation coefficient, 0.399, p < 0:001), indicating a strong correlation between Hand20 and the other two questionnaires. Concerning the responsiveness of Hand20, the results of treatment effect validity are still in the processing stage.
Age Differences No statistically significant correlation between the Hand20 score and age was found (Pearson’s r correlation coefficient, 0.063, p ¼ 0:468; Spearman’s correlation coefficient, 0.051, p ¼ 0:556).
Completeness of Item Responses Out of 134 patients, 3 (2.2%) did not answer three or more items of the Hand20 and 21 (14.2%) patients did not answer four or more items of the DASH. These ‘missing data’, were considered inappropriate cases in our study. The items with a high unanswered rate among all patients were Q12 ‘hang wet clothes on a clip hanger’ and Q17 ‘Do you experience difficulties in recreational activities like painting, knitting, sports’ for the Hand20 and Q4 ‘prepare a meal’, Q12 ‘change a light bulb overhead’, Q18 ‘recreational activities — Basketball and Tennis’, Q19 ‘recreational activities — swimming, playing volleyball’, Q21 ‘sexual activities’ and Q25 ‘Arm, shoulder or hand pain when you performed any specific activity like tennis or basketball’ for the DASH.
Table 3 Groups.
The Frequencies of Inappropriate Cases in the Three Age
Age Groups < 45 46–65 > 65 (n = 41) (n = 66) (n = 27) Frequencies of Hand20 inappropriate cases DASH
p
0%
3.0%
3.7%
p ¼ 0:498
7.3%
12.1%
29.6%
p ¼ 0:014
More men than women did not answer Q12 (11.9% of 42 male patients) of Hand20 and Q4 (23.8% of 42 patients), Q7 (11.9% of 42 patients) of DASH, while most women did not answer the Q12 (12% of 93 female patients) and Q21 (29.3% of 93 patients) of DASH-GR. There were significantly fewer inappropriate cases in Hand20 than in DASH (McNemar test, p < 0:001).
Completeness According to Age Furthermore, the patients were categorised into three age groups ( 45 years: 41 patients, 46–65 years: 66 patients and > 65 years: 27 patients). The frequencies of inappropriate cases in the three age groups were 0, 3.0 and 3.7% (p ¼ 0:498) of Hand20 and 7.3, 12.1 and 29.6 (p ¼ 0:014 for linear trend) of DASH (Table 3).
DISCUSSION In this study, Greek translation of the Hand20 questionnaire was performed following a systematic standardised approach. Hand20 is a Japanese illustrated questionnaire for disorders of the upper limb composed of 20 short, easy-to-understand questions accompanied by explanatory illustrations. It is a region specific instrument, the validation of which, was comparable with that of the Japanese version of the DASH (DASHJSSH) questionnaire as demonstrated by Suzuki et al.7 In the current study, Cronbach’s alpha value for the Hand20 was 0.956 indicating excellent internal consistency. The test–retest reliability and the limits of agreement of Hand20 were very satisfactory with an intra-class correlation coefficient of 0.986, a Pearson’s r correlation coefficient of 0.973 and a Spearman’s correlation coefficient of 0.971. Correlation with DASH and EQ-5D questionnaire outcomes were used to assess the concurrent and convergent validity of
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The Greek Version of the Hand20 Questionnaire
Hand20, with a Pearson’s r ¼ 0:746, Spearman’s ¼ 0:749 for the DASH and a Pearson’s r ¼ 0:371, Spearman’s ¼ 0:399 for the EQ-5D, indicating a strong correlation between Hand20 and the other two questionnaires. Regarding the completeness of items, Hand20 had significantly better rates of responses than DASH. Gender differences are obvious for several unanswered items for both questionnaires. Regarding the Hand20, items with a high unanswered rate among all patients were Q12 and Q17. More men than women did not answer Q12 (11.9% of 42 male patients) because the ‘hanging of wet clothes’ was considered to be a household, female task according to the Greek culture. Q17 remained unanswered, equally by men and women because ‘painting, knitting or sports’ are not common recreational activities for Greek people. For the DASH questionnaire Q18 ‘recreational activities — Basketball and Tennis’, Q19 ‘recreational activities — swimming, playing volleyball’, Q25 ‘Arm, shoulder or hand pain when you performed any specific activity like tennis or basketball’, detailed analysis suggested that patients did not answer these items not because of cultural differences, but because of lack of experience. In fact, items 18 and 19 and 25 were the most unanswered items for both genders, although there was a significant higher unanswered rate for female patients. A possible reason for this discrepancy is that, in Greece, women are much less interested in sports than men. Another example is item 12, which was frequently missed item only for women. In Greece the lighting equipment is usually a man’s job, while ‘preparing a meal’ (Q4) it is in principal a female’s task. In Greece as well as in many other countries, men may be socially rather than physically unable to cook or perform housework. Finally Q21 seems to be a question ‘taboo’ for both genders possessing the first place of missing data especially for women (29.3% of 93 female patients). The age classification of the participants in three groups ( 45 years: 41 patients, 46–65 years: 66 patients and > 65 years: 27 patients) showed that, Hand20 had better completion of items than DASH-GR in all age groups especially in the elderly group. In elderly people, the Hand20 had significantly better completion of items than DASH-GR (p ¼ 0:011), with the ‘taboo’ Q21 of DASH being the most unanswered item for this age group (6 out of 27 patients). The existing guidelines, point out the use of DASH questionnaire by patients between 18 and 65 years14 (The DASH
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outcome measure, 2010). Our findings show that patients with a wider range of age (between 18 and 77 years) respond better to Hand20 questionnaire. With an ageing population worldwide and the growing need for developing instruments to assess the health related quality of life of older people, this seems to be one of the most important results obtained by this study. Finally, a percentage of our patients who received various types of treatments (surgical intervention, pharmaceutical treatment, physiotherapy etc.) for their affected upper limb, are still under consideration in order to compare Hand20 scores as well as the functionality between patients with different states of disease. The responsiveness of Hand20 before and after treatment, is consequently still under investigation, with satisfactory results so far, a fact that has already been demonstrated in a recent study in patients with carpal tunnel syndrome.15 All the findings mentioned above, lead us to the conclusion that Hand20 is a practical and reliable instrument for the evaluation of a variety of unilateral upper limb disorders in Greek patients.
ACKNOWLEDGEMENTS The authors would like to acknowledge the precious contribution of the nursing personnel of outpatient’s department of Orthopedic Surgery Department, to this research. The authors are also very grateful to Dr. D. A. Verettas, Emeritus Professor of Orthopedics for his encouragement, as well as to all the patients who willingly gave their time to complete the various assessments.
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status in carpal tunnel syndrome, J Bone Joint Surg [Am] 75-A:1585– 1592, 1993. Hudak PL, Amadio PC, Bombardier C, Development of an upper extremity outcome measure: The DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG), Am J Ind Med 29(6):602–608, 1996. Suzuki M, Kurimoto S, Shinohara T, Tatebe M, Imaeda T, Hirata H, Development and validation of an illustrated questionnaire to evaluate disabilities of the upper limb, J Bone Joint Surg Br 92(7):963–969, 2010. Imaeda T, Toh S, Nakao Y et al., Validation of the Japanese society for surgery of the hand version of the disability of the arm, shoulder, and hand questionnaire, J Orthop Sci 10:353–359, 2005. Guillemin F, Bombardier C, Beaton D, Cross-cultural adaptation of health-related quality of life measures: Literature review and proposed guidelines, J Clin Epidemiol 46:1417–1432, 1993. Guillemin F, Cross-cultural adaptation and validation of health status measures, Scand J Rheumatol 24:61–63, 1995.
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11. Rosales RS, Delgado EB, Diez de la Lastra-Bosch I, Evaluation of the Spanish version of the DASH and carpal tunnel syndrome health-related quality-of-life instruments: Cross-cultural adaptation process and reliability, J Hand Surg Am 27:334–343, 2002. 12. Dawson J, Carr A, Outcomes evaluation in orthopaedics, J Bone Joint Surg [Br] 83-B:313–315, 2001. 13. Beaton DE, Katz JN, Fossel AH et al., Measuring the whole or the parts?: validity, reliability, and responsiveness of the disabilities of the arm, shoulder and hand outcome measure in different regions of the upper extremity, J Hand Ther 14:128–146, 2001. 14. The DASH outcome measure: Frequently asked questions, Available at http://www.dash.iwh.on.ca/faq.htm (last accessed on 9 March 2010). 15. Iwatsuki K, Nishikawa K, Chaki M, Sato A, Morita A, Hirata H, Comparative responsiveness of the Hand 20 and the DASH-JSSH questionnaires to clinical changes after carpal tunnel release, J Hand Surg Eur 39:145–151, 2014.
