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Translation, cultural adaptation and reproducibility of a Portuguese version of the Functional Index for Hand OsteoArthritis (FIHOA)

Translation, cultural adaptation and reproducibility of a Portuguese version of the Functional... Background: The Functional Index for Hand Osteoarthritis (FIHOA) is a simple, reliable, and reproducible specific instrument to evaluate hand OA that can be applied both in clinical practice and research protocols. In order to be used in Brazil, FIHOA has to be translated into Portuguese, culturally adapted and have the reliability of the translated FIHOA version tested, which is the purpose of this study. Methods: The FIHOA was translated into Brazilian Portuguese and administered to 68 patients with hand OA recruited between May 2019 and February 2020. The test-retest was applied to 32 patients and the reliability was assessed using Spearman’s correlation coefficient and intraclass correlation coefficient (ICC). The internal consistency reliability was evaluated using Cronbach’s alpha. External construction validity was assessed using the Spearman’scorrelation test between FIHOA and pain, assessed with a Visual Analogue Scale (VAS), the Cochin Hand Functional Scale (CHFS) and Health Assessment Questionnaire (HAQ). Results: The 30 participants that initially answered the translated version of the FiHOA did not report difficulties in understanding or interpreting the translated version. The test-retest reliability for the total score was strong (r =0.86; ICC = 0.89). Mean differences (1.37 ± 0.68) using Bland Altman’s analysis did not significantly differ from zero and no systematic bias was observed. Cronbach’s alpha was also high (0.89) suggesting a strong internal coherence in the test items. There were also correlations between FIHOA and the CHFS (r =0.88), HAQ (r = 0.64) and pain in the hands both at rest (r =0.55) and in motion (r =0.44). Conclusion: The translation of the FIHOA into Brazilian Portuguese proved a valid instrument for measuring the functional capacity of patients with hand OA who understand Brazilian Portuguese. Keywords: FIHOA, Hand, Osteoarthritis, Patient health questionnaires, Validation studies * Correspondence: arocha@ufc.br Department of Internal Medicine - Faculdade de Medicina, Universidade Federal do Ceará, Fortaleza, CE, Brazil Instituto de Biomedicina – Laboratório de Investigação em Osteoartropatias, Rua Cel. Nunes de Melo, 1315 - 1°. Andar, Rodolfo Teófilo, Fortaleza, CE 60430-270, Brazil Full list of author information is available at the end of the article © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Azevedo et al. Advances in Rheumatology (2021) 61:30 Page 2 of 8 Background FIHOA was translated into Portuguese by two independ- Osteoarthritis (OA) is the most prevalent chronic ent native Portuguese-speaking persons. Minor differ- arthropathy, involving particularly the hands, knee, ences were observed between the versions of the texts of cervical and lumbar spine and the hip [1, 2]. This is also the 02 translators. The discrepancies between the trans- true in Brazil, as it was recently reported, indicating a lations were discussed with the translators and a consen- high OA prevalence [3]. Hand OA usually evolves with sus Portuguese translation was made. The consensus worsening symptoms with advanced age, being more Portuguese version was then translated back into English prevalent in women. It is most commonly bilateral with by two bilingual native English speakers that were un- symmetrical joint involvement [1, 4]. In addition to the aware of the original version. This consensus version pain component there is usually impairment of grip and was compared with the original questionnaire in order pinch function particularly in those with a severe form to assess semantic equivalence between the two versions [2, 4]. Initiatives published by the Outcome Measures in and thus confirm a final translated version of the ques- Rheumatology Clinical Trials (OMERACT) and Osteo- tionnaire. Following, the final version of the translated arthritis Research Society International (OARSI) recom- text was analyzed by three independent rheumatologists mend the application of function measures to evaluate and a physiotherapist, also native Portuguese speakers, hand OA [5, 6]. The Functional Index for Hand Osteo- reaching a final cross-culturally adapted Portuguese con- arthritis (FIHOA) is a free-of-charge, simple, reliable, sensus translation (Table 1). and reproducible specific instrument to evaluate hand OA that can be applied both in clinical practice and re- Patients search protocols [7, 8]. It has been originally published A total of 68 consecutive patients attending the outpatient in an English version and various translations into other clinic of the Rheumatology Service of the Hospital das languages have been provided [9–12]. In order to be Clínicas of the Faculdade de Medicina of the Universidade used in another language, a questionnaire has to be Federal do Ceará were recruited between May 2019 and translated, culturally adapted and validated [13]. Our February 2020. The protocol was approved by the Local aim was to translate, culturally adapt and test the reli- Ethics Committee (CAAE:07360819930015045; May 20, ability of a Portuguese version of the FIHOA. 2019) and all participants signed an informed consent prior to inclusion. Patients had to be native Portuguese Methodology speakers, within 40 to 75 years-old age range and meet the Translation and cultural adaptation classification criteria for Hand OA according to the The translation process was performed according to the American College of Rheumatology [14]. Exclusion cri- guidelines for validation and cross-cultural adaptation, teria included skin lesions restricting range of motion, as described previously [13]. The original version of crystal-related arthropathies (gout, calcium pyrophosphate Table 1 Portuguese version of the Functional Index for Hand Osteoarthritis Original version of FIHOA Portuguese version of FIHOA Question 1 Are you able to turn a key in a lock? Você consegue girar uma chave em uma fechadura? Question 2 Are you able to cut meat with a knife? Você consegue cortar a carne com uma faca? Question 3 Are you able to cut cloth or paper with a pair of scissors? Você consegue cortar tecido ou papel com uma tesoura? Question 4 Are you able to lift a full bottle with the hand? Você consegue levantar uma garrafa cheia com a mão? Question 5 Are you able to clench your fist? Você consegue fechar a sua mão totalmente? Question 6 Are you able to tie a knot? Você consegue dar um nó? Question 7A For women - Are you able to sew? Para mulheres – Você consegue costurar? Question 7B For men - Are you able to use a screwdriver? Para homens – Você consegue usar uma chave de fenda? Question 8 Are you able to fasten buttons? Você consegue abotoar uma roupa? Question 9 Are you able to write for a long period of time (10 min)? Você consegue escrever por um longo período de tempo? (10 min) Question 10 Would you accept a handshake without reluctance? Você aceitaria um aperto de mão sem medo? Scoring system 0 Possible without difficulty Possível sem dificuldade 1 Possible with slight difficulty Possível com pouca dificuldade 2 Possible with importante difficulty Possível com muita dificuldade 3 Impossible Impossível Azevedo et al. Advances in Rheumatology (2021) 61:30 Page 3 of 8 disease), other immune-mediated diseases (rheumatoid Health Assessment Questionnaire (HAQ) arthritis, spondyloarthropathies, Sjögren’s syndrome, sys- The HAQ is a validated scale to assess functional daily temic lupus erythematosus), hemochromatosis, history of living activities that can be used with arthritis patients upper limb trauma in the past 20 years, previous hand sur- and has been translated into Brazilian Portuguese (range gery, presence of a neurological disease or other musculo- 0–60) [16]. skeletal disease affecting the function of the upper limb. Initially, 30 participants with hand OA answered the Statistical analysis translated version of the questionnaire in order to assess All data were analyzed using the Statistical Package for the complete understanding of all items and whether the Social Science (SPSS) version 23 and the R program questions included the expected concepts without re- (version 3). A minimum sample size was defined as 50, dundancy. Questions that could not be understood by based on a 5:1 criterion considering at least 5 respon- more than 20% of the responders were analyzed, revised dents for each question, as described previously [17]. In and resubmitted to another 30 group of patients. This this case, a minimum of 50 respondents for the 10 ques- procedure would be repeated until all questions were tions FIHOA questionnaire. Demographic and clinical understood by over 80% of the patients in order to as- characteristics were described using the mean and stand- sure cultural adaptation. None of the participants re- ard deviation for continuous variables and percentages ported difficulty in understanding and interpreting the for categorical variables. The main variable analyzed was questions involved in the final Portuguese version of the total score of the sum of the instrument’s items. The FIHOA and the expert committee decided that no re- Wilcoxon test was used to compare FIHOA scores be- submission of the questionnaire to another group of par- tween test and retest. ticipants and no further adjustments were necessary. Subsequently, another group of patients was recruited to answer the questionnaire three times (test-retest Test-retest reliability phase). At first, participants were interviewed twice by The analysis of the intraclass correlation coefficient different evaluators to check for inter-observer reliability. (ICC), Spearman’s rank correlation coefficient and the The second interview was conducted between 7 and 15 Bland-Altman graph were used to assess inter-observer days after the first visit to assess intra-observer reliabil- and intra-observer reproducibility. A level of ICC ≥ 0.7 ity. All questionnaires were answered under the supervi- was considered strong at the scale level. Intraclass cor- sion of an interviewer. relation coefficients (ICCs) considering a 95% confidence interval (95% CI) were calculated for each isolated item as well as for total scores using a two-way random Functional Index for Hand Osteoarthritis score and other model. Spearman’s coefficient of 0.1–0.3, 0.31–0.5 and > measures 0.5 were considered weak, moderate and strong correl- FIHOA ation, respectively. The FIHOA contains 10 questions with one sex specific question included. The responses are scaled on a four- point Likert scale (0 = possible without difficulty, 1 = Internal consistency possible with slight difficulty, 2 = possible with important Cronbach’s alpha test was performed to assess the in- difficulty, 3 = impossible), to avoid any centralization of ternal consistency of FIHOA. This instrument was used the answers. The range of scores is 0 to 30 [6]. to measure the global correlation between items within the scale and levels > 0.7 were considered an adequate performance [16]. We calculated the total item correla- Visual Analogue Scale for Hand Pain tions adjusted for the specific item. A correlation of at Pain was assessed using a Visual Analogue Scale (VAS, least 0.4 was considered adequate to validate the internal 0–100 mm) for pain at rest and movement considering consistency of the scale. overall pain in the index hand during the last week. Cochin Hand Functional Scale (CHFS) Internal construct and external validity The CHFS is an instrument for assessing functional dis- Internal construction validity was assessed with analysis ability of the hands that was initially developed in France factor according to the standard “eigenvalue > 1” rule to be used in patients with rheumatoid arthritis. It consists (the Kaiser criterion). Spearman’s correlation test was of a questionnaire of 18 questions (range 0–90) about ac- used to verify the validity of external construction. tivities of daily living that has been applied in other dis- External validity was assessed with the correlation of eases involving the hand, including OA, and has been FIHOA with VAS of pain and the CHFS and HAQ translated and validated into Brazilian Portuguese [15]. instruments. Azevedo et al. Advances in Rheumatology (2021) 61:30 Page 4 of 8 Results Internal consistency Clinical and demographic characteristics A high (0.89) Cronbach’s alpha was achieved, meaning a The Portuguese version of FIHOA was applied to 68 pa- strong internal consistency between the test item. These tients. The average time to answer the questionnaire was values were also high even after deleting an item, ran- around 3 min. The clinical and demographic characteris- ging from 0.91 to 0.93, further confirming the internal tics are shown in Table 2. Initially, 30 participants with consistency of the translated version of the test. The in- hand OA answered the translated version of the ques- dividual items of the Brazilian version of FIHOA showed tionnaire in order to assess the complete understanding a moderate correlation adjusted to the total of the items. of all items and none of the participants reported diffi- All correlations were statistically significant (p < 0.01), as culty in understanding and interpreting the questions in- shown in Table 4. volved in the final Portuguese version of FIHOA. Following, the test-retest phase was performed with 38 Validity of internal construction participants. In this phase, six participants didn’t Factor analysis was performed to assess the internal complete the 1st FIHOA assessment (5 did not answer structural validity of the Brazilian version of FIHOA. item 7 and 1 did not answer question 7 and question 4) The Kaiser-Meyer-Olkin was 0.821, which suggests that and were excluded from the analysis (Table 2). the sample size was adequate. Bartlett’s sphericity test produced a high χ2 of 185.0 (P < 0.01), which indicates Test – retest reliability that the factorial model was appropriate. The selection The Portuguese version of FIHOA was applied on of two components represented 67.8% of the overall two occasions with an interval of 7 or 15 days. No variation. The two factors represented 54.3 and 13.4%, of statistically significant difference between the evalua- the total variation, respectively. tions was observed (Wilcoxon test: p = 0.32). The All 10 FIHOA items were positively correlated with average score of each item and the total score of the factor 1 (representing 54.3% of the variance). Therefore, FIHOA test-retest are reported in Table 3 showing factor 1 may reflect the general capacity to perform ac- no differences between the two evaluations. The tivities composing the FIHOA. The correlation model average of the total score of the FIHOA was 9.9 ± became clearer with the varimax rotation, establishing a 7.2 in the first assessment and 8.6 ± 6.5 in the sec- two-dimensional model for the Brazilian version of ond evaluation. The Spearman value for the total FIHOA. score was 0.86 and there was a variation for each The rotation suggested that the first factor captured item ranging from 0.4 to 0.8. The ICC of 0.89 for items such as activities that require coordination of the the total score was considered strong and the ICC fingers and activities related to holding objects for a long for each single item was considered good to strong period of time by pinching fingers. This factor also cap- (0.6–0.9) and ICC for interobserver, which was 0.92, tured activities that need to hold objects in the hand ap- was also strong. Mean differences (1.37 ± 0.68) using plying a higher level of force. The first factor consists of Bland Altman’s analysis did not significantly differ the following six items: item 4 (“Are you able to lift a full from zero and no systematic bias was observed, as bottle with the hand?”); item 6 (“Are you able to tie a illustrated in Fig. 1. knot?”); item 3 (“Are you able to cut cloth or paper with Table 2 Demographic and clinical characteristics of patients that answered the Portuguese version of the FIHOA questionnaire Variable Cultural adaptation (30) Test-retest (32) Total (62) Age (y) 51.7 ± 9.8 61.8 ± 10.1 56.9 ± 11.2 Female(%) 93 97 95 Duration of symptoms onset(m) 33.3 ± 44.1 131 ± 115 83.7 ± 100.8 Time of diagnosis(m) 17.2 ± 39.3 74.3 ± 101.6 46.7 ± 83 Right hand dominant (%) 97 100 98 FIHOA 4.6 ± 7.1 9.9 ± 7.2 7.4 ± 7.6 VAS 1 37.8 ± 28 VAS2 68.7 ± 25 CHFS 20.9 ± 15.9 HAQ 12.6 ± 8.37 A total of 62 patients answered a Portuguese version of the FIHOA questionnaire. Values represent n (%) of mean ± SD, as indicated. CHFS, Cochin Hand Functional Scale; HAQ, Health Assessment Questionnaire; y, years; m, months; SD, standard deviation; VAS (0–100 mm), visual analogue scale at rest (1) or following movement (2) Azevedo et al. Advances in Rheumatology (2021) 61:30 Page 5 of 8 Table 3 Test-retest of reliability of the Brazilian version of the FIHOA questionnaire FIHOA test -retest Test Retest Spearman’s rho ICC Item 1 – item 1 retest 0.53 ± 0.71 0.5 ± 0.62 0.66 0.81 Item 2 – item 2 retest 0.97 ± 0.88 0.87 ± 0.88 0.63 0.81 Item 3 – item 3 retest 0.97 ± 0.88 0.83 ± 0.82 0.73 0.84 Item 4 – item 4 retest 1.06 ± 0.90 0.97 ± 0.87 0.51 0.62 Item 5 – item 5 retest 1.09 ± 1.07 1.10 ± 1.08 0.76 0.90 Item 6 – item 6 retest 0.63 ± 0.74 0.63 ± 0.84 0.40 0.60 Item 7 – item 7 retest 0.97 ± 0.98 0.57 ± 0.67 0.65 0.80 Item 8 – item 8 retest 0.75 ± 0.83 0.57 ± 0.67 0.67 0.81 Item 9 – item 9 retest 1.56 ± 1.12 1.37 ± 1.11 0.80 0.87 Item 10 – item 10 retest 1.44 ± 1.12 1.2 ± 1.11 0.72 0.83 FIHOA Total Score 9.9 ± 7.2 8.6 ± 6.5 0.86 0.89 Values are given as mean ± standard deviation a pair of scissors?”); item 8 (“Are you able to fasten but- of hand pain at rest and in motion, CHFS and HAQ. tons?”); item 9 (“Are you able to write for a long period There was a strong direct correlation between of time?”) and item 2 (“Are you able to cut meat with a FIHOA and CHFS (Spearman’srho=0.89, P <0.01) knife?”). and moderate correlation for FIHOA and HAQ The second factor explains 13.4% of the total variance (Spearman’srho=0.64, P <0.01). There was also a and is made up of item 5 (“Are you able to clench your moderate correlation with VAS values for pain in fist?”), 1 (Are you able to turn a key in a lock?), 7 (“Are the hands at rest (Spearman’s rho = 0.55, P <0.01) you able to sew?” Or “Are you able to use a screw- and a moderate correlation with VAS values for pain driver?”) and 10 (would you accept a handshake without in the hands when in motion (Spearman’srho=0.44, reluctance?”). These activities seem to be particularly re- P <0.01). lated to the ability to perform rotation, flexion and ex- The Bland and Altman graph concerning the ana- tension of the wrist and hand grip movement. Item 7 lysis of the FIHOA x HAQ tools showed that the had a strong correlation with both factors (factor 1 (519) mean differences were distributed close to zero and and factor 2 (698)), meaning that the activity evaluated within 2 SD. Almost all observations were within the in item 7 is also related to the ability of coordinated fin- upper and lower limits identified by the SD, with only ger movements. Factor 2 was opposed from item 5 to 03 values differing from the mean in more than three item 8, suggesting that individuals who were able to SD. The Bland and Altman analysis of the FIHOA x close their hands more easily had a lot of difficulty in CHFS tools showed that the mean differences were performing the task of fastening buttons. close to 10, between 02 SD. Almost all observations were within the upper and lower limits identified by Validity of external construction the SD, and none differed from the mean by more We calculated Spearman’s rho values between the than three SD. No systematic trend of differences was total score of the Brazilian version of FIHOA, VAS observed in both analyzes. Fig. 1 Bland-Altman Plot of the Portuguese version of total FIHOA score for test and retest with 95% CI Azevedo et al. Advances in Rheumatology (2021) 61:30 Page 6 of 8 Table 4 Internal consistency of the Brazilian version of FIHOA Item Score Scale mean if Scale variance if Ajusted total Cronbach’s alpha if item is deleted item is deleted item correlation item is deleted Item 1 0.53 ± 0.71 9.44 46.06 0.726 0.918 Item 2 0.97 ± 0.88 9.00 42.97 0.839 0.911 Item 3 0.97 ± 0.88 9.00 43.61 0.778 0.914 Item 4 1.06 ± 0.90 8.91 43.77 0.748 0.915 Item 5 1.09 ± 1.07 8.88 46.05 0.434 0.934 Item 6 0.63 ± 0.74 9.34 45.85 0.711 0.918 Item 7 0.97 ± 0.98 9.00 42.45 0.783 0.913 Item 8 0.75 ± 0.83 9.22 44.95 0.707 0.918 Item 9 1.56 ± 1.12 8.41 40.51 0.821 0.911 Item 10 1.44 ± 1.12 8.53 41.93 0.710 0.918 Values are given as mean ± standard deviation Discussion a larger number of patients using VAS assessment at rest This study provides the Portuguese version of the FIHOA and movement can be carried out in the future to clarify questionnaire with cultural adaptation to Brazilian pa- the correlation of these two characteristics with the tients, demonstrating a good reliability, validity, and in- FIHOA score. ternal consistency in patients with hand OA. Cultural A good reliability was obtained given the good adaptation was not a major issue given the similarity of consistency of answers in the test-retest analysis which the meaning of each FIHOA items which can be consid- may be due to the clarity and simplicity of the questions ered very similar in any culture. Although we did not aim in the original FIHOA questionnaire, making it possible to compare total scores among our patients, our mean of to be easily translated. This aspect reinforces the validity 7.4, which could be considered revealing a moderate func- of applying FIHOA in our patients. tional impairment, are lower than values reported in simi- The strong internal consistency of this Portuguese ver- lar studies carried out in Belgium (10.9), Iran (9.9) and sion of FIHOA is illustrated by a high Cronbach’s alpha Norway (9.3) [10, 18, 19]. On the other hand, one may result. Cronbach’s alpha showed a slight increase if any consider that our patients presented greater impairment of the items were deleted and remained at a high value, when comparing to scores obtained in studies performing indicating that the items are suitable for use. The correl- translation of FIHOA in Italy (6.5), Japan (5.5), Morocco ation for adjusted item-total is> 0.4 for all items, con- (5.0) and Korea (4.4) [11, 12, 20, 21]. firming that there is a strong of association between We performed an assessment of the level of hand pain individual items and the remainder of the scale. at rest and movement, which had not been done in pre- Similar to most studies, the Factor of Analysis of this vious FIHOA validation studies. The average level of Portuguese version of FIHOA shows that it is not a one- pain at rest by VAS of the patients in this study was dimensional tool, as reported by Dreiser et al. [7]. In- 38.7 mm, similar to the average pain in the population deed, similar to results obtained when translating into assessed in other studies such as in Belgium (42.9), Italy Persian, we found 2 factors, whereas similar studies per- (35), Norway (41.7) and Korea (35.2) [9, 11, 12, 19]. The formed in Italy and Korea found a greater number of average level of global pain in moving hands (67.8) factors [10–12]. Remarkably, the Norwegian version of showed an important increase when compared to the FIHOA was the only one reporting only one dimension level of pain at rest in our study and the other validation [19]. Our results were also able to discriminate the two studies [9–12, 19, 21]. Although we initially thought that components, functions of the hands such as: 1) coordin- the level of pain in moving hands could be better corre- ation of the fingers and clamping objects at length and lated with the total score of a functional assessment in- 2) rotation, flexion and extension of the wrist and hand strument such as FIHOA, the results showed that there grip movement. Other aspects, such as the level of pain was a better correlation with the mean VAS score of in the hands, may have influenced the response pattern pain in the hands at rest (0.55) compared to the VAS of component 2, as most patients with a higher level of score of pain in the hands in motion (0.44) although the disability in item 10 had a higher level of pain measured latter still has a moderate level of correlation. Actually, with the VAS. patients report that type of movement and intensity of The validity of external consistency was also consid- the force applied influence the level of pain. Studies with ered good when compared to other instruments that Azevedo et al. Advances in Rheumatology (2021) 61:30 Page 7 of 8 assess functionality such as HAQ and CHFS. Even in Society International; OMERACT: Outcome Measures in Rheumatology Clinical Trials; VAS: Visual Analogue Scale comparison with instruments that assess pain level (VAS of pain in hands at rest and in movement), the analysis Acknowledgements showed a good level of external correlation. We acknowledge partial support of this work from the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPQ), Brasil – Grant 308429/ This study has some limitations, including the rela- 2018-4. tively low number of patients. We also had only 3 male patients (5%), which preclude a reliable analysis of item Authors’ contributions 7b, judged to be specific to that gender. It is worth men- FVAA, JN, and FACR conceived the article. Data acquisition, analysis and/or interpretation: FVAA, AJ, HALR, JN, FACR. Draft and revision of the work: tioning that hand OA is very predominant in females FVAA, AJ, HALR, JN, FACR. All authors approved the final version of the and most previous similar FIHOA translational studies manuscript. All authors are accountable for all aspects of the work also had a similar low prevalence of male participants [9, particularly regarding integrity of the data and collection of material. 11, 12, 19, 22, 23]. There was a mean 10-year difference Funding between the groups that participated in the pre-test and This study received partial support of this work from the Conselho Nacional test-retest phases. The selection was at random and we de Desenvolvimento Científico e Tecnológico (CNPQ), Brasil – Grant 308429/ believe this difference was irrelevant since the under- 2018–4. standing of the phrasing was similar between both Availability of data and materials groups. All data generated or analysed during this study are included in this The evaluation of hand functionality through gender- published article. specific questions can have its added value quite ques- Declarations tionable in societies where a high and growing number of individuals of both genders have been performing Ethics approval and consent to participate similar tasks in their daily lives. It is assumed that there This work was fully compliant with Ethical Standards and receive approval from an Ethics Review Board accredited by the Conselho Nacional de Ética is a greater influence of a socio-cultural aspect than a em Pesquisa – Brasil (Ethics Approval: CAAE:07360819930015045; May 20, functional difference between the two specific questions 2019). for each gender. Further studies are needed to investi- Consent for publication gate whether this gender-specific issue can be eliminated Not applicable or replaced. Neither did we assess the number and loca- tion of the affected joints, nor the presence of Heberden Competing interests and Bouchard nodes and deformities caused by OA, The author and co-authors declare that there are no conflicts of interest to disclose concerning the publication of this article. which may influence dexterity and functional capacity of the fingers. Indeed, the number of nodes in the hands Author details and involvement of the base of the thumb and wrists Department of Internal Medicine - Faculdade de Medicina, Universidade Federal do Ceará, Fortaleza, CE, Brazil. Department of Global Health and may be associated with a higher level of pain and func- Population, Harvard T. H. Chan School of Public Health, Boston, MA, USA. tional limitation [19, 24–26]. Six patients didn’t Department of Community Health, Federal University of Ceará, Fortaleza, CE, complete the 1st FIHOA assessment, leaving some blank Brazil. Division of Rheumatology – Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil. Instituto de Biomedicina – items in the questionnaire and were excluded from the Laboratório de Investigação em Osteoartropatias, Rua Cel. Nunes de Melo, analysis. The answers were similar and they justified that 1315 - 1°. Andar, Rodolfo Teófilo, Fortaleza, CE 60430-270, Brazil. they hadn’t performed that task in many years or had Received: 26 January 2021 Accepted: 20 May 2021 never done it (06 patients didn’t know how to sew) and one patient also didn’t know how to answer question 4 and justified that this item didn’t specify the weight of References the bottle that he would try to lift. 1. Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010; 26(3):355–69. https://doi.org/10.1016/j.cger.2010.03.001. 2. Bijsterbosch J, Watt I, Meulenbelt I, Rosendaal FR, Huizinga TWJ, Kloppenburg M. 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Translation, cultural adaptation and reproducibility of a Portuguese version of the Functional Index for Hand OsteoArthritis (FIHOA)

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Abstract

Background: The Functional Index for Hand Osteoarthritis (FIHOA) is a simple, reliable, and reproducible specific instrument to evaluate hand OA that can be applied both in clinical practice and research protocols. In order to be used in Brazil, FIHOA has to be translated into Portuguese, culturally adapted and have the reliability of the translated FIHOA version tested, which is the purpose of this study. Methods: The FIHOA was translated into Brazilian Portuguese and administered to 68 patients with hand OA recruited between May 2019 and February 2020. The test-retest was applied to 32 patients and the reliability was assessed using Spearman’s correlation coefficient and intraclass correlation coefficient (ICC). The internal consistency reliability was evaluated using Cronbach’s alpha. External construction validity was assessed using the Spearman’scorrelation test between FIHOA and pain, assessed with a Visual Analogue Scale (VAS), the Cochin Hand Functional Scale (CHFS) and Health Assessment Questionnaire (HAQ). Results: The 30 participants that initially answered the translated version of the FiHOA did not report difficulties in understanding or interpreting the translated version. The test-retest reliability for the total score was strong (r =0.86; ICC = 0.89). Mean differences (1.37 ± 0.68) using Bland Altman’s analysis did not significantly differ from zero and no systematic bias was observed. Cronbach’s alpha was also high (0.89) suggesting a strong internal coherence in the test items. There were also correlations between FIHOA and the CHFS (r =0.88), HAQ (r = 0.64) and pain in the hands both at rest (r =0.55) and in motion (r =0.44). Conclusion: The translation of the FIHOA into Brazilian Portuguese proved a valid instrument for measuring the functional capacity of patients with hand OA who understand Brazilian Portuguese. Keywords: FIHOA, Hand, Osteoarthritis, Patient health questionnaires, Validation studies * Correspondence: arocha@ufc.br Department of Internal Medicine - Faculdade de Medicina, Universidade Federal do Ceará, Fortaleza, CE, Brazil Instituto de Biomedicina – Laboratório de Investigação em Osteoartropatias, Rua Cel. Nunes de Melo, 1315 - 1°. Andar, Rodolfo Teófilo, Fortaleza, CE 60430-270, Brazil Full list of author information is available at the end of the article © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Azevedo et al. Advances in Rheumatology (2021) 61:30 Page 2 of 8 Background FIHOA was translated into Portuguese by two independ- Osteoarthritis (OA) is the most prevalent chronic ent native Portuguese-speaking persons. Minor differ- arthropathy, involving particularly the hands, knee, ences were observed between the versions of the texts of cervical and lumbar spine and the hip [1, 2]. This is also the 02 translators. The discrepancies between the trans- true in Brazil, as it was recently reported, indicating a lations were discussed with the translators and a consen- high OA prevalence [3]. Hand OA usually evolves with sus Portuguese translation was made. The consensus worsening symptoms with advanced age, being more Portuguese version was then translated back into English prevalent in women. It is most commonly bilateral with by two bilingual native English speakers that were un- symmetrical joint involvement [1, 4]. In addition to the aware of the original version. This consensus version pain component there is usually impairment of grip and was compared with the original questionnaire in order pinch function particularly in those with a severe form to assess semantic equivalence between the two versions [2, 4]. Initiatives published by the Outcome Measures in and thus confirm a final translated version of the ques- Rheumatology Clinical Trials (OMERACT) and Osteo- tionnaire. Following, the final version of the translated arthritis Research Society International (OARSI) recom- text was analyzed by three independent rheumatologists mend the application of function measures to evaluate and a physiotherapist, also native Portuguese speakers, hand OA [5, 6]. The Functional Index for Hand Osteo- reaching a final cross-culturally adapted Portuguese con- arthritis (FIHOA) is a free-of-charge, simple, reliable, sensus translation (Table 1). and reproducible specific instrument to evaluate hand OA that can be applied both in clinical practice and re- Patients search protocols [7, 8]. It has been originally published A total of 68 consecutive patients attending the outpatient in an English version and various translations into other clinic of the Rheumatology Service of the Hospital das languages have been provided [9–12]. In order to be Clínicas of the Faculdade de Medicina of the Universidade used in another language, a questionnaire has to be Federal do Ceará were recruited between May 2019 and translated, culturally adapted and validated [13]. Our February 2020. The protocol was approved by the Local aim was to translate, culturally adapt and test the reli- Ethics Committee (CAAE:07360819930015045; May 20, ability of a Portuguese version of the FIHOA. 2019) and all participants signed an informed consent prior to inclusion. Patients had to be native Portuguese Methodology speakers, within 40 to 75 years-old age range and meet the Translation and cultural adaptation classification criteria for Hand OA according to the The translation process was performed according to the American College of Rheumatology [14]. Exclusion cri- guidelines for validation and cross-cultural adaptation, teria included skin lesions restricting range of motion, as described previously [13]. The original version of crystal-related arthropathies (gout, calcium pyrophosphate Table 1 Portuguese version of the Functional Index for Hand Osteoarthritis Original version of FIHOA Portuguese version of FIHOA Question 1 Are you able to turn a key in a lock? Você consegue girar uma chave em uma fechadura? Question 2 Are you able to cut meat with a knife? Você consegue cortar a carne com uma faca? Question 3 Are you able to cut cloth or paper with a pair of scissors? Você consegue cortar tecido ou papel com uma tesoura? Question 4 Are you able to lift a full bottle with the hand? Você consegue levantar uma garrafa cheia com a mão? Question 5 Are you able to clench your fist? Você consegue fechar a sua mão totalmente? Question 6 Are you able to tie a knot? Você consegue dar um nó? Question 7A For women - Are you able to sew? Para mulheres – Você consegue costurar? Question 7B For men - Are you able to use a screwdriver? Para homens – Você consegue usar uma chave de fenda? Question 8 Are you able to fasten buttons? Você consegue abotoar uma roupa? Question 9 Are you able to write for a long period of time (10 min)? Você consegue escrever por um longo período de tempo? (10 min) Question 10 Would you accept a handshake without reluctance? Você aceitaria um aperto de mão sem medo? Scoring system 0 Possible without difficulty Possível sem dificuldade 1 Possible with slight difficulty Possível com pouca dificuldade 2 Possible with importante difficulty Possível com muita dificuldade 3 Impossible Impossível Azevedo et al. Advances in Rheumatology (2021) 61:30 Page 3 of 8 disease), other immune-mediated diseases (rheumatoid Health Assessment Questionnaire (HAQ) arthritis, spondyloarthropathies, Sjögren’s syndrome, sys- The HAQ is a validated scale to assess functional daily temic lupus erythematosus), hemochromatosis, history of living activities that can be used with arthritis patients upper limb trauma in the past 20 years, previous hand sur- and has been translated into Brazilian Portuguese (range gery, presence of a neurological disease or other musculo- 0–60) [16]. skeletal disease affecting the function of the upper limb. Initially, 30 participants with hand OA answered the Statistical analysis translated version of the questionnaire in order to assess All data were analyzed using the Statistical Package for the complete understanding of all items and whether the Social Science (SPSS) version 23 and the R program questions included the expected concepts without re- (version 3). A minimum sample size was defined as 50, dundancy. Questions that could not be understood by based on a 5:1 criterion considering at least 5 respon- more than 20% of the responders were analyzed, revised dents for each question, as described previously [17]. In and resubmitted to another 30 group of patients. This this case, a minimum of 50 respondents for the 10 ques- procedure would be repeated until all questions were tions FIHOA questionnaire. Demographic and clinical understood by over 80% of the patients in order to as- characteristics were described using the mean and stand- sure cultural adaptation. None of the participants re- ard deviation for continuous variables and percentages ported difficulty in understanding and interpreting the for categorical variables. The main variable analyzed was questions involved in the final Portuguese version of the total score of the sum of the instrument’s items. The FIHOA and the expert committee decided that no re- Wilcoxon test was used to compare FIHOA scores be- submission of the questionnaire to another group of par- tween test and retest. ticipants and no further adjustments were necessary. Subsequently, another group of patients was recruited to answer the questionnaire three times (test-retest Test-retest reliability phase). At first, participants were interviewed twice by The analysis of the intraclass correlation coefficient different evaluators to check for inter-observer reliability. (ICC), Spearman’s rank correlation coefficient and the The second interview was conducted between 7 and 15 Bland-Altman graph were used to assess inter-observer days after the first visit to assess intra-observer reliabil- and intra-observer reproducibility. A level of ICC ≥ 0.7 ity. All questionnaires were answered under the supervi- was considered strong at the scale level. Intraclass cor- sion of an interviewer. relation coefficients (ICCs) considering a 95% confidence interval (95% CI) were calculated for each isolated item as well as for total scores using a two-way random Functional Index for Hand Osteoarthritis score and other model. Spearman’s coefficient of 0.1–0.3, 0.31–0.5 and > measures 0.5 were considered weak, moderate and strong correl- FIHOA ation, respectively. The FIHOA contains 10 questions with one sex specific question included. The responses are scaled on a four- point Likert scale (0 = possible without difficulty, 1 = Internal consistency possible with slight difficulty, 2 = possible with important Cronbach’s alpha test was performed to assess the in- difficulty, 3 = impossible), to avoid any centralization of ternal consistency of FIHOA. This instrument was used the answers. The range of scores is 0 to 30 [6]. to measure the global correlation between items within the scale and levels > 0.7 were considered an adequate performance [16]. We calculated the total item correla- Visual Analogue Scale for Hand Pain tions adjusted for the specific item. A correlation of at Pain was assessed using a Visual Analogue Scale (VAS, least 0.4 was considered adequate to validate the internal 0–100 mm) for pain at rest and movement considering consistency of the scale. overall pain in the index hand during the last week. Cochin Hand Functional Scale (CHFS) Internal construct and external validity The CHFS is an instrument for assessing functional dis- Internal construction validity was assessed with analysis ability of the hands that was initially developed in France factor according to the standard “eigenvalue > 1” rule to be used in patients with rheumatoid arthritis. It consists (the Kaiser criterion). Spearman’s correlation test was of a questionnaire of 18 questions (range 0–90) about ac- used to verify the validity of external construction. tivities of daily living that has been applied in other dis- External validity was assessed with the correlation of eases involving the hand, including OA, and has been FIHOA with VAS of pain and the CHFS and HAQ translated and validated into Brazilian Portuguese [15]. instruments. Azevedo et al. Advances in Rheumatology (2021) 61:30 Page 4 of 8 Results Internal consistency Clinical and demographic characteristics A high (0.89) Cronbach’s alpha was achieved, meaning a The Portuguese version of FIHOA was applied to 68 pa- strong internal consistency between the test item. These tients. The average time to answer the questionnaire was values were also high even after deleting an item, ran- around 3 min. The clinical and demographic characteris- ging from 0.91 to 0.93, further confirming the internal tics are shown in Table 2. Initially, 30 participants with consistency of the translated version of the test. The in- hand OA answered the translated version of the ques- dividual items of the Brazilian version of FIHOA showed tionnaire in order to assess the complete understanding a moderate correlation adjusted to the total of the items. of all items and none of the participants reported diffi- All correlations were statistically significant (p < 0.01), as culty in understanding and interpreting the questions in- shown in Table 4. volved in the final Portuguese version of FIHOA. Following, the test-retest phase was performed with 38 Validity of internal construction participants. In this phase, six participants didn’t Factor analysis was performed to assess the internal complete the 1st FIHOA assessment (5 did not answer structural validity of the Brazilian version of FIHOA. item 7 and 1 did not answer question 7 and question 4) The Kaiser-Meyer-Olkin was 0.821, which suggests that and were excluded from the analysis (Table 2). the sample size was adequate. Bartlett’s sphericity test produced a high χ2 of 185.0 (P < 0.01), which indicates Test – retest reliability that the factorial model was appropriate. The selection The Portuguese version of FIHOA was applied on of two components represented 67.8% of the overall two occasions with an interval of 7 or 15 days. No variation. The two factors represented 54.3 and 13.4%, of statistically significant difference between the evalua- the total variation, respectively. tions was observed (Wilcoxon test: p = 0.32). The All 10 FIHOA items were positively correlated with average score of each item and the total score of the factor 1 (representing 54.3% of the variance). Therefore, FIHOA test-retest are reported in Table 3 showing factor 1 may reflect the general capacity to perform ac- no differences between the two evaluations. The tivities composing the FIHOA. The correlation model average of the total score of the FIHOA was 9.9 ± became clearer with the varimax rotation, establishing a 7.2 in the first assessment and 8.6 ± 6.5 in the sec- two-dimensional model for the Brazilian version of ond evaluation. The Spearman value for the total FIHOA. score was 0.86 and there was a variation for each The rotation suggested that the first factor captured item ranging from 0.4 to 0.8. The ICC of 0.89 for items such as activities that require coordination of the the total score was considered strong and the ICC fingers and activities related to holding objects for a long for each single item was considered good to strong period of time by pinching fingers. This factor also cap- (0.6–0.9) and ICC for interobserver, which was 0.92, tured activities that need to hold objects in the hand ap- was also strong. Mean differences (1.37 ± 0.68) using plying a higher level of force. The first factor consists of Bland Altman’s analysis did not significantly differ the following six items: item 4 (“Are you able to lift a full from zero and no systematic bias was observed, as bottle with the hand?”); item 6 (“Are you able to tie a illustrated in Fig. 1. knot?”); item 3 (“Are you able to cut cloth or paper with Table 2 Demographic and clinical characteristics of patients that answered the Portuguese version of the FIHOA questionnaire Variable Cultural adaptation (30) Test-retest (32) Total (62) Age (y) 51.7 ± 9.8 61.8 ± 10.1 56.9 ± 11.2 Female(%) 93 97 95 Duration of symptoms onset(m) 33.3 ± 44.1 131 ± 115 83.7 ± 100.8 Time of diagnosis(m) 17.2 ± 39.3 74.3 ± 101.6 46.7 ± 83 Right hand dominant (%) 97 100 98 FIHOA 4.6 ± 7.1 9.9 ± 7.2 7.4 ± 7.6 VAS 1 37.8 ± 28 VAS2 68.7 ± 25 CHFS 20.9 ± 15.9 HAQ 12.6 ± 8.37 A total of 62 patients answered a Portuguese version of the FIHOA questionnaire. Values represent n (%) of mean ± SD, as indicated. CHFS, Cochin Hand Functional Scale; HAQ, Health Assessment Questionnaire; y, years; m, months; SD, standard deviation; VAS (0–100 mm), visual analogue scale at rest (1) or following movement (2) Azevedo et al. Advances in Rheumatology (2021) 61:30 Page 5 of 8 Table 3 Test-retest of reliability of the Brazilian version of the FIHOA questionnaire FIHOA test -retest Test Retest Spearman’s rho ICC Item 1 – item 1 retest 0.53 ± 0.71 0.5 ± 0.62 0.66 0.81 Item 2 – item 2 retest 0.97 ± 0.88 0.87 ± 0.88 0.63 0.81 Item 3 – item 3 retest 0.97 ± 0.88 0.83 ± 0.82 0.73 0.84 Item 4 – item 4 retest 1.06 ± 0.90 0.97 ± 0.87 0.51 0.62 Item 5 – item 5 retest 1.09 ± 1.07 1.10 ± 1.08 0.76 0.90 Item 6 – item 6 retest 0.63 ± 0.74 0.63 ± 0.84 0.40 0.60 Item 7 – item 7 retest 0.97 ± 0.98 0.57 ± 0.67 0.65 0.80 Item 8 – item 8 retest 0.75 ± 0.83 0.57 ± 0.67 0.67 0.81 Item 9 – item 9 retest 1.56 ± 1.12 1.37 ± 1.11 0.80 0.87 Item 10 – item 10 retest 1.44 ± 1.12 1.2 ± 1.11 0.72 0.83 FIHOA Total Score 9.9 ± 7.2 8.6 ± 6.5 0.86 0.89 Values are given as mean ± standard deviation a pair of scissors?”); item 8 (“Are you able to fasten but- of hand pain at rest and in motion, CHFS and HAQ. tons?”); item 9 (“Are you able to write for a long period There was a strong direct correlation between of time?”) and item 2 (“Are you able to cut meat with a FIHOA and CHFS (Spearman’srho=0.89, P <0.01) knife?”). and moderate correlation for FIHOA and HAQ The second factor explains 13.4% of the total variance (Spearman’srho=0.64, P <0.01). There was also a and is made up of item 5 (“Are you able to clench your moderate correlation with VAS values for pain in fist?”), 1 (Are you able to turn a key in a lock?), 7 (“Are the hands at rest (Spearman’s rho = 0.55, P <0.01) you able to sew?” Or “Are you able to use a screw- and a moderate correlation with VAS values for pain driver?”) and 10 (would you accept a handshake without in the hands when in motion (Spearman’srho=0.44, reluctance?”). These activities seem to be particularly re- P <0.01). lated to the ability to perform rotation, flexion and ex- The Bland and Altman graph concerning the ana- tension of the wrist and hand grip movement. Item 7 lysis of the FIHOA x HAQ tools showed that the had a strong correlation with both factors (factor 1 (519) mean differences were distributed close to zero and and factor 2 (698)), meaning that the activity evaluated within 2 SD. Almost all observations were within the in item 7 is also related to the ability of coordinated fin- upper and lower limits identified by the SD, with only ger movements. Factor 2 was opposed from item 5 to 03 values differing from the mean in more than three item 8, suggesting that individuals who were able to SD. The Bland and Altman analysis of the FIHOA x close their hands more easily had a lot of difficulty in CHFS tools showed that the mean differences were performing the task of fastening buttons. close to 10, between 02 SD. Almost all observations were within the upper and lower limits identified by Validity of external construction the SD, and none differed from the mean by more We calculated Spearman’s rho values between the than three SD. No systematic trend of differences was total score of the Brazilian version of FIHOA, VAS observed in both analyzes. Fig. 1 Bland-Altman Plot of the Portuguese version of total FIHOA score for test and retest with 95% CI Azevedo et al. Advances in Rheumatology (2021) 61:30 Page 6 of 8 Table 4 Internal consistency of the Brazilian version of FIHOA Item Score Scale mean if Scale variance if Ajusted total Cronbach’s alpha if item is deleted item is deleted item correlation item is deleted Item 1 0.53 ± 0.71 9.44 46.06 0.726 0.918 Item 2 0.97 ± 0.88 9.00 42.97 0.839 0.911 Item 3 0.97 ± 0.88 9.00 43.61 0.778 0.914 Item 4 1.06 ± 0.90 8.91 43.77 0.748 0.915 Item 5 1.09 ± 1.07 8.88 46.05 0.434 0.934 Item 6 0.63 ± 0.74 9.34 45.85 0.711 0.918 Item 7 0.97 ± 0.98 9.00 42.45 0.783 0.913 Item 8 0.75 ± 0.83 9.22 44.95 0.707 0.918 Item 9 1.56 ± 1.12 8.41 40.51 0.821 0.911 Item 10 1.44 ± 1.12 8.53 41.93 0.710 0.918 Values are given as mean ± standard deviation Discussion a larger number of patients using VAS assessment at rest This study provides the Portuguese version of the FIHOA and movement can be carried out in the future to clarify questionnaire with cultural adaptation to Brazilian pa- the correlation of these two characteristics with the tients, demonstrating a good reliability, validity, and in- FIHOA score. ternal consistency in patients with hand OA. Cultural A good reliability was obtained given the good adaptation was not a major issue given the similarity of consistency of answers in the test-retest analysis which the meaning of each FIHOA items which can be consid- may be due to the clarity and simplicity of the questions ered very similar in any culture. Although we did not aim in the original FIHOA questionnaire, making it possible to compare total scores among our patients, our mean of to be easily translated. This aspect reinforces the validity 7.4, which could be considered revealing a moderate func- of applying FIHOA in our patients. tional impairment, are lower than values reported in simi- The strong internal consistency of this Portuguese ver- lar studies carried out in Belgium (10.9), Iran (9.9) and sion of FIHOA is illustrated by a high Cronbach’s alpha Norway (9.3) [10, 18, 19]. On the other hand, one may result. Cronbach’s alpha showed a slight increase if any consider that our patients presented greater impairment of the items were deleted and remained at a high value, when comparing to scores obtained in studies performing indicating that the items are suitable for use. The correl- translation of FIHOA in Italy (6.5), Japan (5.5), Morocco ation for adjusted item-total is> 0.4 for all items, con- (5.0) and Korea (4.4) [11, 12, 20, 21]. firming that there is a strong of association between We performed an assessment of the level of hand pain individual items and the remainder of the scale. at rest and movement, which had not been done in pre- Similar to most studies, the Factor of Analysis of this vious FIHOA validation studies. The average level of Portuguese version of FIHOA shows that it is not a one- pain at rest by VAS of the patients in this study was dimensional tool, as reported by Dreiser et al. [7]. In- 38.7 mm, similar to the average pain in the population deed, similar to results obtained when translating into assessed in other studies such as in Belgium (42.9), Italy Persian, we found 2 factors, whereas similar studies per- (35), Norway (41.7) and Korea (35.2) [9, 11, 12, 19]. The formed in Italy and Korea found a greater number of average level of global pain in moving hands (67.8) factors [10–12]. Remarkably, the Norwegian version of showed an important increase when compared to the FIHOA was the only one reporting only one dimension level of pain at rest in our study and the other validation [19]. Our results were also able to discriminate the two studies [9–12, 19, 21]. Although we initially thought that components, functions of the hands such as: 1) coordin- the level of pain in moving hands could be better corre- ation of the fingers and clamping objects at length and lated with the total score of a functional assessment in- 2) rotation, flexion and extension of the wrist and hand strument such as FIHOA, the results showed that there grip movement. Other aspects, such as the level of pain was a better correlation with the mean VAS score of in the hands, may have influenced the response pattern pain in the hands at rest (0.55) compared to the VAS of component 2, as most patients with a higher level of score of pain in the hands in motion (0.44) although the disability in item 10 had a higher level of pain measured latter still has a moderate level of correlation. Actually, with the VAS. patients report that type of movement and intensity of The validity of external consistency was also consid- the force applied influence the level of pain. Studies with ered good when compared to other instruments that Azevedo et al. Advances in Rheumatology (2021) 61:30 Page 7 of 8 assess functionality such as HAQ and CHFS. Even in Society International; OMERACT: Outcome Measures in Rheumatology Clinical Trials; VAS: Visual Analogue Scale comparison with instruments that assess pain level (VAS of pain in hands at rest and in movement), the analysis Acknowledgements showed a good level of external correlation. We acknowledge partial support of this work from the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPQ), Brasil – Grant 308429/ This study has some limitations, including the rela- 2018-4. tively low number of patients. We also had only 3 male patients (5%), which preclude a reliable analysis of item Authors’ contributions 7b, judged to be specific to that gender. It is worth men- FVAA, JN, and FACR conceived the article. Data acquisition, analysis and/or interpretation: FVAA, AJ, HALR, JN, FACR. Draft and revision of the work: tioning that hand OA is very predominant in females FVAA, AJ, HALR, JN, FACR. All authors approved the final version of the and most previous similar FIHOA translational studies manuscript. All authors are accountable for all aspects of the work also had a similar low prevalence of male participants [9, particularly regarding integrity of the data and collection of material. 11, 12, 19, 22, 23]. There was a mean 10-year difference Funding between the groups that participated in the pre-test and This study received partial support of this work from the Conselho Nacional test-retest phases. The selection was at random and we de Desenvolvimento Científico e Tecnológico (CNPQ), Brasil – Grant 308429/ believe this difference was irrelevant since the under- 2018–4. standing of the phrasing was similar between both Availability of data and materials groups. All data generated or analysed during this study are included in this The evaluation of hand functionality through gender- published article. specific questions can have its added value quite ques- Declarations tionable in societies where a high and growing number of individuals of both genders have been performing Ethics approval and consent to participate similar tasks in their daily lives. It is assumed that there This work was fully compliant with Ethical Standards and receive approval from an Ethics Review Board accredited by the Conselho Nacional de Ética is a greater influence of a socio-cultural aspect than a em Pesquisa – Brasil (Ethics Approval: CAAE:07360819930015045; May 20, functional difference between the two specific questions 2019). for each gender. Further studies are needed to investi- Consent for publication gate whether this gender-specific issue can be eliminated Not applicable or replaced. Neither did we assess the number and loca- tion of the affected joints, nor the presence of Heberden Competing interests and Bouchard nodes and deformities caused by OA, The author and co-authors declare that there are no conflicts of interest to disclose concerning the publication of this article. which may influence dexterity and functional capacity of the fingers. Indeed, the number of nodes in the hands Author details and involvement of the base of the thumb and wrists Department of Internal Medicine - Faculdade de Medicina, Universidade Federal do Ceará, Fortaleza, CE, Brazil. Department of Global Health and may be associated with a higher level of pain and func- Population, Harvard T. H. Chan School of Public Health, Boston, MA, USA. tional limitation [19, 24–26]. Six patients didn’t Department of Community Health, Federal University of Ceará, Fortaleza, CE, complete the 1st FIHOA assessment, leaving some blank Brazil. Division of Rheumatology – Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil. Instituto de Biomedicina – items in the questionnaire and were excluded from the Laboratório de Investigação em Osteoartropatias, Rua Cel. Nunes de Melo, analysis. The answers were similar and they justified that 1315 - 1°. Andar, Rodolfo Teófilo, Fortaleza, CE 60430-270, Brazil. they hadn’t performed that task in many years or had Received: 26 January 2021 Accepted: 20 May 2021 never done it (06 patients didn’t know how to sew) and one patient also didn’t know how to answer question 4 and justified that this item didn’t specify the weight of References the bottle that he would try to lift. 1. Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010; 26(3):355–69. https://doi.org/10.1016/j.cger.2010.03.001. 2. Bijsterbosch J, Watt I, Meulenbelt I, Rosendaal FR, Huizinga TWJ, Kloppenburg M. 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