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Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty
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Original article
Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty Shahnaz Klouche a,∗ , Johannes M. Giesinger b , El-Hadi Sariali a a b
Hôpitaux universitaires La Pitié Salpêtrière-Charles Foix, AP–HP, 75013, Paris, France Department of psychiatry and psychotherapy, Innsbruck Medical University, 6020 Innsbruck, Austria
a r t i c l e
i n f o
Article history: Received 23 November 2017 Accepted 3 April 2018 Keywords: Forgotten Joint Score Total Hip Arthroplasty Translation Cross-cultural adaption French version
a b s t r a c t Introduction: The ability to “forget” a joint implant in everyday life is considered to be the ultimate objective in arthroplasty. Recently, a scoring system, the Forgotten Joint Score (FJS-12), was published based on a self-administered questionnaire comprising 12 questions assessing how far patients had been able to forget their hip or knee prosthesis. The main objective of the present study was to translate, adapt and assess a French-language version of the FJS-12 in total hip arthroplasty (THA) patients. Patients and methods: The questionnaire was translated by 2 orthopedic surgeons and a medical physician, all bilingual, then back-translated into English by two native English-speaking translators unacquainted with the original. A concertation meeting adopted a beta-version of this Score de Hanche Oubliée (SHO-12), which was then tested on 15 randomly selected THA patients and adapted according to their comments. The final version was validated following the international COSMIN methodology. Data collection was prospective, included all patients operated on by a single surgeon using a single technique. Reference questionnaires comprised Oxford Hip Score (OHS-12) and modified Harris Hip Score (HHS). The 3 assessments were conducted with a minimum 1 year’s follow-up. The SHO-12 was administered twice, with a 1-week interval. Statistical tests assessed construct validity (Pearson correlation test), internal coherence (Cronbach alpha), reliability (intraclass correlation coefficient) and feasibility (percentage missing values, administration time and ceiling and floor effects). Results: Translation/back-translation encountered no particular linguistic problems. Fifty-eight patients (63 THAs) responded to all questionnaires: 22 female, 36 male; mean age, 62.7 ± 15.2 years. Mean followup was 1.6 ± 0.4 years. SHO-12 correlated strongly with OHS-12 and HHS. Internal coherence was good (alpha = 0.96) and reproducibility excellent. No floor or ceiling effects were found. Conclusion: SHO-12, the French-language version of the FJS-12 in THA, is a valid, reproducible selfadministered questionnaire, comparable to the English-language version. Level of evidence: I, Testing of previously developed diagnostic criteria on consecutive patients – Diagnostic study. © 2018 Published by Elsevier Masson SAS.
1. Introduction According to the French Hospital Admissions Information Technical Agency (Agence Technique de l’Information sur l’Hospitalisation [ATIH]), nearly 250,000 primary joint prostheses were implanted in France in 2014, more than half of which were hip prostheses (http://www.scansante.fr/). Several studies, with varying lengths of follow-up, demonstrated the benefits of these procedures in terms of pain, motion and function.
∗ Corresponding author. E-mail addresses: klouche [email protected], [email protected] (S. Klouche).
These clinical results are now well-established, and patients have further expectations, as shown by the study by Mancuso et al. [1]. In this panel of 405 patients, improved walking ability was the main concern expressed preoperatively (99%), followed by daily life activities outside the home (98%) and daytime (95%) and nighttime pain relief (84%), but also return to sports activity (95%), psychological well-being (93%) and improved sexual activity (65%). Impact on sex life has been little studied by surgeons [2,3] and is not well assessed on present functional scoring systems. When they validated a Dutch-language version of the Oxford Hip Score, Goesens et al. [4] added an extra question: “Do you have problems with your sex life because of your hip?”; more than 50% of patients responded to this item.
https://doi.org/10.1016/j.otsr.2018.04.010 1877-0568/© 2018 Published by Elsevier Masson SAS.
Please cite this article in press as: Klouche S, et al. Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty. Orthop Traumatol Surg Res (2017), https://doi.org/10.1016/j.otsr.2018.04.010
G Model OTSR-2023; No. of Pages 5
ARTICLE IN PRESS S. Klouche et al. / Orthopaedics & Traumatology: Surgery & Research xxx (2017) xxx–xxx
2
Being able to “forget” a joint prosthesis in everyday life can be taken to be the ultimate objective of arthroplasty. Recently, a team reported the Forgotten Joint Score (FJS-12), based on a selfadministered questionnaire, comprising 12 questions assessing the extent to which the patient could forget his or her hip or knee prosthesis during various everyday activities [5]; however, it does not assess sexual problems. The FJS has been translated and validated in several languages, for the knee and for the hip [6–10], and for different populations [11]. A French-language version was validated in Belgian knee implant bearers [12]. The main objective of the present study was to translate, adapt and validate a French-language version of the FJS in French patients with total hip arthroplasty (THA). The secondary objective was to assess the interest of an extra question on the ability to forget the prosthesis during sexual activity. The study hypothesis was that this French version is valid, reproducible and comparable to the English-language version.
by mail. One week after reception of the completed questionnaires, the SHO-12 was sent a second time, to assess reproducibility.
2.3. Forgotten Hip Score
2. Material and methods
The original FJS-12 included the main daily life activities expected after joint replacement, as identified on analysis of the literature, expert opinion and patients’ opinions [12]. The questionnaire comprises 12 questions, each on a 5-point Likert scale with boxes to tick ranging from “Never” to “Mostly” and values from 0 to 4. Scores are summed and divided by the number of questions answered, results being invalid in case of more than 4 non-responses. The mean value is then multiplied by 25 then subtracted from 100 points, so that high scores correspond to high levels of forgetting. In the present study, an extra question 12b, “Are you aware of your hip during sexual activity?”, was added at the end of the SHO-12 questionnaire but not included in calculating the final score.
The study had review-board approval. Each participant provided non-refusal.
2.4. Statistical analysis
2.1. Translation and cross-cultural adaptation The procedure followed international guidelines of crosscultural adaptation of self-administered questionnaires [13]. With the agreement of the original authors, the questionnaire was translated by native French-speaking two orthopedic specialists and a medical physician. A preliminary version was drawn up in a concertation meeting and back-translated into English by two native English-speaking translators without medical specialization and unacquainted with the original FJS. A harmonization meeting with all those concerned and a methodologist analyzed the various translations and drew up a beta version. Pretesting was performed in a group of patients who had had primary THA for 2 years, selected randomly from a prospective cohort. The beta version was then adapted in the light of their comments, notably regarding general impression and the precision of the words employed. The pretest group of patients did not take part in the subsequent validation study.
Descriptive analyses were reported as mean, standard deviation and percentage. Construct validity was tested between the SHO-12, modified HHS and OHS-12 on Pearson r, assessed as “strong” (r > 0.5), “moderate” (0.5 < r <0.3) or “weak” correlation (0.3 < r <0.1) [18]. Internal coherence was assessed on Cronbach alpha, with correlation between items considered “excellent” for ˛ ≥ 0.90 [19]. Reliability was assessed on test-retest by Pearson correlation coefficient and intra-class correlation coefficient (ICCC) and classified as “excellent” ( > 0.75), “good” (0.75 < < 0.40) or “poor” ( < 0.40) [20]. Feasibility was assessed by percentage non-response, administration time and floor and ceiling effects corresponding to the number of patients with minimum or maximum scores; according to Terwee et al. [21], beyond 15% there is an inherent problem of content validity in generating items. The significance threshold was set at 0.05. Analyses used XLSTAT software, version 2017.6.
3. Results 2.2. Validity and reproducibility of the final version 3.1. Cross-cultural adaptation The final version of the “Score de Hanche Oubliée” (SHO12) (Fig. 1) was validated following the international COnsensus based Standards for the selection of health status Measurement INstruments (COSMIN) guidelines [14]. A prospective study was conducted from May 2012 to June 2013, including all patients receiving primary THA for osteoarthritis of the hip in our department, operated on by a single surgeon using a single technique. A minimally invasive direct anterior approach was used, with the patient in supine position. Surgery was guided by preoperative ® 3D CT planning (Hip-Plan software) [15], analyzing individual anatomy in 3 dimensions, to determine reconstruction objectives ® and implant sizes (cementless APRIL acetabular component, and ® cementless SPS Evolution stem [Symbios SA, Yverdon, Switzerland]). Patients with history of surgery to the operated hip or refusing to participate were excluded. The reference scales were the modified Harris Hip Score (HHS) [16] and OHS-12 (Oxford Hip Score) [17]. Maximum modified HHS score was 91 points (excellent result); pain was scored on 44 points (no pain) and function on 47 points (excellent). OHS-12 scores vary between 12 (best possible result) and 60 (worst possible results). At a minimum 1 year’s follow-up, patients were contacted by telephone to ascertain oral non-refusal and the 3 questionnaires were sent to them
Translation/back-translation encountered no major linguistic problems. The pretest population comprised 15 patients: 7 male, 8 female; mean age, 60.9 ± 11 years (range, 40–80 years). They had no comments to make.
3.2. Patients in SHO-12 validation and value study The study recruited 93 patients (101 THAs), 58 of whom (63 THAs) completed all the questionnaires: 22 female (24 THAs), 36 male (39 THAs); mean age, 62.7 ± 15.2 years (range, 23.1–89.1 years); mean follow-up, 1.6 ± 0.4 years (range, 1–3.2) years. One patient failed to answer 5 questions and was excluded from analysis. The mean SHO-12 value was 63.1 ± 32.2% (range, 0–100%). Scores were better although not significantly in males (67.5 ± 31.7 vs 54.5 ± 31.7; p = 0.09), and in under-65 year-olds (65.6 ± 34 vs 60.8 ± 30.7, p = 0.56). On average, the activity during which the prosthesis was most forgotten was “. . . when you are taking a bath/shower?” (0.9 ± 1.5) and least forgotten when “. . . when you are standing up from a low-sitting position?” (2 ± 1.6).
Please cite this article in press as: Klouche S, et al. Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty. Orthop Traumatol Surg Res (2017), https://doi.org/10.1016/j.otsr.2018.04.010
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Fig. 1. Score de Hanche Oubliée (SHO-12).
Table 1 Mean scores at a minimum 1 year’s follow-up and construct validity of the SHO-12. SHO-12
(/100)
63.1 ± 32.2(0–100) a
HHS total
(/91)
75.4 ± 18 (30–91) ra = 0.73(Strong)p < 0.00001
HHS pain
(/44)
36.2 ± 11 (10–44) r = 0.66(Strong)p < 0.00001
HHS function
(/47)
39.2 ± 9.1 (16–47) r = 0.65(Strong)p < 0.00001
OHS-12
(/60)
23.4 ± 11.2 (12–47) r = −0.79(Strong)p < 0.00001
Pearson correlation coefficient.
3.3. Construct validity SHO-12 correlated strongly with the reference questionnaires: positively with modified HHS and negatively with OHS-12. (Table 1) (Fig. 2). 3.4. Internal coherence Internal coherence, measuring correlation between the 12 items, was “excellent”, with Cronbach alpha = 0.96. 3.5. Reproducibility Reproducibility was assessed on test-retest. Mean SHO-12 score on first administration was 63.1 ± 32.2 and 65.9 ± 31.9 on second;
the correlation was “strong”, with Pearson r = 0.86; p < 0.00001. Intraclass correlation was “excellent”, with = 0.86 [0.78–0.93]; p < 0.00001 (Fig. 3).
3.6. Feasibility The number of non-responses per item was 0 for questions 2, 3, 5, 6 and 8; 1 (1.6%) for questions 1, 4, 7 and 9, 4 (6.4%) for question 10 (“. . . when you are doing housework or gardening?”), 6 (9.7%) for question 11 (“. . . when you are taking a walk/hiking?”), and 20 (32.3%) for question 12 (“. . . when you are doing your favorite sport?”). Only 3 patients failed to answer all 3 questions 10, 11 and 12. The floor effect (percentage of patients scoring 0%: i.e.
Please cite this article in press as: Klouche S, et al. Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty. Orthop Traumatol Surg Res (2017), https://doi.org/10.1016/j.otsr.2018.04.010
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Fig. 2. Regression curves between SHO-12 and (a) HHS and (b) OHS-12.
Fig. 3. Reproducibility of SHO-12: Bland-Altman plot.
responding “mostly” to all questions) was 1.6%. The ceiling effect (percentage of patients scoring 100%: i.e. responding “never” to all questions) was 12.9%. The floor effect for OHS-12 and HHS was 0%; the ceiling effect was 0% for OHS-12, 34.9% for HHS-function and 49% for HHS-pain. Administration time as reported by patients ranged between 1 and 5–6 minutes. 3.7. Interest of the extra question The question on prosthesis awareness during sexual activity was answered by 45 patients (72.6%), which was more than for the question about sports (67.7%). These patients were significantly younger (p = 0.003). Seven patients spontaneously explained why they did not answer (vow of chastity, widowhood or “too old”): i.e. total response rate of 83.9% (52 patients). 4. Discussion The present study showed that the French-language version of the Forgotten Joint Score in THA is valid, coherent and comparable to the English-language version. No floor or ceiling effects emerged. The present mean follow-up of 1/6 years and mean forgottenhip score of 63.1% were comparable to those in the princeps study by Behrend et al. [5] (59.8% at a mean 2.6 years) and for the Dutch version of Shadid et al. [6] (56.1% at a mean 1.3 years). The present
rate of patients scoring 100% was 12.9%, compared to 8.8% in the study by Hamilton et al. [11] in a British population at 1 year’s follow-up. These scores are lower than those obtained on existing questionnaires. Self-assessment in terms of “awareness” of the prosthesis is very strict, providing more precise assessment of THA outcome. However, the validation study showed that the score correlated strongly with the two reference questionnaires (modified HHS and OHS-12). Overall, the item non-response rate was low. Questions about more physically demanding daily life activities, such as housework, hiking or sport, showed higher non-response rates. These patients seemed not to feel concerned by these questions. Score calculation, as explained by its designers [5], consists in dividing the total number of points by the number of questions answered; questionnaires are excluded from analysis if more than 4 questions are unanswered. This involves a loss of information, whence the interest of using a battery of validated self-administered questionnaires, as recommended for registries [22]. The English-language FJS does not originally include any item on implant awareness during sexual activity. In the present study, we added an extra question on this, to which 84% of patients responded, either directly (73%) or by making comments that were not required. Responses to this question were not included in calculating the SHO, so that the French version would remain strictly comparable to existing versions in other languages. On average, according to the meta-analysis by Issa et al. [3], 76.5% of patients reported pre-THA hip-related sexual problems. It is therefore important to assess satisfactory postoperative recovery of sexual activity, to evaluate surgical results and patient well-being. Nunley et al. [23] published a 13-item questionnaire dedicated to sexual activity, but without a score. We feel it is important for patients to answer the extra question in the SHO preoperatively and at the successive steps of follow-up, even if the results are not included in score calculation. The main limitation of the present study lies in its short followup. Hamilton et al. [24] demonstrated that the FJS-12 was more sensitive to changes occurring between 6 months and 1 year, with significantly greater effect size; the score can be expected not to remain constant over follow-up. The present study did not assess the SHO-12 questionnaire’s sensitivity to change, but the cohort is continuing to fill out the SHO-12 at subsequent follow-up timepoints so as to enable analysis of change in the future.
Please cite this article in press as: Klouche S, et al. Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty. Orthop Traumatol Surg Res (2017), https://doi.org/10.1016/j.otsr.2018.04.010
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5. Conclusion The French-language version of the Forgotten Joint Score in THA is valid, coherent, reproducible and comparable to the Englishlanguage version. It can thus be widely implemented to assess the extent to which THA is “forgotten” by French-speaking patients.
[5]
[6]
[7]
Funding source None. Authors’ contribution S Klouche: study methodology, questionnaire translation, statistical analysis, manuscript writing. JM Giesinger: cross-translation of the questionnaire, manuscript reading. E Sari-Ali: questionnaire translation, manuscript writing, study investigator, data collection. Disclosure of interest Johannes M. Giesinger is the copyright holder of the Forgotten Joint Score (FJS-12). The other authors declare that they have no competing interest.
[8]
[9] [10]
[11]
[12]
[13] [14]
[15]
Acknowledgments The authors thank Ms Marie-Agnès Davet, scientific secretary, for calling patients and sending out and receiving the questionnaires.
[16]
Appendix A. Supplementary data
[18]
Supplementary data associated with this article can be found, in the online version, at https://doi.org.10.1016/j.otsr.2018.04.010. References [1] Mancuso CA, Jout J, Salvati EA, Sculco TP. Fulfillment of patients’ expectations for total hip arthroplasty. J Bone Joint Surg Am 2009;91:2073–8. [2] Laffosse JM, Tricoire JL, Chiron P, Puget J. Sexual function before and after primary total hip arthroplasty. Joint Bone Spine 2008;75: 189–94. [3] Issa K, Pierce TP, Brothers A, Festa A, Scillia AJ, Mont MA. Sexual activity after total hip arthroplasty: a systematic review of the outcomes. J Arthroplasty 2017;32:336–40. [4] Gosens T, Hoefnagels NH, de Vet RC, Dhert WJ, van Langelaan EJ, Bulstra SK, Geesink RG. The “Oxford Heup Score”: the translation and validation of a
[17]
[19] [20] [21]
[22]
[23]
[24]
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questionnaire into Dutch to evaluate the results of total hip arthroplasty. Acta Orthop 2005;76:204–11. Behrend H, Giesinger K, Giesinger JM, Kuster MS. The “forgotten joint” as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty 2012;27:430–6. Shadid MB, Vinken NS, Marting LN, Wolterbeek N. The Dutch version of the Forgotten Joint Score: test-retesting reliability and validation. Acta Orthop Belg 2016;82:112–8. Cao S, Liu N, Han W, et al. Simplified Chinese version of the Forgotten Joint Score (FJS) for patients who underwent joint arthroplasty: cross-cultural adaptation and validation. J Orthop Surg Res 2017;12:6. de Castro Ferreiraa M, Silvab G, Zidanc FF, Franciozia CE, Malheiros Luzod MV, Abdallaa RJ. Forgotten Joint Score–Portuguese translation and cultural adaptation of the instrument of evaluation for hip and knee arthroplasties. Revista Brasileira de Ortopedia 2018;53:221–3. Kinikli GI, Güney Deniz H, Karahan S. Validity and reliability of Turkish version of the Forgotten Joint Score-12. J Exerc Ther Rehabil 2017;4:18–25. Baumann F, Ernstberger T, Loibl M, Zeman F, Nerlich M, Tibesku C. Validation of the German Forgotten Joint Score (G-FJS) according to the COSMIN checklist: does a reduction in joint awareness indicate clinical improvement after arthroplasty of the knee? Arch Orthop Trauma Surg 2016;136:257–64. Hamilton DF, Loth FL, Giesinger JM, et al. Validation of the English language Forgotten Joint Score-12 as an outcome measure for total hip and knee arthroplasty in a British population. Bone Joint J 2017;99–B:218–24. Thienpont E, Opsomer G, Koninckx A, Houssiau F. Joint awareness in different types of knee arthroplasty evaluated with the Forgotten Joint score. J Arthroplasty 2014;29:48–51. 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. Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol 2010;63:737–45. Sariali E, Catonne Y, Pascal-Moussellard H. Three-dimensional planningguided total hip arthroplasty through a minimally invasive direct anterior approach. Clinical outcomes at five years’ follow-up. Int Orthop 2017;41: 699–705. Byrd JW, Jones KS. Prospective analysis of hip arthroscopy with two-year follow-up. Arthroscopy 2000;16:578–87. Delaunay C, Epinette JA, Dawson J, Murray D, Jolles BM. Cross-cultural adaptations of the Oxford-12 HIP score to the French speaking population. Orthop Traumatol Surg Res 2009;95:89–99. Cohen J. Statistical power analysis for the behavioral sciences. 2th ed. NJ, USA: Lawrence Erlbaum Associates, Hillsdale; 1988. Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika 1951;16:297–334. Fleiss JL, Levin B, Paik MC. Statistical methods for rates and proportions. NJ, USA: Wiley, Hoboken; 2003. Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 2007;60:34–42. Franklin PD, Lewallen D, Bozic K, Hallstrom B, Jiranek W, Ayers DC. Implementation of patient-reported outcome measures in U.S. Total joint replacement registries: rationale, status, and plans. J Bone Joint Surg Am 2014;96: 104–9. Nunley RM, Nam D, Bashyal RK, et al. The impact of total joint arthroplasty on sexual function in young, active patients. J Arthroplasty 2015;30: 335–40. Hamilton DF, Giesinger JM, MacDonald DJ, Simpson AH, Howie CR, Giesinger K. Responsiveness and ceiling effects of the Forgotten Joint Score-12 following total hip arthroplasty. Bone Joint Res 2016;5:87–91.
Please cite this article in press as: Klouche S, et al. Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty. Orthop Traumatol Surg Res (2017), https://doi.org/10.1016/j.otsr.2018.04.010
ARTICLE IN PRESS
OTSR-2023; No. of Pages 5
Orthopaedics & Traumatology: Surgery & Research xxx (2017) xxx–xxx
Available online at
ScienceDirect www.sciencedirect.com
Original article
Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty Shahnaz Klouche a,∗ , Johannes M. Giesinger b , El-Hadi Sariali a a b
Hôpitaux universitaires La Pitié Salpêtrière-Charles Foix, AP–HP, 75013, Paris, France Department of psychiatry and psychotherapy, Innsbruck Medical University, 6020 Innsbruck, Austria
a r t i c l e
i n f o
Article history: Received 23 November 2017 Accepted 3 April 2018 Keywords: Forgotten Joint Score Total Hip Arthroplasty Translation Cross-cultural adaption French version
a b s t r a c t Introduction: The ability to “forget” a joint implant in everyday life is considered to be the ultimate objective in arthroplasty. Recently, a scoring system, the Forgotten Joint Score (FJS-12), was published based on a self-administered questionnaire comprising 12 questions assessing how far patients had been able to forget their hip or knee prosthesis. The main objective of the present study was to translate, adapt and assess a French-language version of the FJS-12 in total hip arthroplasty (THA) patients. Patients and methods: The questionnaire was translated by 2 orthopedic surgeons and a medical physician, all bilingual, then back-translated into English by two native English-speaking translators unacquainted with the original. A concertation meeting adopted a beta-version of this Score de Hanche Oubliée (SHO-12), which was then tested on 15 randomly selected THA patients and adapted according to their comments. The final version was validated following the international COSMIN methodology. Data collection was prospective, included all patients operated on by a single surgeon using a single technique. Reference questionnaires comprised Oxford Hip Score (OHS-12) and modified Harris Hip Score (HHS). The 3 assessments were conducted with a minimum 1 year’s follow-up. The SHO-12 was administered twice, with a 1-week interval. Statistical tests assessed construct validity (Pearson correlation test), internal coherence (Cronbach alpha), reliability (intraclass correlation coefficient) and feasibility (percentage missing values, administration time and ceiling and floor effects). Results: Translation/back-translation encountered no particular linguistic problems. Fifty-eight patients (63 THAs) responded to all questionnaires: 22 female, 36 male; mean age, 62.7 ± 15.2 years. Mean followup was 1.6 ± 0.4 years. SHO-12 correlated strongly with OHS-12 and HHS. Internal coherence was good (alpha = 0.96) and reproducibility excellent. No floor or ceiling effects were found. Conclusion: SHO-12, the French-language version of the FJS-12 in THA, is a valid, reproducible selfadministered questionnaire, comparable to the English-language version. Level of evidence: I, Testing of previously developed diagnostic criteria on consecutive patients – Diagnostic study. © 2018 Published by Elsevier Masson SAS.
1. Introduction According to the French Hospital Admissions Information Technical Agency (Agence Technique de l’Information sur l’Hospitalisation [ATIH]), nearly 250,000 primary joint prostheses were implanted in France in 2014, more than half of which were hip prostheses (http://www.scansante.fr/). Several studies, with varying lengths of follow-up, demonstrated the benefits of these procedures in terms of pain, motion and function.
∗ Corresponding author. E-mail addresses: klouche [email protected], [email protected] (S. Klouche).
These clinical results are now well-established, and patients have further expectations, as shown by the study by Mancuso et al. [1]. In this panel of 405 patients, improved walking ability was the main concern expressed preoperatively (99%), followed by daily life activities outside the home (98%) and daytime (95%) and nighttime pain relief (84%), but also return to sports activity (95%), psychological well-being (93%) and improved sexual activity (65%). Impact on sex life has been little studied by surgeons [2,3] and is not well assessed on present functional scoring systems. When they validated a Dutch-language version of the Oxford Hip Score, Goesens et al. [4] added an extra question: “Do you have problems with your sex life because of your hip?”; more than 50% of patients responded to this item.
https://doi.org/10.1016/j.otsr.2018.04.010 1877-0568/© 2018 Published by Elsevier Masson SAS.
Please cite this article in press as: Klouche S, et al. Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty. Orthop Traumatol Surg Res (2017), https://doi.org/10.1016/j.otsr.2018.04.010
G Model OTSR-2023; No. of Pages 5
ARTICLE IN PRESS S. Klouche et al. / Orthopaedics & Traumatology: Surgery & Research xxx (2017) xxx–xxx
2
Being able to “forget” a joint prosthesis in everyday life can be taken to be the ultimate objective of arthroplasty. Recently, a team reported the Forgotten Joint Score (FJS-12), based on a selfadministered questionnaire, comprising 12 questions assessing the extent to which the patient could forget his or her hip or knee prosthesis during various everyday activities [5]; however, it does not assess sexual problems. The FJS has been translated and validated in several languages, for the knee and for the hip [6–10], and for different populations [11]. A French-language version was validated in Belgian knee implant bearers [12]. The main objective of the present study was to translate, adapt and validate a French-language version of the FJS in French patients with total hip arthroplasty (THA). The secondary objective was to assess the interest of an extra question on the ability to forget the prosthesis during sexual activity. The study hypothesis was that this French version is valid, reproducible and comparable to the English-language version.
by mail. One week after reception of the completed questionnaires, the SHO-12 was sent a second time, to assess reproducibility.
2.3. Forgotten Hip Score
2. Material and methods
The original FJS-12 included the main daily life activities expected after joint replacement, as identified on analysis of the literature, expert opinion and patients’ opinions [12]. The questionnaire comprises 12 questions, each on a 5-point Likert scale with boxes to tick ranging from “Never” to “Mostly” and values from 0 to 4. Scores are summed and divided by the number of questions answered, results being invalid in case of more than 4 non-responses. The mean value is then multiplied by 25 then subtracted from 100 points, so that high scores correspond to high levels of forgetting. In the present study, an extra question 12b, “Are you aware of your hip during sexual activity?”, was added at the end of the SHO-12 questionnaire but not included in calculating the final score.
The study had review-board approval. Each participant provided non-refusal.
2.4. Statistical analysis
2.1. Translation and cross-cultural adaptation The procedure followed international guidelines of crosscultural adaptation of self-administered questionnaires [13]. With the agreement of the original authors, the questionnaire was translated by native French-speaking two orthopedic specialists and a medical physician. A preliminary version was drawn up in a concertation meeting and back-translated into English by two native English-speaking translators without medical specialization and unacquainted with the original FJS. A harmonization meeting with all those concerned and a methodologist analyzed the various translations and drew up a beta version. Pretesting was performed in a group of patients who had had primary THA for 2 years, selected randomly from a prospective cohort. The beta version was then adapted in the light of their comments, notably regarding general impression and the precision of the words employed. The pretest group of patients did not take part in the subsequent validation study.
Descriptive analyses were reported as mean, standard deviation and percentage. Construct validity was tested between the SHO-12, modified HHS and OHS-12 on Pearson r, assessed as “strong” (r > 0.5), “moderate” (0.5 < r <0.3) or “weak” correlation (0.3 < r <0.1) [18]. Internal coherence was assessed on Cronbach alpha, with correlation between items considered “excellent” for ˛ ≥ 0.90 [19]. Reliability was assessed on test-retest by Pearson correlation coefficient and intra-class correlation coefficient (ICCC) and classified as “excellent” ( > 0.75), “good” (0.75 < < 0.40) or “poor” ( < 0.40) [20]. Feasibility was assessed by percentage non-response, administration time and floor and ceiling effects corresponding to the number of patients with minimum or maximum scores; according to Terwee et al. [21], beyond 15% there is an inherent problem of content validity in generating items. The significance threshold was set at 0.05. Analyses used XLSTAT software, version 2017.6.
3. Results 2.2. Validity and reproducibility of the final version 3.1. Cross-cultural adaptation The final version of the “Score de Hanche Oubliée” (SHO12) (Fig. 1) was validated following the international COnsensus based Standards for the selection of health status Measurement INstruments (COSMIN) guidelines [14]. A prospective study was conducted from May 2012 to June 2013, including all patients receiving primary THA for osteoarthritis of the hip in our department, operated on by a single surgeon using a single technique. A minimally invasive direct anterior approach was used, with the patient in supine position. Surgery was guided by preoperative ® 3D CT planning (Hip-Plan software) [15], analyzing individual anatomy in 3 dimensions, to determine reconstruction objectives ® and implant sizes (cementless APRIL acetabular component, and ® cementless SPS Evolution stem [Symbios SA, Yverdon, Switzerland]). Patients with history of surgery to the operated hip or refusing to participate were excluded. The reference scales were the modified Harris Hip Score (HHS) [16] and OHS-12 (Oxford Hip Score) [17]. Maximum modified HHS score was 91 points (excellent result); pain was scored on 44 points (no pain) and function on 47 points (excellent). OHS-12 scores vary between 12 (best possible result) and 60 (worst possible results). At a minimum 1 year’s follow-up, patients were contacted by telephone to ascertain oral non-refusal and the 3 questionnaires were sent to them
Translation/back-translation encountered no major linguistic problems. The pretest population comprised 15 patients: 7 male, 8 female; mean age, 60.9 ± 11 years (range, 40–80 years). They had no comments to make.
3.2. Patients in SHO-12 validation and value study The study recruited 93 patients (101 THAs), 58 of whom (63 THAs) completed all the questionnaires: 22 female (24 THAs), 36 male (39 THAs); mean age, 62.7 ± 15.2 years (range, 23.1–89.1 years); mean follow-up, 1.6 ± 0.4 years (range, 1–3.2) years. One patient failed to answer 5 questions and was excluded from analysis. The mean SHO-12 value was 63.1 ± 32.2% (range, 0–100%). Scores were better although not significantly in males (67.5 ± 31.7 vs 54.5 ± 31.7; p = 0.09), and in under-65 year-olds (65.6 ± 34 vs 60.8 ± 30.7, p = 0.56). On average, the activity during which the prosthesis was most forgotten was “. . . when you are taking a bath/shower?” (0.9 ± 1.5) and least forgotten when “. . . when you are standing up from a low-sitting position?” (2 ± 1.6).
Please cite this article in press as: Klouche S, et al. Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty. Orthop Traumatol Surg Res (2017), https://doi.org/10.1016/j.otsr.2018.04.010
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Fig. 1. Score de Hanche Oubliée (SHO-12).
Table 1 Mean scores at a minimum 1 year’s follow-up and construct validity of the SHO-12. SHO-12
(/100)
63.1 ± 32.2(0–100) a
HHS total
(/91)
75.4 ± 18 (30–91) ra = 0.73(Strong)p < 0.00001
HHS pain
(/44)
36.2 ± 11 (10–44) r = 0.66(Strong)p < 0.00001
HHS function
(/47)
39.2 ± 9.1 (16–47) r = 0.65(Strong)p < 0.00001
OHS-12
(/60)
23.4 ± 11.2 (12–47) r = −0.79(Strong)p < 0.00001
Pearson correlation coefficient.
3.3. Construct validity SHO-12 correlated strongly with the reference questionnaires: positively with modified HHS and negatively with OHS-12. (Table 1) (Fig. 2). 3.4. Internal coherence Internal coherence, measuring correlation between the 12 items, was “excellent”, with Cronbach alpha = 0.96. 3.5. Reproducibility Reproducibility was assessed on test-retest. Mean SHO-12 score on first administration was 63.1 ± 32.2 and 65.9 ± 31.9 on second;
the correlation was “strong”, with Pearson r = 0.86; p < 0.00001. Intraclass correlation was “excellent”, with = 0.86 [0.78–0.93]; p < 0.00001 (Fig. 3).
3.6. Feasibility The number of non-responses per item was 0 for questions 2, 3, 5, 6 and 8; 1 (1.6%) for questions 1, 4, 7 and 9, 4 (6.4%) for question 10 (“. . . when you are doing housework or gardening?”), 6 (9.7%) for question 11 (“. . . when you are taking a walk/hiking?”), and 20 (32.3%) for question 12 (“. . . when you are doing your favorite sport?”). Only 3 patients failed to answer all 3 questions 10, 11 and 12. The floor effect (percentage of patients scoring 0%: i.e.
Please cite this article in press as: Klouche S, et al. Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty. Orthop Traumatol Surg Res (2017), https://doi.org/10.1016/j.otsr.2018.04.010
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Fig. 2. Regression curves between SHO-12 and (a) HHS and (b) OHS-12.
Fig. 3. Reproducibility of SHO-12: Bland-Altman plot.
responding “mostly” to all questions) was 1.6%. The ceiling effect (percentage of patients scoring 100%: i.e. responding “never” to all questions) was 12.9%. The floor effect for OHS-12 and HHS was 0%; the ceiling effect was 0% for OHS-12, 34.9% for HHS-function and 49% for HHS-pain. Administration time as reported by patients ranged between 1 and 5–6 minutes. 3.7. Interest of the extra question The question on prosthesis awareness during sexual activity was answered by 45 patients (72.6%), which was more than for the question about sports (67.7%). These patients were significantly younger (p = 0.003). Seven patients spontaneously explained why they did not answer (vow of chastity, widowhood or “too old”): i.e. total response rate of 83.9% (52 patients). 4. Discussion The present study showed that the French-language version of the Forgotten Joint Score in THA is valid, coherent and comparable to the English-language version. No floor or ceiling effects emerged. The present mean follow-up of 1/6 years and mean forgottenhip score of 63.1% were comparable to those in the princeps study by Behrend et al. [5] (59.8% at a mean 2.6 years) and for the Dutch version of Shadid et al. [6] (56.1% at a mean 1.3 years). The present
rate of patients scoring 100% was 12.9%, compared to 8.8% in the study by Hamilton et al. [11] in a British population at 1 year’s follow-up. These scores are lower than those obtained on existing questionnaires. Self-assessment in terms of “awareness” of the prosthesis is very strict, providing more precise assessment of THA outcome. However, the validation study showed that the score correlated strongly with the two reference questionnaires (modified HHS and OHS-12). Overall, the item non-response rate was low. Questions about more physically demanding daily life activities, such as housework, hiking or sport, showed higher non-response rates. These patients seemed not to feel concerned by these questions. Score calculation, as explained by its designers [5], consists in dividing the total number of points by the number of questions answered; questionnaires are excluded from analysis if more than 4 questions are unanswered. This involves a loss of information, whence the interest of using a battery of validated self-administered questionnaires, as recommended for registries [22]. The English-language FJS does not originally include any item on implant awareness during sexual activity. In the present study, we added an extra question on this, to which 84% of patients responded, either directly (73%) or by making comments that were not required. Responses to this question were not included in calculating the SHO, so that the French version would remain strictly comparable to existing versions in other languages. On average, according to the meta-analysis by Issa et al. [3], 76.5% of patients reported pre-THA hip-related sexual problems. It is therefore important to assess satisfactory postoperative recovery of sexual activity, to evaluate surgical results and patient well-being. Nunley et al. [23] published a 13-item questionnaire dedicated to sexual activity, but without a score. We feel it is important for patients to answer the extra question in the SHO preoperatively and at the successive steps of follow-up, even if the results are not included in score calculation. The main limitation of the present study lies in its short followup. Hamilton et al. [24] demonstrated that the FJS-12 was more sensitive to changes occurring between 6 months and 1 year, with significantly greater effect size; the score can be expected not to remain constant over follow-up. The present study did not assess the SHO-12 questionnaire’s sensitivity to change, but the cohort is continuing to fill out the SHO-12 at subsequent follow-up timepoints so as to enable analysis of change in the future.
Please cite this article in press as: Klouche S, et al. Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty. Orthop Traumatol Surg Res (2017), https://doi.org/10.1016/j.otsr.2018.04.010
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5. Conclusion The French-language version of the Forgotten Joint Score in THA is valid, coherent, reproducible and comparable to the Englishlanguage version. It can thus be widely implemented to assess the extent to which THA is “forgotten” by French-speaking patients.
[5]
[6]
[7]
Funding source None. Authors’ contribution S Klouche: study methodology, questionnaire translation, statistical analysis, manuscript writing. JM Giesinger: cross-translation of the questionnaire, manuscript reading. E Sari-Ali: questionnaire translation, manuscript writing, study investigator, data collection. Disclosure of interest Johannes M. Giesinger is the copyright holder of the Forgotten Joint Score (FJS-12). The other authors declare that they have no competing interest.
[8]
[9] [10]
[11]
[12]
[13] [14]
[15]
Acknowledgments The authors thank Ms Marie-Agnès Davet, scientific secretary, for calling patients and sending out and receiving the questionnaires.
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Appendix A. Supplementary data
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Please cite this article in press as: Klouche S, et al. Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty. Orthop Traumatol Surg Res (2017), https://doi.org/10.1016/j.otsr.2018.04.010