Cross-cultural adaptation and validation of the Italian version of the Hip disability and Osteoarthritis Outcome Score (HOOS)

Cross-cultural adaptation and validation of the Italian version of the Hip disability and... Objective: To create a translated version of the HOOS to fit the Italian population and to test its psychometric properties and validity in hip osteoarthritis (OA) patients undergoing total hip arthroplasty (THA). Design: The HOOS Italian version was developed according to published international guidelines that include preparation, forward translation and reconciliation, backward translation, review and harmonization, and proof reading. The Italian HOOS was administered to 145 patients (mean age 65.7 ± 11.6 years, 34–89, 58.6% women) undergoing THA. The following psychometric properties were evaluated: internal consistency (Cronbach’salpha); test-retest reliability (Pearson’s r and intra-class correlation coefficient, ICC); convergent validity (Spearman’srho between HOOS and SF-36); responsiveness (comparison of pre/post-THA scores, Wilcoxon signed rank test). Interpretability (floor and ceiling effects, skewness and kurtosis indexes) and acceptability (time to compiling, missing answers, and autonomy in compilation) were also evaluated. Results: Translation and transcultural adaptation were conducted in accordance with the international recommendation. The translation was deemed understandable and appropriate as to the transcultural adaptation. None of the patients reported to have met any difficulties in reading and understanding the HOOS items. Internal consistency and test-retest reliability were good for each HOOS subscale (Cronbach’salpha ≥0.7, Pearson’s r and ICC > 0.80). Convergent validity showed the highest correlations (Spearman’s rho > 0.5) between HOOS and SF-36 subscales relating to similar dimensions. As to responsiveness, all HOOS subscales scores improved significantly after THA (p < 0.01). Interpretability was acceptable despite ceiling effect in post-THA assessment. Acceptability was good: HOOS resulted easy and quick to fill out (12 min on average). Conclusions: The HOOS was successfully cross-culturally adapted into Italian. The Italian HOOS showed good psychometric properties therefore it can be useful to assess outcomes in OA patients after THA. This study provided a basis for its use within the Italian Arthroplasty Registry and for future clinical trials. Keywords: HOOS, Hip osteoarthritis, Total hip arthroplasty, Cross-cultural validation, Registry * Correspondence: marina.torre@iss.it National Centre for Clinical Excellence, Safety and Quality of Care, Istituto Superiore di Sanità, Viale Regina Elena 299, Rome, Italy Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 2 of 9 Background Preparation Hip osteoarthritis (OA) is one of the major causes of The RIAP project leader and principal investigator of chronic disability and has a significantimpactonpatients’ the study (MT) asked the HOOS developer Professor health-related quality of life (HRQoL). HRQoL assessment Ewa Roos to check if any other Italian translation was tools are based on patients’ opinion [patient-reported out- ongoing. Then, she received permission to use and comes measures (PROMs)] and focus on the evaluation of translate the HOOS into Italian. physical, psychological and social functions, and well-being. The Hip disability and Osteoarthritis Outcome Score Forward translation and reconciliation (HOOS) was developed in 2003 [1–3]toask forthe pa- Two Italian mother tongue translators with a different tients’ view about their hip limited functions. The HOOS is professional background, a bioengineer (MT) and an a validated self-administered questionnaire developed in orthopaedic surgeon (ER), independently translated the English as an extension of the Western Ontario and questionnaire into Italian. Then, a consensus meeting was McMaster Universities Osteoarthritis Index (WOMAC) [1, organized so that the two translators could meet and agree 2] therefore a comparison between the two is feasible. The upon a single shared version. HOOS, that was translated and validated in several lan- guages [4–10], showed to be effective in measuring Backward translation patient-relevant outcomes in OA patients even after THA, An English mother tongue translator having no specific and more responsive than the WOMAC in younger and background in the health field, and blinded to the ori- physically active patients [1, 2]. ginal HOOS English version, back-translated the ques- The main aims of the study were developing the Italian tionnaire into English. translation of the HOOS and evaluating its psychometric properties (internal consistency, test-retest reliability, con- Review and harmonization vergent validity, and responsiveness), along with its inter- A multidisciplinary committee that included the two trans- pretability and acceptability. In addition, based on other lators (MT and ER) and another orthopaedic surgeon (GZ) arthroplasty registries experience [11], the present analysis with a documented expertise in questionnaire validation, was also performed in the perspective of introducing reviewed and made the back-translation consistently. To HOOS in the setting of the Italian Arthroplasty Registry discuss the final version, the existing Italian version of project (RIAP, www.iss.it/riap)[12]. WOMAC [18] was also taken into account, since the ori- ginal HOOS was partly derived from it. Finally, the com- Method mittee agreed on a questionnaire that was checked against The study was started as a line of research of the RIAP, understandability and transcultural adaptation. which is funded by the Ministry of Health and coordi- nated by the Italian National Institute of Health [Istituto Proof reading Superiore di Sanità (ISS)]. It was approved by the ISS The last agreed questionnaire was administered to a sub- Ethical Committee and organized in two steps. Firstly, group of seven OA patients undergoing THA for cogni- the English HOOS was translated into Italian and tive debriefing, to test alternative wording and check adapted to the Italian setting. Secondly, its psychometric understandability, interpretation, and cultural relevance properties were assessed in a prospective study by test- of the translation. After the last review, the final Italian ing internal consistency, test-retest reliability, convergent HOOS was released. validity, and responsiveness. Interpretability and accept- ability were also evaluated. COSMIN guidelines and Patient enrollment and questionnaires administration checklist were used to verify the whole translation and A total of 145 patients (mean age = 65.7 ± 11.6, range validation process [13–15]. The data collected during 34–89, 58.6% women) admitted in the orthopaedic units the study were treated in compliance with the Italian le- of five Italian hospitals collaborating with RIAP were en- gislation on personal data protection and sent to ISS in rolled in an observational prospective multicentre study. an anonymous form. The inclusion criteria were: age ≥ 18 years, diagnosis of hip OA, and indication for primary THA. Patients not Development of the Italian version of the HOOS: translation legally competent or not able, due to their health status, and cross-cultural adaptation or having a diagnosis of fracture, or indication for revi- The translation process was performed according to the sion surgery were excluded. The enrolled patients were published international recommendations [16, 17]and ar- duly informed and their written consent to participate ranged in six phases: preparation, forward translation, rec- was collected. They were asked to fill out the Italian onciliation, backward translation, review and harmonization, HOOS before surgery, to assess internal consistency. proof reading. Among them, 34 agreed to fill out the HOOS one more Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 3 of 9 time to evaluate test-retest reliability (5–21 days from SF-36 SF-36 [19] is a widespread, validated psychomet- the first administration). To assess convergent validity, a ric generic questionnaire on HRQoL, also available in subset of 37 patients was requested to fill out the SF-36. Italian [20]. It groups 36 items into eight multi-item Out of 108 patients eligible for follow-up, 24 dropped scales: Physical Functioning (PF), Role-Physical (RP), out (22.22%). Finally, 84 patients were assessed at Bodily Pain (BP), General Health (GH), Vitality (VT), follow-up (5–25 months). To evaluate HOOS respon- Social Functioning (SF), Role-Emotional (RE) and Men- siveness and interpretability, only the ones that had filled tal Health (MH). For each subscale, a score can range out the questionnaires within 11 months after surgery from zero (worst possible health status) to 100 (best pos- (79) were included (Fig. 1). The preoperative HOOS sible health status), following the standard SF-36 scoring compilation was performed during pre-hospitalization algorithms. The SF-36 subscales scores were computed (82.1%) or at admission (17.9%), while postoperative using the algorithm for the Statistical Package for the compilation was performed in the outpatient department Social Sciences (SPSS), available from the Mario Negri setting during follow-up assessment. Institute for Pharmacological Research website [21]. Questionnaires Assessment of psychometric properties Internal consistency HOOS HOOS was firstly developed in Sweden in 2003 Internal consistency is defined as “the degree of the from the Knee injury and Osteoarthritis Outcome Score interrelatedness among the items” [13]. It was evaluated (KOOS). It is a self-administered questionnaire and using Cronbach’s alpha coefficient. A coefficient ≥ 0.70 consists of 40 items divided into five subscales assessing was considered satisfactory [4]. five distinct patient-relevant dimensions: Pain (P), Symp- toms (S), Activity of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) and Hip related Quality Test-retest reliability of Life (QoL). The patients can express their opinion Test-retest reliability is defined as “the extent to which through standardized response options based on the scores for patients who have not changed are the same for five-point Likert scale (none, mild, moderate, severe, ex- repeated measurement […]over time” [13]. It was treme); each answer is scored ranging from zero (no prob- assessed using Pearson’s correlation coefficient and lems) to four (extreme problems). A normalized score intra-class correlation coefficient (ICC, two-way random (100 indicating no symptoms and zero indicating extreme effect model, assuming a single measurement and absolute symptoms) is calculated for each subscale (100-subscale agreement with 95% confidence interval). ICC values average/4*100) and can be plotted as an outcome profile [3]. ≥0.80 expressed good reliability [4, 5]. Fig. 1 Flow-chart of the validation process, and involved patients for each stage Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 4 of 9 Convergent validity 6, 25] and kurtosis and asymmetry indices (≤ |1.0|) were Convergent validity is part of the construct validity. Con- defined [26, 27]. struct validity is defined as “the degree to which the scores of an HR-PRO instrument are consistent with hypotheses Acceptability based on the assumption that the HR-PRO instrument Acceptability of the Italian HOOS was investigated in validly measures the construct to be measured” [13]and is pre-THA by measuring the average time needed to fill the combination of convergent validity between conceptu- out the HOOS, the proportion of missing answers, and ally similar items/domains of the questionnaires com- the self-confidence of patients in compilation. A compil- pared, and divergent (or discriminant) validity between ation time < 15 min was considered satisfactory [3, 10]. dissimilar items or domains [22]. The convergent validity Referring to the proportion of missing answers and pa- was tested by using Spearman’s rank correlation coeffi- tients needing support in compilation, a < 5% value was cient between the results of each HOOS and SF-36 sub- assumed to be acceptable [10]. scales. Spearman’s correlation coefficients (rho) > 0.50, 0.35–0.50, and < 0.35 were considered strong, moderate Missing data and weak correlations, respectively [6, 7, 9]. As reported Missing data were treated as follows. HOOS: the HOOS by Scalone et al. [23], to be considered relevant for con- Scoring instructions were applied [28]; SF-36: the algo- vergence, the correlation coefficients between equivalent rithm developed by the Mario Negri Institute for domains are required to be higher than 0.2 and statisti- Pharmacological Research [21] according to the SF-36 cally significant. The a priori hypothesis was that strong instructions was applied. correlations would be observed between the subscales measuring similar domains (i.e. SF-36 BP vs HOOS Pain, Statistics SF-36 PF vs HOOS ADL). SPSS version 23.0 was used for statistical analyses. P values of < 0.05 were considered significant. Responsiveness Responsiveness is defined as “the ability of an HR-PRO Results instrument to detect change over time in the construct Development of the Italian version of the HOOS: translation to be measured” [13]. This property measures the cap- and cross-cultural adaptation ability of the questionnaire to capture real changes, i.e. it Some difficulties arose only when translating items P4 measures the sensitivity to change if real changes occur. “Walking on a flat surface” and A12 “Lying in bed (turning It was tested by comparing the pre- and post-THA over, maintaining hip position)”. No patients reported scores of every HOOS subscale using the Wilcoxon having met problems in reading and understanding the signed rank test for paired data, considering a level of HOOS items. significance < 0.01 [6, 7]. Moreover, the Standardized Re- sponse Mean (SRM), i.e. the mean change between base- Assessment of psychometric properties line and follow-up divided by the SD of this change, and Internal consistency the Effect Size (ES), i.e. the mean score change between Table 1 shows the internal consistency for the patients baseline and follow-up divided by the SD of the baseline enrolled in the study (145). Cronbach’s alpha ranged values were calculated [4], considering them large when from 0.70 to 0.96. ≥0.80 [2, 24]. Test-retest reliability Assessment of interpretability and acceptability The measurement of test-retest reliability performed on Interpretability a subset of 34 patients is showed in Table 2. For all the According to the COSMIN study [13], interpretability is not considered a measurement property, but an import- Table 1 Internal consistency of the five HOOS subscales, n =145 ant characteristic of a measurement instrument. It is HOOS subscales Cronbach’s alpha coefficient (95% CI) defined as “the degree to which one can assign qualita- Symptoms 0.70 (0.62–0.77) tive meaning - that is, clinical or commonly understood Pain 0.89 (0.86–0.92) connotations – to an instrument’s quantitative scores or ADL 0.96 (0.95–0.97) change in scores”. It was assessed by calculating floor and ceiling effects and kurtosis and asymmetry indices Sport/Rec 0.89 (0.85–0.91) for each HOOS subscale pre- and post-THA. A priori values QoL 0.80 (0.74–0.85) for floor and ceiling effects (> 15% of participants respond- ADL Activity of Daily Living, Sport/Rec Sports and Recreational activities, QoL ing with the lowest/highest possible score, respectively) [4– Quality of Life Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 5 of 9 Table 2 Test-retest reliability for the five HOOS subscales, n =34 Assessment of interpretability and acceptability Interpretability HOOS subscales Pearson’s coefficient ICC (95% CI) Data from 79 patients were assessed to measure interpret- Symptoms 0.91 0.91 (0.83–0.96) ability. Floor effect was found in preoperative assessment Pain 0.91 0.91 (0.82–0.95) in subscales Sport/Rec (26.92%) and QoL (22.78%). Ceiling ADL 0.89 0.87 (0.71–0.94) effect was found in postoperative assessment in all the Sport/Rec 0.84 0.81 (0.58–0.91) subscales, particularly in QoL (40.51%). The values of QoL 0.83 0.81 (0.62–0.90) skewness and kurtosis were lower or slightly above unity, ADL Activity of Daily Living, Sport/Rec Sports and Recreational activities, QoL except for kurtosis of the Pain subscale in postoperative Quality of Life assessment (2.85) (Table 5). Italian HOOS subscales, Pearson’s correlation coefficient Acceptability ranged from 0.83–0.91 and ICC from 0.81 to 0.91. Acceptability was tested on the preoperative administra- tion of the HOOS (145 patients). On average, the time to fill out the questionnaire was 12 min. The proportion Convergent validity of missing data was 1.16% (Symptoms 0.28%, Pain Thirty-seven patients were asked to fill out the SF-36 1.17%, ADL 1.50%, and Sport/Rec 1.90%). No missing to evaluate convergent validity. Spearman’scorrelation data were registered for QoL. The item A13 “Getting in/ coefficient values > 0.50 were found for subscales re- out of bath” (derived from WOMAC) recorded the high- ferred to similar measures (i.e. BP vs each HOOS est number of missing answers (4.94%). Some elderly pa- subscale rho> 0.60; SF vs ADL, rho = 0.55; PF and MH tients (3%) requested to be assisted by a relative or, more vs Sport/Rec, rho = 0.57). Lower values (rho ≤0.22) rarely, an operator to fill out the questionnaire. were found between subscales referred to different aspects of the construct (i.e. RE vs each HOOS sub- Discussion scale) (Table 3). In the present study, the Italian version of HOOS was de- veloped and the psychometric properties were assessed. Translation into Italian and cross-cultural adaptation of Responsiveness the English version posed some difficulties that were re- Responsiveness was tested by comparison of the pre- solved anyway. In the end, no patient reported issues in operative and postoperative scores of 79 patients. All reading and understanding the HOOS items. The psycho- HOOS subscales scores improved significantly after metric properties showed that the Italian version of THA (p < 0.001) as determined using Wilcoxon signed HOOS is a valid and reliable tool to assess outcomes in rank test (Fig. 2). ES ranged from 2.72 to 3.71 and SRM OA patients undergoing THA. from 1.84 to 2.38 (Table 4). The results of the assessment of the internal consistency were good for all subscales and were comparable to those observed in other language versions of the HOOS [4–7, 9] Table 3 Convergent validity: Spearman’s correlation coefficients suggesting good homogeneity. Cronbach’s alpha ADL sub- between each subscale of the Italian HOOS and SF-36, n =37 scale scored the highest value (0.96), according to the HOOS subscales French (0.94) [4], Dutch (THA) (0.95) [5], Korean (0.96) Symptoms Pain ADL Sport/Rec QoL [6] and original HOOS (0.96) [1] validation studies. As re- SF-36 subscales ported by other authors [5, 6], values of Cronbach’salpha PF 0.42 0.58 0.65 0.57 0.46 greater than 0.90 mean that some of the 17 items of the ADL subscale could be removed because they may be re- RP 0.28 0.37 0.46 0.55 0.32 dundant. The Symptoms subscale presented the lowest BP 0.61 0.75 0.73 0.66 0.69 value (0.70) of the Cronbach’s alpha. Although acceptable GH 0.21 0.34 0.38 0.29 0.18 and higher than that found for the French version (0.66) VT 0.36 0.48 0.47 0.47 0.42 [4], it improved to 0.77 when item S1 (Do you feel grind- SF 0.49 0.61 0.55 0.55 0.45 ing, hear clicking or any other type of noise from your RE 0.23 0.15 0.17 0.24 0.13 hip?) was excluded from the analysis. This result is closer to the value measured in another study (0.75) [6]. In fact, MH 0.45 0.48 0.52 0.57 0.42 this item presented a higher response variability compared Bold figures indicate significant correlation (p < 0.05) PF Physical Functioning, RP Role-Physical, BP Bodily Pain, GH General Health, to the others of the same subscale. In addition, its lower VT Vitality, SF Social Functioning, RE Role-Emotional, MH Mental Health, ADL consistency with the other items of the Symptom’ssub- Activity of Daily Living, Sport/Rec Sports and Recreational activities, QoL Quality of Life scale might be due to the fact that two different types of Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 6 of 9 Fig. 2 HOOS profiles before (Pre) and after (Post) THA (n = 79). The Wilcoxon signed rank test was used to compare the Pre and Post data of each subscale of the Italian HOOS. This scale is 0–100, worst to best. *: p <0.001 perception are simultaneously investigated (a hip joint in- versions [2, 5, 6], all the HOOS subscales showed the ternal noise compared to a physical difficulty). highest correlations with the SF-36 subscale BP, confirm- Similarly to the results found in French (0.83–0.89) ing the important role of this component in defining per- [4], Dutch (THA) (0.75–0.89) [5] and original HOOS ceived health status in OA patients undergoing THA. The (0.78–0.91) [1] validation studies, test-retest reliability correlation between PF and ADL measured for the Italian ICC ranged from 0.81 to 0.91, showing that the Italian HOOS (0.65) is strong, as already observed in the Japanese HOOS appears to be stable over time. (0.61) [7], Dutch (0.72) [5], Korean (0.80) [6] and in the The a priori hypothesis for convergent validity was original HOOS (0.66) [2] validation studies. The HOOS confirmed. Likewise it was observed in other language subscales showed mostly moderate and weak correlations with SF-36 VT and MH and RP, GH, RE, respectively. Table 4 Responsiveness of the Italian HOOS subscales. Mean Responsiveness to clinical change is an important and standard deviation (SD) before (Pre) and after (Post) THA; property of outcome measures. In the present study, all Wilcoxon signed rank test statistical significance (p-value); Effect the subscales showed good responsiveness and all sub- Size (ES); Standardized Response Mean (SRM), n =79 scales scores improved postoperatively, compared to the HOOS subscales Mean SD p-value ES SRM preoperative ones (p < 0.001). These results are consist- Symptoms ent with what was clinically observed for THA since its Pre 37.44 15.56 < 0.001 2.93 2.09 introduction in the 1960s. In his study [29], Harris de- fined THA the most successful surgery for OA patients, Post 83.84 15.83 and Learmonth described it as “the operation of the cen- Pain tury” [30]. Initially restricted to either elderly and infirm Pre 37.17 15.54 < 0.001 3.32 2.38 people or individuals with limitations affecting locomo- Post 88.78 14.48 tion, today THA is mainly intended for individuals who ADL deem unacceptable a compromise in quality of life [30]. Pre 35.58 17.16 < 0.001 2.90 2.19 The ES (2.72–3.71) and SRM (1.84–2.38) of the Italian HOOS were comparable to the values measured in the Post 85.27 15.78 French (ES: 1.97–3.24; SRM: 1.54–2.08) [4] and Chinese Sport/Rec (ES: 2.53–3.33; SRM: 2.16–3.12) [10] validation studies. Pre 20.51 19.94 < 0.001 2.72 1.84 High values of ES and SRM were showed by all the lan- Post 74.76 23.23 guage validation studies of HOOS that enrolled patients QoL undergoing THA [2, 4, 7, 10], a procedure that usually Pre 18.99 15.84 < 0.001 3.71 2.03 determines a great improvement in clinical outcomes. Floor effect was observed in preoperative administration Post 77.77 25.41 for subscales Sport/Rec (26.92%) and QoL (22.78%). Ceil- ADL Activity of Daily Living, Sport/Rec Sports and Recreational activities, QoL Quality of Life ing effect was found in post-THA assessment for the Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 7 of 9 Table 5 Interpretability of Italian HOOS. Skewness and kurtosis values, and floor and ceiling effects, before (Pre) and after (Post) THA, n =79 Skewness Kurtosis Floor effect (%) Ceiling effect (%) HOOS subscale Pre Post Pre Post Pre Post Pre Post Symptoms 0.44 −0.81 0.75 −0.22 0.00 0.00 0.00 27.85 Pain 0.70 −1.75 0.86 2.85 0.00 0.00 0.00 29.11 ADL 1.03 −1.17 1.82 0.56 0.00 0.00 0.00 15.19 Sport/Rec 1.18 −0.69 1.65 −0.21 26.92 0.00 0.00 28.21 QoL 0.74 −0.83 0.34 −0.65 22.78 0.00 0.00 40.51 ADL Activity of Daily Living, Sport/Rec Sports and Recreational activities, QoL Quality of Life subscales Symptoms (27.85%), Pain (29.11%), Sport/Rec to collect data from OA patients undergoing THA in (28.21%), and QoL (40.51%). According to the French Italy. Data collection raised some difficulties, therefore study [4], the only observing a floor effect (17.8%), the patients were arranged in several subgroups and differ- markedly lower scores measured in the two subscales not ent outcomes were assessed. Even if collecting data from included in the WOMAC (Sport/Rec and QoL) might be several hospitals might be considered a limitation for the related to the age of patients (French: 67.5 years [50–81], study, it was a valuable opportunity to test the Italian Italian: 65.7 [34–89]). Ceiling effect was observed in other HOOS in a real rather than experimental setting. For ex- studies for Pain (HOOS validation: 19% [2], Japanese: 44% ample, while assessing responsiveness and interpretabil- [7]) and Symptoms (Japanese: 29% [7]) but not for Sport/ ity, it was possible to detect that in one single hospital Rec and QoL subscales. This effect was explored further unit a response bias had been introduced leading to by performing a subgroup analysis based on age, gender higher values for postoperative measurements. When and hospital. While no significant differences were ob- that unit was excluded from the data analysis, both ES served for age and gender, the analysis by hospitals and ceiling effects shifted to values closer to those of highlighted for a single hospital postoperative values in all other studies. This led to the awareness that to optimize the subscales significantly higher than those measured in a HR-PRO instrument’s properties, the burden to re- the other hospitals. After excluding this hospital from the spondents and healthcare personnel in completing and analysis, Pain remained the only subscale showing a ceil- administering questionnaires should be taken into ac- ing effect (15.38%). However, it has to be taken into ac- count [11]. In addition, the questionnaire administration count that, considering the increased effectiveness should be standardized to avoid possible response bias. of THA, high ceiling effect can be expected and that the A further limitation is that only a generic HRQoL ques- criterion of having the best possible score in less than 15% tionnaire was used to test convergent validity. Although of respondents might be too restrictive [31–33]. Asymmetry the results obtained are consistent with what expected, and kurtosis values were generally less than unity showing a the use of a disease-specific questionnaire on hip dys- good enough discriminant capacity of the subscales. function besides the SF-36 might have assessed this psy- The Italian HOOS proved to be acceptable, easily chometric property in a more specific way. understood and could be self-administered in about To the best of our knowledge, this is the first study 12 min. The item that registered the highest number of adapting and validating the HOOS in Italy. Translating it missing answers (4.94%) was A13 “Getting in/out of posed a few difficulties regarding the wording related to bath” (derived from WOMAC), in most of the cases ex- items P4 (Walking on a flat surface) and A12 (Lying in plained by the patients because they didn’t have a bath- bed (turning over, maintaining hip position)). As to P4, it tub in their home. At the time WOMAC was developed, was discussed if “flat” meant “having a continuous hori- most of the houses had bathtubs. Today it is different as zontal surface” or “having a relatively smooth or even sur- many houses are often equipped only with showers. As face”. The latter would have been a counterpart for item Ewa Roos already did while adapting WOMAC to the P10 “Walking on an uneven surface” where “uneven” is Swedish setting [34], and as it is in the Danish, Dutch, used. In fact, the back translator into English used the Norwegian, Polish and Swedish HOOS translations [35], word “even” for P4. In the end, the Italian word “piana” item A13 will be corrected also in the final Italian was selected, which is similarly ambiguous and was also HOOS, substituting it with “Getting in/out of bath/ used in the Italian WOMAC [18]. As to A12, the comma shower”, after the validation study will be completed was discarded and the sentence interpreted in a way that (see Additional file 1). lead to this back translation “turning over while keeping Five orthopaedic units of hospitals from different geo- your hip still”. The question was if in the original version graphical areas were recruited in this multicentre study these two actions were assumed to be disjoined (“turning Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 8 of 9 over in bed” or “maintaining hip position still while lying Towards Evidence) working group that encouraged and supported the development of projects using PROMs. Finally, the authors wish to thank in bed”). All these cross-language and transcultural issues Professor Ewa Roos for her advice on the transcultural adaptation process. were discussed and it was decided that the first part of the item (“lying in bed”) was already indicating a still position, Funding The study was funded by the Italian Ministry of Health, Directorate General therefore the sentence without the comma was kept. of Medical Devices and Pharmaceutical Services. No funders were involved in Issues concerning items P4, A12 and A13 were shared the study design, in the collection, analysis, and interpretation of data, in the with one of the original HOOS authors, Ewa Roos, and writing of the manuscript, and in the decision to submit the manuscript for publication. other researchers that are currently working on a project aiming to develop a short version of the HOOS. On 17 Availability of data and materials February 2017, they emailed the principal investigator of The dataset analyzed in the current study is available from the corresponding author on reasonable request. this study (MT) asking to be provided with any feedback about the ease or difficulty of translating the items into Authors’ contributions Italian. Since the HOOS is an international instrument, MT: Study conception and design; Translation and transcultural adaptation of the HOOS; Obtaining of funding. IL, FM, MDM: Data analysis and interpretation. they considered ideal to incorporate as much inter- GZ: Translation and transcultural adaptation of the HOOS; Data acquisition. GT: national perspective as possible about the items into the Data acquisition. ER: Study conception and design; Translation and transcultural selection process. In their opinion, in fact, it would be a adaptation of the HOOS; Data acquisition. All the authors drafted, critically revised for important intellectual content and approved the final version of the huge mistake to include in a HOOS short form an item article. MT takes responsibility for the integrity of the work as a whole. that is difficult to translate into other languages (Barbara Gandek and Ewa Roos, personal communication 2017). Ethics approval and consent to participate The study obtained approval from the Ethical Committee of ISS (CE-ISS10/ 288) and from the Scientific Committee of the Italian Arthroplasty Registry Conclusions project (RIAP). All participants gave written, fully-informed consent to participate in the study and for their data to be reported anonymously. The English HOOS was translated into Italian and trans- culturally adapted, in accordance with international guide- Competing interests lines. The Italian HOOS showed to be a reliable tool to The authors declare that they have no competing interests. assess patient-related outcomes and effectiveness of clin- ical interventions in OA patients undergoing THA. Publisher’sNote Springer Nature remains neutral with regard to jurisdictional claims in published Its ability to detect changes over time and its easiness maps and institutional affiliations. suggest it could be a useful tool to be implemented within the RIAP routine data collection. Author details National Centre for Clinical Excellence, Safety and Quality of Care, Istituto Superiore di Sanità, Viale Regina Elena 299, Rome, Italy. Center for Behavioral Additional file Sciences and Mental Health, Istituto Superiore di Sanità, Viale Regina Elena 299, Rome, Italy. Department of Infectious Diseases, Istituto Superiore di Sanità, Viale Regina Elena 299, Rome, Italy. Casa di Cura Santa Maria Additional file 1: Hip disability and Osteoarthritis Outcome Score (HOOS), Maddalena, Via Gorizia 2, Occhiobello, RO, Italy. Department of Italian version, LK 2.0, March 2017. (PDF 303 kb) Orthopaedics and Traumatology, Ospedale S. Giuseppe, Via Olivella Km 1, Albano Laziale, RM, Italy. ArtroGruppo, Casa di Cura San Feliciano, Via Enrico Abbreviations De Ossò 6, Rome, Italy. ADL: Activity of Daily Living; BP: Bodily Pain; ES: Effect Size; GH: General Health; HOOS: Hip disability and Osteoarthritis Outcome Score; HR-PRO: Health-Related Received: 13 April 2017 Accepted: 16 May 2018 Patient-Reported Outcomes; HRQoL: Health-related quality of life; ICC: Intra-class correlation coefficient; ISS: Istituto Superiore di Sanità; KOOS: Knee injury and Osteoarthritis Outcome Score; MH: Mental Health; OA: Osteoarthritis; P: Pain; References PF: Physical Functioning; PROMs: Patient-reported outcomes measures; 1. Klässbo M, Larsson E, Mannevik E. Hip disability and osteoarthritis outcome QoL: Quality of Life; RE: Role-Emotional; RIAP: Italian Arthroplasty Registry score. An extension of the Western Ontario and McMaster Universities project; RP: Role-Physical; S: Symptoms; SD: Standard Deviation; SF: Social Osteoarthritis Index. Scand J Rheumatol. 2003;32:46–51. Functioning; SF-36: 36-Item Short Form Health Survey; Sport/Rec: Sport and 2. Nilsdotter AK, Lohmander LS, Klässbo M, Roos EM. Hip disability and Recreation Function; SPSS: Statistical Package for the Social Sciences; osteoarthritis outcome score (HOOS) - validity and responsiveness in total SRM: Standardized Response Mean; THA: Total Hip Arthroplasty; VT: Vitality; hip replacement. BMC Musculoskelet Disord. 2003;30:4–10. WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index 3. Questionnaires, user’s guides and scoring files. HOOS User’s Guide 2003. http://www.koos.nu. Updated May 2008. Accessed 24 May 2018. Acknowledgements 4. Ornetti P, Parratte S, Gossec L, Tavernier C, Argenson JN, Roos EM, et al. The authors acknowledge Marcella Marletta (Director of the Medical Devices Cross-cultural adaptation and validation of the French version of the Hip and Pharmaceutical Services General Directorate of the Italian Ministry of disability and Osteoarthritis Outcome Score (HOOS) in hip osteoarthritis Health) for her continuing supporting the Italian Arthroplasty Registry patients. Osteoarthr Cartil. 2010;18:522–9. project, Luigi Zagra and Adriano Rizzo of Galeazzi Orthopaedic Institute 5. de Groot IB, Reijman M, Terwee CB, Bierma-Zeinstra SMA, Favejee M, Roos IRCCS (Milan) and Renato Laforgia of Mater Dei Hospital (Bari) for patient EM, et al. Validation of the Dutch version of the Hip disability and enrollment, questionnaire administration and data collection, Mascia Osteoarthritis Outcome Score. Osteoarthr Cartil. 2007;15:104–9. Masciocchi (ISS) for data assembly, Stefania Ceccarelli (ISS) for editorial 6. Lee YK, Chung CY, Koo KH, Lee KM, Lee DJ, Lee SC, et al. Transcultural assistance, Mark Kanieff for backward translation, and Letizia Sampaolo (ISS) adaptation and testing of psychometric properties of the Korean version of for linguistic revision. The authors also acknowledge Raffaella Bucciardini, the Hip Disability and Osteoarthritis Outcome Score (HOOS). Osteoarthr responsible at ISS for the PROmote (Patient-Reported Outcomes MOving Cartil. 2011;19:853–7. Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 9 of 9 7. Satoh M, Masuhara K, Goldhahn S, Kawaguchi T. Cross-cultural adaptation 29. Harris WH, Sledge CB. Total hip and total knee replacement (1). N Engl J and validation reliability, validity of the Japanese version of the Hip Med. 1990;323:725–3. disability and Osteoarthritis Outcome Score (HOOS) in patients with hip 30. Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip osteoarthritis. Osteoarthr Cartil. 2013;21:570–3. replacement. Lancet. 2007;370:1508–19. 8. Blasimann A, Dauphinee SW, Staal JB. Translation, cross-cultural adaptation, 31. Paulsen A, Pedersen AB, Overgaard S, Roos EM. Feasibility of 4 patient- and psychometric properties of the German version of the hip disability and reported outcome measures in a registry setting. A cross-sectional osteoarthritis outcome score. J Orthop Sports Phys Ther. 2014;44:989–97. study of 6,000 patients from the Danish Hip Arthroplasty Registry. Acta Orthop. 2012;83:321–7. 9. Trathitiphan W, Paholpak P, Sirichativapee W, Wisanuyotin T, 32. Paradowski PT, Witoński D, Kęska R, Roos EM. Cross-cultural translation and Laupattarakasem P, Sukhonthamarn K, et al. Cross-cultural adaptation and measurement properties of the polish version of the Knee injury and validation of the reliability of the Thai version of the Hip disability and Osteoarthritis Outcome Score (KOOS) following anterior cruciate ligament Osteoarthritis Outcome Score (HOOS). Rheumatol Int. 2016;36:1455–8. reconstruction. Health Qual Life Outcomes. 2013;11:107. 10. Wei X, Wang Z, Yang C, Wu B, Liu X, Yi H, et al. Development of a simplified 33. Paulsen A, Odgaard A, Overgaard S. Translation, cross-cultural Chinese version of the Hip Disability and Osteoarthritis Outcome Score adaptation and validation of the Danish version of the Oxford hip (HOOS): cross-cultural adaptation and psychometric evaluation. Osteoarthr score: assessed against generic and disease-specific questionnaires. Cartil. 2012;20:1563–7. Bone Joint Res. 2012;1:225–33. 11. Rolfson O, Chenok KE, Bohm E, Lübbeke A, Denissen G, Dunn J, et al. 34. Roos EM, Klässbo M, Lohmander LS. WOMAC osteoarthritis index: reliability, Patient-reported outcome measures in arthroplasty registries. Acta Orthop. validity, and responsiveness in patients with arthroscopically assessed 2016;87:3–8. osteoarthritis. Scand J Rheumatol. 1999;28:210–5. 12. Torre M, Romanini E, Zanoli G, Carrani E, Luzi I, Leone L, et al. Monitoring 35. Questionnaires, user’s guides and scoring files. HOOS. http://www.koos.nu. outcome of joint arthroplasty in Italy: implementation of the National Accessed 24 May 2018. Registry. Joints. 2017;5:70–8. 13. Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, et al. International consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes: results of the COSMIN study. J Clin Epidemiol. 2010;63:737–45. 14. Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, et al. The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol. 2010;10:22. 15. Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010;19:539–49. 16. Beaton DE,Bombardier C,Guillemin F,Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine. 2000;25:3186–91. 17. Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, et al. Principles of good practice for the translation and cultural adaptation process for Patient-Reported Outcomes (PRO) measures: report of the ISPOR task force for translation and cultural adaptation. Value Health. 2005;8:94–104. 18. Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, et al. Reliability and validity of the western Ontario and McMaster universities (WOMAC) osteoarthritis index in Italian patients with osteoarthritis of the knee group. Osteoarthr Cartil. 2003;11:551–60. 19. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF- 36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83. 20. Apolone G, Mosconi P. The Italian SF-36 health survey: translation, validation and norming. J Clin Epidemiol. 1998;51:1025–36. 21. Qualità della vita e stato di salute. Strumenti di valutazione. Il questionario SF-36. Programma SPSS. http://crc.marionegri.it/qdv/downloads/ SF36%20SPSS.SPS. Accessed 24 May 2018. 22. Campbell DT. Convergent and discriminant validation by the multitrait- multimethod matrix. Psychol Bull. 1959;56:81–105. 23. Scalone L, Tomasetto C, Matteucci MC, Selleri P, Broccoli S, Pacelli B, Cavrini G. Assessing quality of life in children and adolescents: development and validation of the Italian version of the EQ-5D-Y. IJPH. 2011;8:331–41. 24. Angst F, Verra ML, Lehmann S, Aeschlimann A. Responsiveness of five condition-specific and generic outcome assessment instruments for chronic pain. BMC Med Res Methodol. 2008;8:26. 25. McHorney CA, Tarlov AR. Individual-patient monitoring in clinical practice: are available health status surveys adequate? Qual Life Res. 1995;4:293–307. 26. Barbaranelli C. Tecniche multivariate per la ricerca psicologica e sociale. Milano: Led Edizioni; 2003. 27. George D, Mallery P. SPSS for windows step by step: a simple guide and reference 17.0 update. 10th ed. Boston: Pearson; 2010. 28. Questionnaires, user’s guides and scoring files. Hip disability and Osteoarthritis Outcome Score (HOOS) Scoring instructions. http://www.koos.nu.June 2013. Accessed 24 May 2018. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Health and Quality of Life Outcomes Springer Journals

Cross-cultural adaptation and validation of the Italian version of the Hip disability and Osteoarthritis Outcome Score (HOOS)

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Medicine & Public Health; Quality of Life Research; Quality of Life Research
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Abstract

Objective: To create a translated version of the HOOS to fit the Italian population and to test its psychometric properties and validity in hip osteoarthritis (OA) patients undergoing total hip arthroplasty (THA). Design: The HOOS Italian version was developed according to published international guidelines that include preparation, forward translation and reconciliation, backward translation, review and harmonization, and proof reading. The Italian HOOS was administered to 145 patients (mean age 65.7 ± 11.6 years, 34–89, 58.6% women) undergoing THA. The following psychometric properties were evaluated: internal consistency (Cronbach’salpha); test-retest reliability (Pearson’s r and intra-class correlation coefficient, ICC); convergent validity (Spearman’srho between HOOS and SF-36); responsiveness (comparison of pre/post-THA scores, Wilcoxon signed rank test). Interpretability (floor and ceiling effects, skewness and kurtosis indexes) and acceptability (time to compiling, missing answers, and autonomy in compilation) were also evaluated. Results: Translation and transcultural adaptation were conducted in accordance with the international recommendation. The translation was deemed understandable and appropriate as to the transcultural adaptation. None of the patients reported to have met any difficulties in reading and understanding the HOOS items. Internal consistency and test-retest reliability were good for each HOOS subscale (Cronbach’salpha ≥0.7, Pearson’s r and ICC > 0.80). Convergent validity showed the highest correlations (Spearman’s rho > 0.5) between HOOS and SF-36 subscales relating to similar dimensions. As to responsiveness, all HOOS subscales scores improved significantly after THA (p < 0.01). Interpretability was acceptable despite ceiling effect in post-THA assessment. Acceptability was good: HOOS resulted easy and quick to fill out (12 min on average). Conclusions: The HOOS was successfully cross-culturally adapted into Italian. The Italian HOOS showed good psychometric properties therefore it can be useful to assess outcomes in OA patients after THA. This study provided a basis for its use within the Italian Arthroplasty Registry and for future clinical trials. Keywords: HOOS, Hip osteoarthritis, Total hip arthroplasty, Cross-cultural validation, Registry * Correspondence: marina.torre@iss.it National Centre for Clinical Excellence, Safety and Quality of Care, Istituto Superiore di Sanità, Viale Regina Elena 299, Rome, Italy Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 2 of 9 Background Preparation Hip osteoarthritis (OA) is one of the major causes of The RIAP project leader and principal investigator of chronic disability and has a significantimpactonpatients’ the study (MT) asked the HOOS developer Professor health-related quality of life (HRQoL). HRQoL assessment Ewa Roos to check if any other Italian translation was tools are based on patients’ opinion [patient-reported out- ongoing. Then, she received permission to use and comes measures (PROMs)] and focus on the evaluation of translate the HOOS into Italian. physical, psychological and social functions, and well-being. The Hip disability and Osteoarthritis Outcome Score Forward translation and reconciliation (HOOS) was developed in 2003 [1–3]toask forthe pa- Two Italian mother tongue translators with a different tients’ view about their hip limited functions. The HOOS is professional background, a bioengineer (MT) and an a validated self-administered questionnaire developed in orthopaedic surgeon (ER), independently translated the English as an extension of the Western Ontario and questionnaire into Italian. Then, a consensus meeting was McMaster Universities Osteoarthritis Index (WOMAC) [1, organized so that the two translators could meet and agree 2] therefore a comparison between the two is feasible. The upon a single shared version. HOOS, that was translated and validated in several lan- guages [4–10], showed to be effective in measuring Backward translation patient-relevant outcomes in OA patients even after THA, An English mother tongue translator having no specific and more responsive than the WOMAC in younger and background in the health field, and blinded to the ori- physically active patients [1, 2]. ginal HOOS English version, back-translated the ques- The main aims of the study were developing the Italian tionnaire into English. translation of the HOOS and evaluating its psychometric properties (internal consistency, test-retest reliability, con- Review and harmonization vergent validity, and responsiveness), along with its inter- A multidisciplinary committee that included the two trans- pretability and acceptability. In addition, based on other lators (MT and ER) and another orthopaedic surgeon (GZ) arthroplasty registries experience [11], the present analysis with a documented expertise in questionnaire validation, was also performed in the perspective of introducing reviewed and made the back-translation consistently. To HOOS in the setting of the Italian Arthroplasty Registry discuss the final version, the existing Italian version of project (RIAP, www.iss.it/riap)[12]. WOMAC [18] was also taken into account, since the ori- ginal HOOS was partly derived from it. Finally, the com- Method mittee agreed on a questionnaire that was checked against The study was started as a line of research of the RIAP, understandability and transcultural adaptation. which is funded by the Ministry of Health and coordi- nated by the Italian National Institute of Health [Istituto Proof reading Superiore di Sanità (ISS)]. It was approved by the ISS The last agreed questionnaire was administered to a sub- Ethical Committee and organized in two steps. Firstly, group of seven OA patients undergoing THA for cogni- the English HOOS was translated into Italian and tive debriefing, to test alternative wording and check adapted to the Italian setting. Secondly, its psychometric understandability, interpretation, and cultural relevance properties were assessed in a prospective study by test- of the translation. After the last review, the final Italian ing internal consistency, test-retest reliability, convergent HOOS was released. validity, and responsiveness. Interpretability and accept- ability were also evaluated. COSMIN guidelines and Patient enrollment and questionnaires administration checklist were used to verify the whole translation and A total of 145 patients (mean age = 65.7 ± 11.6, range validation process [13–15]. The data collected during 34–89, 58.6% women) admitted in the orthopaedic units the study were treated in compliance with the Italian le- of five Italian hospitals collaborating with RIAP were en- gislation on personal data protection and sent to ISS in rolled in an observational prospective multicentre study. an anonymous form. The inclusion criteria were: age ≥ 18 years, diagnosis of hip OA, and indication for primary THA. Patients not Development of the Italian version of the HOOS: translation legally competent or not able, due to their health status, and cross-cultural adaptation or having a diagnosis of fracture, or indication for revi- The translation process was performed according to the sion surgery were excluded. The enrolled patients were published international recommendations [16, 17]and ar- duly informed and their written consent to participate ranged in six phases: preparation, forward translation, rec- was collected. They were asked to fill out the Italian onciliation, backward translation, review and harmonization, HOOS before surgery, to assess internal consistency. proof reading. Among them, 34 agreed to fill out the HOOS one more Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 3 of 9 time to evaluate test-retest reliability (5–21 days from SF-36 SF-36 [19] is a widespread, validated psychomet- the first administration). To assess convergent validity, a ric generic questionnaire on HRQoL, also available in subset of 37 patients was requested to fill out the SF-36. Italian [20]. It groups 36 items into eight multi-item Out of 108 patients eligible for follow-up, 24 dropped scales: Physical Functioning (PF), Role-Physical (RP), out (22.22%). Finally, 84 patients were assessed at Bodily Pain (BP), General Health (GH), Vitality (VT), follow-up (5–25 months). To evaluate HOOS respon- Social Functioning (SF), Role-Emotional (RE) and Men- siveness and interpretability, only the ones that had filled tal Health (MH). For each subscale, a score can range out the questionnaires within 11 months after surgery from zero (worst possible health status) to 100 (best pos- (79) were included (Fig. 1). The preoperative HOOS sible health status), following the standard SF-36 scoring compilation was performed during pre-hospitalization algorithms. The SF-36 subscales scores were computed (82.1%) or at admission (17.9%), while postoperative using the algorithm for the Statistical Package for the compilation was performed in the outpatient department Social Sciences (SPSS), available from the Mario Negri setting during follow-up assessment. Institute for Pharmacological Research website [21]. Questionnaires Assessment of psychometric properties Internal consistency HOOS HOOS was firstly developed in Sweden in 2003 Internal consistency is defined as “the degree of the from the Knee injury and Osteoarthritis Outcome Score interrelatedness among the items” [13]. It was evaluated (KOOS). It is a self-administered questionnaire and using Cronbach’s alpha coefficient. A coefficient ≥ 0.70 consists of 40 items divided into five subscales assessing was considered satisfactory [4]. five distinct patient-relevant dimensions: Pain (P), Symp- toms (S), Activity of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) and Hip related Quality Test-retest reliability of Life (QoL). The patients can express their opinion Test-retest reliability is defined as “the extent to which through standardized response options based on the scores for patients who have not changed are the same for five-point Likert scale (none, mild, moderate, severe, ex- repeated measurement […]over time” [13]. It was treme); each answer is scored ranging from zero (no prob- assessed using Pearson’s correlation coefficient and lems) to four (extreme problems). A normalized score intra-class correlation coefficient (ICC, two-way random (100 indicating no symptoms and zero indicating extreme effect model, assuming a single measurement and absolute symptoms) is calculated for each subscale (100-subscale agreement with 95% confidence interval). ICC values average/4*100) and can be plotted as an outcome profile [3]. ≥0.80 expressed good reliability [4, 5]. Fig. 1 Flow-chart of the validation process, and involved patients for each stage Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 4 of 9 Convergent validity 6, 25] and kurtosis and asymmetry indices (≤ |1.0|) were Convergent validity is part of the construct validity. Con- defined [26, 27]. struct validity is defined as “the degree to which the scores of an HR-PRO instrument are consistent with hypotheses Acceptability based on the assumption that the HR-PRO instrument Acceptability of the Italian HOOS was investigated in validly measures the construct to be measured” [13]and is pre-THA by measuring the average time needed to fill the combination of convergent validity between conceptu- out the HOOS, the proportion of missing answers, and ally similar items/domains of the questionnaires com- the self-confidence of patients in compilation. A compil- pared, and divergent (or discriminant) validity between ation time < 15 min was considered satisfactory [3, 10]. dissimilar items or domains [22]. The convergent validity Referring to the proportion of missing answers and pa- was tested by using Spearman’s rank correlation coeffi- tients needing support in compilation, a < 5% value was cient between the results of each HOOS and SF-36 sub- assumed to be acceptable [10]. scales. Spearman’s correlation coefficients (rho) > 0.50, 0.35–0.50, and < 0.35 were considered strong, moderate Missing data and weak correlations, respectively [6, 7, 9]. As reported Missing data were treated as follows. HOOS: the HOOS by Scalone et al. [23], to be considered relevant for con- Scoring instructions were applied [28]; SF-36: the algo- vergence, the correlation coefficients between equivalent rithm developed by the Mario Negri Institute for domains are required to be higher than 0.2 and statisti- Pharmacological Research [21] according to the SF-36 cally significant. The a priori hypothesis was that strong instructions was applied. correlations would be observed between the subscales measuring similar domains (i.e. SF-36 BP vs HOOS Pain, Statistics SF-36 PF vs HOOS ADL). SPSS version 23.0 was used for statistical analyses. P values of < 0.05 were considered significant. Responsiveness Responsiveness is defined as “the ability of an HR-PRO Results instrument to detect change over time in the construct Development of the Italian version of the HOOS: translation to be measured” [13]. This property measures the cap- and cross-cultural adaptation ability of the questionnaire to capture real changes, i.e. it Some difficulties arose only when translating items P4 measures the sensitivity to change if real changes occur. “Walking on a flat surface” and A12 “Lying in bed (turning It was tested by comparing the pre- and post-THA over, maintaining hip position)”. No patients reported scores of every HOOS subscale using the Wilcoxon having met problems in reading and understanding the signed rank test for paired data, considering a level of HOOS items. significance < 0.01 [6, 7]. Moreover, the Standardized Re- sponse Mean (SRM), i.e. the mean change between base- Assessment of psychometric properties line and follow-up divided by the SD of this change, and Internal consistency the Effect Size (ES), i.e. the mean score change between Table 1 shows the internal consistency for the patients baseline and follow-up divided by the SD of the baseline enrolled in the study (145). Cronbach’s alpha ranged values were calculated [4], considering them large when from 0.70 to 0.96. ≥0.80 [2, 24]. Test-retest reliability Assessment of interpretability and acceptability The measurement of test-retest reliability performed on Interpretability a subset of 34 patients is showed in Table 2. For all the According to the COSMIN study [13], interpretability is not considered a measurement property, but an import- Table 1 Internal consistency of the five HOOS subscales, n =145 ant characteristic of a measurement instrument. It is HOOS subscales Cronbach’s alpha coefficient (95% CI) defined as “the degree to which one can assign qualita- Symptoms 0.70 (0.62–0.77) tive meaning - that is, clinical or commonly understood Pain 0.89 (0.86–0.92) connotations – to an instrument’s quantitative scores or ADL 0.96 (0.95–0.97) change in scores”. It was assessed by calculating floor and ceiling effects and kurtosis and asymmetry indices Sport/Rec 0.89 (0.85–0.91) for each HOOS subscale pre- and post-THA. A priori values QoL 0.80 (0.74–0.85) for floor and ceiling effects (> 15% of participants respond- ADL Activity of Daily Living, Sport/Rec Sports and Recreational activities, QoL ing with the lowest/highest possible score, respectively) [4– Quality of Life Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 5 of 9 Table 2 Test-retest reliability for the five HOOS subscales, n =34 Assessment of interpretability and acceptability Interpretability HOOS subscales Pearson’s coefficient ICC (95% CI) Data from 79 patients were assessed to measure interpret- Symptoms 0.91 0.91 (0.83–0.96) ability. Floor effect was found in preoperative assessment Pain 0.91 0.91 (0.82–0.95) in subscales Sport/Rec (26.92%) and QoL (22.78%). Ceiling ADL 0.89 0.87 (0.71–0.94) effect was found in postoperative assessment in all the Sport/Rec 0.84 0.81 (0.58–0.91) subscales, particularly in QoL (40.51%). The values of QoL 0.83 0.81 (0.62–0.90) skewness and kurtosis were lower or slightly above unity, ADL Activity of Daily Living, Sport/Rec Sports and Recreational activities, QoL except for kurtosis of the Pain subscale in postoperative Quality of Life assessment (2.85) (Table 5). Italian HOOS subscales, Pearson’s correlation coefficient Acceptability ranged from 0.83–0.91 and ICC from 0.81 to 0.91. Acceptability was tested on the preoperative administra- tion of the HOOS (145 patients). On average, the time to fill out the questionnaire was 12 min. The proportion Convergent validity of missing data was 1.16% (Symptoms 0.28%, Pain Thirty-seven patients were asked to fill out the SF-36 1.17%, ADL 1.50%, and Sport/Rec 1.90%). No missing to evaluate convergent validity. Spearman’scorrelation data were registered for QoL. The item A13 “Getting in/ coefficient values > 0.50 were found for subscales re- out of bath” (derived from WOMAC) recorded the high- ferred to similar measures (i.e. BP vs each HOOS est number of missing answers (4.94%). Some elderly pa- subscale rho> 0.60; SF vs ADL, rho = 0.55; PF and MH tients (3%) requested to be assisted by a relative or, more vs Sport/Rec, rho = 0.57). Lower values (rho ≤0.22) rarely, an operator to fill out the questionnaire. were found between subscales referred to different aspects of the construct (i.e. RE vs each HOOS sub- Discussion scale) (Table 3). In the present study, the Italian version of HOOS was de- veloped and the psychometric properties were assessed. Translation into Italian and cross-cultural adaptation of Responsiveness the English version posed some difficulties that were re- Responsiveness was tested by comparison of the pre- solved anyway. In the end, no patient reported issues in operative and postoperative scores of 79 patients. All reading and understanding the HOOS items. The psycho- HOOS subscales scores improved significantly after metric properties showed that the Italian version of THA (p < 0.001) as determined using Wilcoxon signed HOOS is a valid and reliable tool to assess outcomes in rank test (Fig. 2). ES ranged from 2.72 to 3.71 and SRM OA patients undergoing THA. from 1.84 to 2.38 (Table 4). The results of the assessment of the internal consistency were good for all subscales and were comparable to those observed in other language versions of the HOOS [4–7, 9] Table 3 Convergent validity: Spearman’s correlation coefficients suggesting good homogeneity. Cronbach’s alpha ADL sub- between each subscale of the Italian HOOS and SF-36, n =37 scale scored the highest value (0.96), according to the HOOS subscales French (0.94) [4], Dutch (THA) (0.95) [5], Korean (0.96) Symptoms Pain ADL Sport/Rec QoL [6] and original HOOS (0.96) [1] validation studies. As re- SF-36 subscales ported by other authors [5, 6], values of Cronbach’salpha PF 0.42 0.58 0.65 0.57 0.46 greater than 0.90 mean that some of the 17 items of the ADL subscale could be removed because they may be re- RP 0.28 0.37 0.46 0.55 0.32 dundant. The Symptoms subscale presented the lowest BP 0.61 0.75 0.73 0.66 0.69 value (0.70) of the Cronbach’s alpha. Although acceptable GH 0.21 0.34 0.38 0.29 0.18 and higher than that found for the French version (0.66) VT 0.36 0.48 0.47 0.47 0.42 [4], it improved to 0.77 when item S1 (Do you feel grind- SF 0.49 0.61 0.55 0.55 0.45 ing, hear clicking or any other type of noise from your RE 0.23 0.15 0.17 0.24 0.13 hip?) was excluded from the analysis. This result is closer to the value measured in another study (0.75) [6]. In fact, MH 0.45 0.48 0.52 0.57 0.42 this item presented a higher response variability compared Bold figures indicate significant correlation (p < 0.05) PF Physical Functioning, RP Role-Physical, BP Bodily Pain, GH General Health, to the others of the same subscale. In addition, its lower VT Vitality, SF Social Functioning, RE Role-Emotional, MH Mental Health, ADL consistency with the other items of the Symptom’ssub- Activity of Daily Living, Sport/Rec Sports and Recreational activities, QoL Quality of Life scale might be due to the fact that two different types of Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 6 of 9 Fig. 2 HOOS profiles before (Pre) and after (Post) THA (n = 79). The Wilcoxon signed rank test was used to compare the Pre and Post data of each subscale of the Italian HOOS. This scale is 0–100, worst to best. *: p <0.001 perception are simultaneously investigated (a hip joint in- versions [2, 5, 6], all the HOOS subscales showed the ternal noise compared to a physical difficulty). highest correlations with the SF-36 subscale BP, confirm- Similarly to the results found in French (0.83–0.89) ing the important role of this component in defining per- [4], Dutch (THA) (0.75–0.89) [5] and original HOOS ceived health status in OA patients undergoing THA. The (0.78–0.91) [1] validation studies, test-retest reliability correlation between PF and ADL measured for the Italian ICC ranged from 0.81 to 0.91, showing that the Italian HOOS (0.65) is strong, as already observed in the Japanese HOOS appears to be stable over time. (0.61) [7], Dutch (0.72) [5], Korean (0.80) [6] and in the The a priori hypothesis for convergent validity was original HOOS (0.66) [2] validation studies. The HOOS confirmed. Likewise it was observed in other language subscales showed mostly moderate and weak correlations with SF-36 VT and MH and RP, GH, RE, respectively. Table 4 Responsiveness of the Italian HOOS subscales. Mean Responsiveness to clinical change is an important and standard deviation (SD) before (Pre) and after (Post) THA; property of outcome measures. In the present study, all Wilcoxon signed rank test statistical significance (p-value); Effect the subscales showed good responsiveness and all sub- Size (ES); Standardized Response Mean (SRM), n =79 scales scores improved postoperatively, compared to the HOOS subscales Mean SD p-value ES SRM preoperative ones (p < 0.001). These results are consist- Symptoms ent with what was clinically observed for THA since its Pre 37.44 15.56 < 0.001 2.93 2.09 introduction in the 1960s. In his study [29], Harris de- fined THA the most successful surgery for OA patients, Post 83.84 15.83 and Learmonth described it as “the operation of the cen- Pain tury” [30]. Initially restricted to either elderly and infirm Pre 37.17 15.54 < 0.001 3.32 2.38 people or individuals with limitations affecting locomo- Post 88.78 14.48 tion, today THA is mainly intended for individuals who ADL deem unacceptable a compromise in quality of life [30]. Pre 35.58 17.16 < 0.001 2.90 2.19 The ES (2.72–3.71) and SRM (1.84–2.38) of the Italian HOOS were comparable to the values measured in the Post 85.27 15.78 French (ES: 1.97–3.24; SRM: 1.54–2.08) [4] and Chinese Sport/Rec (ES: 2.53–3.33; SRM: 2.16–3.12) [10] validation studies. Pre 20.51 19.94 < 0.001 2.72 1.84 High values of ES and SRM were showed by all the lan- Post 74.76 23.23 guage validation studies of HOOS that enrolled patients QoL undergoing THA [2, 4, 7, 10], a procedure that usually Pre 18.99 15.84 < 0.001 3.71 2.03 determines a great improvement in clinical outcomes. Floor effect was observed in preoperative administration Post 77.77 25.41 for subscales Sport/Rec (26.92%) and QoL (22.78%). Ceil- ADL Activity of Daily Living, Sport/Rec Sports and Recreational activities, QoL Quality of Life ing effect was found in post-THA assessment for the Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 7 of 9 Table 5 Interpretability of Italian HOOS. Skewness and kurtosis values, and floor and ceiling effects, before (Pre) and after (Post) THA, n =79 Skewness Kurtosis Floor effect (%) Ceiling effect (%) HOOS subscale Pre Post Pre Post Pre Post Pre Post Symptoms 0.44 −0.81 0.75 −0.22 0.00 0.00 0.00 27.85 Pain 0.70 −1.75 0.86 2.85 0.00 0.00 0.00 29.11 ADL 1.03 −1.17 1.82 0.56 0.00 0.00 0.00 15.19 Sport/Rec 1.18 −0.69 1.65 −0.21 26.92 0.00 0.00 28.21 QoL 0.74 −0.83 0.34 −0.65 22.78 0.00 0.00 40.51 ADL Activity of Daily Living, Sport/Rec Sports and Recreational activities, QoL Quality of Life subscales Symptoms (27.85%), Pain (29.11%), Sport/Rec to collect data from OA patients undergoing THA in (28.21%), and QoL (40.51%). According to the French Italy. Data collection raised some difficulties, therefore study [4], the only observing a floor effect (17.8%), the patients were arranged in several subgroups and differ- markedly lower scores measured in the two subscales not ent outcomes were assessed. Even if collecting data from included in the WOMAC (Sport/Rec and QoL) might be several hospitals might be considered a limitation for the related to the age of patients (French: 67.5 years [50–81], study, it was a valuable opportunity to test the Italian Italian: 65.7 [34–89]). Ceiling effect was observed in other HOOS in a real rather than experimental setting. For ex- studies for Pain (HOOS validation: 19% [2], Japanese: 44% ample, while assessing responsiveness and interpretabil- [7]) and Symptoms (Japanese: 29% [7]) but not for Sport/ ity, it was possible to detect that in one single hospital Rec and QoL subscales. This effect was explored further unit a response bias had been introduced leading to by performing a subgroup analysis based on age, gender higher values for postoperative measurements. When and hospital. While no significant differences were ob- that unit was excluded from the data analysis, both ES served for age and gender, the analysis by hospitals and ceiling effects shifted to values closer to those of highlighted for a single hospital postoperative values in all other studies. This led to the awareness that to optimize the subscales significantly higher than those measured in a HR-PRO instrument’s properties, the burden to re- the other hospitals. After excluding this hospital from the spondents and healthcare personnel in completing and analysis, Pain remained the only subscale showing a ceil- administering questionnaires should be taken into ac- ing effect (15.38%). However, it has to be taken into ac- count [11]. In addition, the questionnaire administration count that, considering the increased effectiveness should be standardized to avoid possible response bias. of THA, high ceiling effect can be expected and that the A further limitation is that only a generic HRQoL ques- criterion of having the best possible score in less than 15% tionnaire was used to test convergent validity. Although of respondents might be too restrictive [31–33]. Asymmetry the results obtained are consistent with what expected, and kurtosis values were generally less than unity showing a the use of a disease-specific questionnaire on hip dys- good enough discriminant capacity of the subscales. function besides the SF-36 might have assessed this psy- The Italian HOOS proved to be acceptable, easily chometric property in a more specific way. understood and could be self-administered in about To the best of our knowledge, this is the first study 12 min. The item that registered the highest number of adapting and validating the HOOS in Italy. Translating it missing answers (4.94%) was A13 “Getting in/out of posed a few difficulties regarding the wording related to bath” (derived from WOMAC), in most of the cases ex- items P4 (Walking on a flat surface) and A12 (Lying in plained by the patients because they didn’t have a bath- bed (turning over, maintaining hip position)). As to P4, it tub in their home. At the time WOMAC was developed, was discussed if “flat” meant “having a continuous hori- most of the houses had bathtubs. Today it is different as zontal surface” or “having a relatively smooth or even sur- many houses are often equipped only with showers. As face”. The latter would have been a counterpart for item Ewa Roos already did while adapting WOMAC to the P10 “Walking on an uneven surface” where “uneven” is Swedish setting [34], and as it is in the Danish, Dutch, used. In fact, the back translator into English used the Norwegian, Polish and Swedish HOOS translations [35], word “even” for P4. In the end, the Italian word “piana” item A13 will be corrected also in the final Italian was selected, which is similarly ambiguous and was also HOOS, substituting it with “Getting in/out of bath/ used in the Italian WOMAC [18]. As to A12, the comma shower”, after the validation study will be completed was discarded and the sentence interpreted in a way that (see Additional file 1). lead to this back translation “turning over while keeping Five orthopaedic units of hospitals from different geo- your hip still”. The question was if in the original version graphical areas were recruited in this multicentre study these two actions were assumed to be disjoined (“turning Torre et al. Health and Quality of Life Outcomes (2018) 16:115 Page 8 of 9 over in bed” or “maintaining hip position still while lying Towards Evidence) working group that encouraged and supported the development of projects using PROMs. Finally, the authors wish to thank in bed”). All these cross-language and transcultural issues Professor Ewa Roos for her advice on the transcultural adaptation process. were discussed and it was decided that the first part of the item (“lying in bed”) was already indicating a still position, Funding The study was funded by the Italian Ministry of Health, Directorate General therefore the sentence without the comma was kept. of Medical Devices and Pharmaceutical Services. No funders were involved in Issues concerning items P4, A12 and A13 were shared the study design, in the collection, analysis, and interpretation of data, in the with one of the original HOOS authors, Ewa Roos, and writing of the manuscript, and in the decision to submit the manuscript for publication. other researchers that are currently working on a project aiming to develop a short version of the HOOS. On 17 Availability of data and materials February 2017, they emailed the principal investigator of The dataset analyzed in the current study is available from the corresponding author on reasonable request. this study (MT) asking to be provided with any feedback about the ease or difficulty of translating the items into Authors’ contributions Italian. Since the HOOS is an international instrument, MT: Study conception and design; Translation and transcultural adaptation of the HOOS; Obtaining of funding. IL, FM, MDM: Data analysis and interpretation. they considered ideal to incorporate as much inter- GZ: Translation and transcultural adaptation of the HOOS; Data acquisition. GT: national perspective as possible about the items into the Data acquisition. ER: Study conception and design; Translation and transcultural selection process. In their opinion, in fact, it would be a adaptation of the HOOS; Data acquisition. All the authors drafted, critically revised for important intellectual content and approved the final version of the huge mistake to include in a HOOS short form an item article. MT takes responsibility for the integrity of the work as a whole. that is difficult to translate into other languages (Barbara Gandek and Ewa Roos, personal communication 2017). Ethics approval and consent to participate The study obtained approval from the Ethical Committee of ISS (CE-ISS10/ 288) and from the Scientific Committee of the Italian Arthroplasty Registry Conclusions project (RIAP). All participants gave written, fully-informed consent to participate in the study and for their data to be reported anonymously. The English HOOS was translated into Italian and trans- culturally adapted, in accordance with international guide- Competing interests lines. The Italian HOOS showed to be a reliable tool to The authors declare that they have no competing interests. assess patient-related outcomes and effectiveness of clin- ical interventions in OA patients undergoing THA. Publisher’sNote Springer Nature remains neutral with regard to jurisdictional claims in published Its ability to detect changes over time and its easiness maps and institutional affiliations. suggest it could be a useful tool to be implemented within the RIAP routine data collection. Author details National Centre for Clinical Excellence, Safety and Quality of Care, Istituto Superiore di Sanità, Viale Regina Elena 299, Rome, Italy. Center for Behavioral Additional file Sciences and Mental Health, Istituto Superiore di Sanità, Viale Regina Elena 299, Rome, Italy. Department of Infectious Diseases, Istituto Superiore di Sanità, Viale Regina Elena 299, Rome, Italy. Casa di Cura Santa Maria Additional file 1: Hip disability and Osteoarthritis Outcome Score (HOOS), Maddalena, Via Gorizia 2, Occhiobello, RO, Italy. Department of Italian version, LK 2.0, March 2017. (PDF 303 kb) Orthopaedics and Traumatology, Ospedale S. Giuseppe, Via Olivella Km 1, Albano Laziale, RM, Italy. ArtroGruppo, Casa di Cura San Feliciano, Via Enrico Abbreviations De Ossò 6, Rome, Italy. ADL: Activity of Daily Living; BP: Bodily Pain; ES: Effect Size; GH: General Health; HOOS: Hip disability and Osteoarthritis Outcome Score; HR-PRO: Health-Related Received: 13 April 2017 Accepted: 16 May 2018 Patient-Reported Outcomes; HRQoL: Health-related quality of life; ICC: Intra-class correlation coefficient; ISS: Istituto Superiore di Sanità; KOOS: Knee injury and Osteoarthritis Outcome Score; MH: Mental Health; OA: Osteoarthritis; P: Pain; References PF: Physical Functioning; PROMs: Patient-reported outcomes measures; 1. Klässbo M, Larsson E, Mannevik E. Hip disability and osteoarthritis outcome QoL: Quality of Life; RE: Role-Emotional; RIAP: Italian Arthroplasty Registry score. An extension of the Western Ontario and McMaster Universities project; RP: Role-Physical; S: Symptoms; SD: Standard Deviation; SF: Social Osteoarthritis Index. Scand J Rheumatol. 2003;32:46–51. Functioning; SF-36: 36-Item Short Form Health Survey; Sport/Rec: Sport and 2. 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Health and Quality of Life OutcomesSpringer Journals

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