Bone Marrow Transplantation (2002) 29, 41–49 2002 Nature Publishing Group All rights reserved 0268–3369/02 $25.00 www.nature.com/bmt Quality of life Translation and validation of the Functional Assessment of Cancer Therapy–Bone Marrow Transplant (FACT-BMT) Version 4 quality of life instrument into traditional Chinese AKL Lau1, CH Chang2,3, JWM Tai5, S Eremenco2,3, R Liang4,5, AKW Lie4,5, DYT Fong6 and CM Lau7 1 Department of Nursing Studies, the University of Hong Kong, Hong Kong Special Administrative Region, People’s Republic of China; 2Center on Outcomes, Research and Education, Evanston Northwestern Healthcare, Evanston, IL, USA; 3Institute for Health Services Research and Policy Studies, Northwestern University, Evanston, IL, USA; 4Department of Medicine, the University of Hong Kong, Hong Kong Special Administrative Region, People’s Republic of China; 5Bone Marrow Transplant Unit, Queen Mary Hospital, Hong Kong Special Administrative Region, People’s Republic of China; 6Clinical Trials Centre, the University of Hong Kong, Hong Kong Special Administrative Region, People’s Republic of China; and 7Centre for Education and Research in Family Medicine, the University of Hong Kong, Hong Kong Special Administrative Region, People’s Republic of China Summary: The need for a culturally sensitive instrument to assess quality of life (QOL) of patients in international oncology clinical trials has been well documented. This study was designed to evaluate the psychometric properties of the traditional Chinese translation (TCHI) of the Functional Assessment of Cancer Therapy–Bone Marrow Transplant (FACT-BMT) Version 4. The FACT-BMT consists of the FACT-General and treatment-specific concerns of bone marrow transplantation. The Chinese translation follows the standard Functional Assessment of Chronic Illness Therapy (FACIT) translation methodology. Bilingual teams from the United States and Hong Kong reviewed the translation to develop a provisional TCHI FACT-BMT, which was then pre-tested by interviewing 20 native Chinesespeaking BMT patients in Hong Kong. The pre-test results indicated good content coverage and overall comprehensibility. A refined translation, taking into account patient comments, was validated by 134 BMT patients in Hong Kong. The results indicated the high internal consistency of the TCHI FACT-BMT scales, with Cronbach’s alpha coefficients ranging from 0.71 (emotional well-being) to 0.92 (FACT-BMT total). The FACT-BMT also demonstrated good construct validity when correlated with SF-36 Health Survey scales. The QOL of Chinese BMT patients can now be evaluated using a well-validated international QOL instrument in their own language. Bone Marrow Transplantation (2002) 29, 41–49. DOI: 10.1038/sj/bmt/1703313 Correspondence: AKL Lau, Department of Nursing Studies, Faculty of Medicine, The University of Hong Kong, 21 Sassoon Rd, Pokfulam, Hong Kong Special Administrative Region, People’s Republic of China Received 18 April 2001; accepted 18 September 2001 Keywords: cross-cultural translation; quality of life instrument; bone marrow transplant; psychometric evaluation; FACT-BMT Bone marrow transplantation (BMT) has become increasingly important in the treatment of various haematological diseases. Advances in the areas of transplant immunology, human leukocyte antigen (HLA) testing, pre-BMT conditioning, and post-BMT care have improved the medical outcomes and survival rates of BMT patients. Attention must now extend beyond disease and symptom control (physical indicators) into an evaluation of overall quality of life (QOL) from the patient’s perspective (psychological indicators). When the goal of treatment is to improve the patient’s health status, QOL measurement is essential. QOL is subjective and multi-dimensional. Cella and Cherin1 offered a definition of health-related QOL that laid the groundwork for this measurement. QOL ‘refers to patients’ appraisal of and satisfaction with their current level of functioning as compared to what they perceive to be possible or ideal’. This definition was later modified to incorporate the multidimensionality of QOL: ‘Healthrelated quality of life refers to the extent to which one’s usual or expected physical, emotional and social well-being are affected by a medical condition or treatment’.2 Thus, QOL measurement should obtain the patient’s perspective and encompass physical, mental and social well-being. QOL measures typically consist of several major domains, including the physical, functional, emotional and social.3,4 The physical domain refers to disease, symptoms and treatment side-effects. The functional domain primarily reflects one’s capabilities, role limitations and self-care. The emotional domain includes emotional distress and positive emotional experiences. The social domain relates to intimacy, sexuality and family relationships, as well as the extended friendship network and the amount of support and help that patients obtain from their social networks. Translation into Chinese of a QOL instrument AKL Lau et al 42 Several studies have indicated that BMT is associated with many psychological and physical threats to the QOL of patients.5,6 Unfortunately, few instruments have been specifically designed to measure the QOL of Chinese BMT patients. The few that exist were developed in Englishspeaking countries, and their validity and reliability have principally been established on Western populations.7,8 The need for a culturally sensitive instrument to assess the QOL of patients in international oncology clinical trials has been well documented.9 To enable clinicians and researchers to study the QOL of Chinese BMT patients within and across cultures, a linguistically and culturally equivalent QOL instrument must be developed. The Functional Assessment of Cancer Therapy–Bone Marrow Transplant (FACT-BMT) Version 4 is a selfadministered instrument designed to assess multidimensional aspects of the QOL in BMT patients. It consists of the 27-item FACT-General (FACT-G) and the 23item Bone Marrow Transplantation Subscale (BMTS). The FACT-G assesses four primary dimensions of QOL, including physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and functional well-being (7 items). A five point Likert-type response scale ranging from 0 to 4 is used (0 = ‘not at all’; 1 = ‘a little bit’; 2 = ‘somewhat’; 3 = ‘quite a bit’; and 4 = ‘very much’). The original FACT-BMT was developed in English using a standardised approach for item derivation, reduction and testing,7 and has been used extensively in various clinical trials.10–12 The FACT-BMT was initially translated and validated in Spanish,13 Dutch, French, German, Italian, Norwegian and Swedish,14 and subsequently translated into Japanese, Portuguese and Russian.15 The FACT-G Version 3 was translated into traditional Chinese and tested by Yu et al16 between 1996 and 1999. This team employed the double-back translation method, which is less rigorous compared to the standard FACIT translation methodology as outlined in Table 1. Their use of focus groups to explore the cultural equivalence of the Chinese FACT-G translation was dubious. The success of a focus group depends upon many important factors, such as the selection of group participants and the handling of group dynamics.17 A dominance of nasopharyneal carcinoma patients participating in the two focus groups raises questions about their representativeness. The Hong Kong Chinese Version World Health Organization QOL measure, abbreviated version WHOQOL-BREF (HK) was used by Yu’s team16 to perform convergent validity. The subscale correlations Table 1 between the FACT-G and the WHOQOL-BREF (HK) were found to be low, and the team eventually had to acknowledge that the evidence concerning convergent validity was weak.16 The original FACT-G English Version 3 was updated to Version 4 in 1997 due to the translation and validation of the FACT-G into more than 20 languages. These changes involved the de-centering14 of item wording so that the English source would more closely correspond to the translations both in terms of semantic equivalence and cultural relevance.18 One noticeable change was that Version 4 excluded the two ‘Relationship with Doctor’ items from the FACT-G.15 This is particularly suitable in Hong Kong, where the doctor–patient relationship is different from that in the US.19 Other changes in Version 4 include item wording, item numbering and scoring.15 Because of these changes, a new traditional Chinese translation following well-established FACIT translation methodology was required; hence, our development of the TCHI FACT BMT Version 4. Learning the modern Chinese language has been equated to a ‘Herculean chore’,20 and translating it is no easy task either. As Vernon21 has pointed out, ‘Chinese . . . represents every different word by an ideograph, or pictorial character, and there are some 3500 of these characters to be learned. Each character contains two parts: one is the stem . . . the other is the radical . . . . Some 80 per cent of characters contain one of 214 radicals.’ To complicate matters, Chinese words are made up of single or, more commonly, double or triple characters. These word-characters must then be combined in various patterns to depict new concepts.20 The traditional form of Chinese characters is used in Hong Kong, Taiwan, and other Chinese communities, while the simplified form is primarily used in mainland China and Singapore. The simplified form is an attempt, as its name implies, to simplify those characters required for day to day reading and writing. The introduction of the simplified form and Putonghua (the official Chinese language) in mainland China was intended to reduce inter-ethnic and regional differences.22–24 Another intention was to eliminate the problem of having dozens of dialects, which can be mutually unintelligible in different regions. Despite efforts made since 1956, ‘dialects cannot be abolished by administrative order’,25 for regionality and local roots are traditionally respected by most Chinese, and individuals are highly reluctant to abandon their dialects.26 Consequently, most people have become bilingual, and can speak their own regional dialect and Putonghua. Translation methodology Step Task 1 Forward-translation: English → target 2 3 4 5 6 Reconciliation Back-translation: Target → English Independent reviews Character and grammar verification Pretesting with patients Bone Marrow Transplantation Personnel Requirements/Purposes 2 native speakers of target language (1 in the US and 1 in native country) 1 native speaker, familiar with multiple dialects 1 native English speaker 3–4 bilingual experts and coordinating team Language co-ordinator and bilingual expert Native speaking patients (15–30) with relevant diagnosis Use simple language and capture meaning Resolve discrepancies Use simple language Review steps 1–3 and finalise translations Proof-read Assess comprehension and acceptability Translation into Chinese of a QOL instrument AKL Lau et al When one starts to feel confused about ‘the Chinese’ and their languages, paradoxically one actually gets a better feel for what researchers have faced during the translation and validation of any instrument into Chinese. Although simplified Chinese versions of the FACIT scales are also being developed and tested, this paper alone describes an international collaboration between the US and Hong Kong teams to translate and validate the FACT-BMT Version 4 into traditional Chinese. Materials and methods Marrow Transplant Unit at the Queen Mary Hospital, which is affiliated with the University of Hong Kong. The inclusion criteria were: patients must have undergone BMT; they must have been aged 18 years or older; they must have been able to read and write Chinese; and they must have consented to participate in the study. The Chinese version was distributed to these patients during their follow-up clinic visit. Patients were asked to self-administer the questionnaire, and most of them were able to complete it without any assistance. Each patient was then interviewed and asked to comment on the comprehensiveness and clarity of the items, and the degree of difficulty encountered when answering the questionnaire. Development of a provisional traditional Chinese FACTBMT Version 4 for pre-testing Validation study The 27-item FACT-G Version 4 was translated into a traditional Chinese character (TCHI) version by employing the standard FACIT translation methodology14 (see Table 1), which is a more rigorous version of the doubleback translation method,27 and is ‘superior to single translation and translation by committee’.14 Although only 12 out of 23 bone marrow transplant subscale (BMTS) items are used to derive the BMTS score,7 all 23 items were translated. Firstly, two Chinese-speaking professional translators performed the forward-translation from English into traditional Chinese. Secondly, an independent native Chinese speaker reconciled the forwardtranslations by either choosing the best alternative of the two forward-translations, combining them, or suggesting another translation when necessary. Thirdly, a native English-speaking professional translator designated by the Center on Outcomes, Research and Education (CORE), in Evanston, IL, US, was asked to translate the reconciled version back into English (back-translation). The CORE translation team then compared the back-translation with the English source to ensure content and semantic equivalence and identify potential problems in the reconciled version. Finally, three independent native Chinese speakers (two from Hong Kong and one from the US but a native of Taiwan) reviewed the item history, which included all of the forward-translations, the reconciliation, and the backtranslation. The reviewers were asked to work independently and to consider simple language that would easily be understood by BMT patients with diverse levels of education. They either selected the most appropriate translation for each item from the reconciled and independent forwardtranslations, or provided alternative translations to improve item content and comprehensibility when necessary. All of their recommendations were discussed and evaluated extensively by the multi-national translation teams from the US and Hong Kong. Consequently, a provisional Chinese version was developed. This translation was then submitted to the language co-ordinator for grammar and character verification before testing. To further examine the psychometric properties and clinical applications of the TCHI FACT-BMT Version 4 after pretesting, a larger study was conducted. Ethical approval was obtained from the research committee of the chosen hospital. Eligible patients were identified from medical records and were sent a package containing an invitation to participate, a consent form, a stamped return envelope, the final TCHI FACT-BMT Version 4, and the Chinese (HK) version of Medical Outcomes Study 36-Item Short Form Health Survey (SF-36).28–30 The SF-36 is a generic health status measure, derived from a battery of items included in the RAND/Medical Outcomes Study. Thirty-five of the items assess eight dimensions of health including: physical functioning (10 items), role limitations due to physical health problems (4 items), bodily pain (2 items), general health (5 items), mental health (5 items), role limitations due to emotional problems (3 items), social functioning (2 items) and vitality (4 items). The remaining item asks respondents about health changes over the past year that are not currently scored. All BMT patients were included, with the exception of those for whom transplantation had occurred less than 1 year previously. The literature has shown that the latter group was more compromised in terms of physical functioning and psychological status.31 As McQuellon et al12 noted, physical well-being and functional well-being are adversely affected in the short term by bone marrow transplantation. Scores are known to change notably for patients assessed initially when they are symptomatic and subsequently when they are free of symptoms.32 Recruiting such patients would have introduced ‘atypical cases’ to our sample. Such an inclusion will be more useful when we ‘seek to compare extremes of a phenomenon in order to generate hypotheses about it’.17 The patients in our validation study included those with chronic myelogenous leukaemia (CML), acute myeloblastic leukaemia (AML), acute lymphocytic leukaemia (ALL), non-Hodgkin’s lymphoma (NHL), multiple myeloma, and miscellaneous conditions. Patients who did not respond within 3 weeks were telephoned and again asked to participate. Pre-testing Statistical analysis The provisional version of the TCHI FACT-BMT Version 4 was pre-tested on 20 patients recruited from the Bone The demographic and clinical characteristics of the validation sample (n = 134) were summarised by descriptive 43 Bone Marrow Transplantation Translation into Chinese of a QOL instrument AKL Lau et al 44 statistics. The construct validity of the TCHI FACT-BMT Version 4 was first studied by examining the internal consistency of the subscales. Specifically, Cronbach’s ␣ coefficients were obtained from the validation sample and were compared to those from the original English validation sample. The reliability coefficients of the FACT-G scales obtained from this translated version were also compared to those reported by Yu et al.16 Inter-scale correlations among the TCHI FACT-BMT domains as well as the correlations between these and SF-36 were also obtained and evaluated by Spearman’s rank correlation coefficients. A correlation coefficient of at least 0.4 was considered as practically relevant. Finally, the sensitivity of the TCHI FACT-BMT was examined by comparing FACT-BMT scores between patients with and without any pulmonary diseases who were expected to differ in their QOL scores. To examine the difference, the two-sample t-test was used when normal distribution was appropriate, otherwise the nonparametric Wilcoxon rank sum test was adopted. A 0.05 level of significance was used for all significance tests, and the Statistical Analysis System (SAS) Version 8.0 was used for all statistical analyses. Results Translation and pre-testing Among the 23 BMT-specific items, seven required refinement during the translation process, and modifications were made to improve their comprehensibility (see Table 2). Overall, patients commented that the TCHI FACT-BMT Version 4 was easy to complete and the items were relevant. Most patients appeared not to have resumed sexual activity after BMT, and found it difficult to comment on this aspect of the questionnaire. Most patients felt uneasy Table 2 responding to item GE5 (‘I worry about dying’) and item GE6 (‘I worry that my condition will get worse’). This suggests that a high proportion of patients use avoidance as a coping mechanism, and it highlights the local belief that talking about death or any unfavourable outcome is ‘bad luck’. Reliability coefficients (Cronbach’s ␣) also indicated acceptable internal consistency, which suggested that these translated items performed well with the rest of the items in the same scale. Validation study Out of the 201 TCHI FACT-BMT Version 4 questionnaires that were distributed, 134 (66.6%) were returned. The demographic and clinical characteristics of the validation sample are listed in Table 3. The median time since BMT was 4.0 years, with a range from 1.1 to 9.8 years. Of the patients, 69.4% were aged between 31 and 50. Of these, 60.5% had been educated to secondary school level, and 21.6% had reached tertiary level or above; 62.7% had no religious background. The diagnoses in the study sample were mixed, and included acute leukaemia (n = 52), chronic leukaemia (n = 47), lymphoma (n = 19), and others (n = 16). The internal consistency (Cronbach’s ␣ coefficient) of the TCHI FACT-BMT Version 4 subscales for the validation sample were summarised and compared with those of the original English Version 37 and the traditional Chinese Version 316 (see Table 4). The internal consistency of the TCHI FACT-BMT Version 4 was universally higher than the English version in all subscales, which indicated that its structure was generally comparable with the original English Version 3. When the item ‘I worry that my condition will get worse’ was added to the emotional well-being subscale in Version Improvements made to increase comprehensibility of the BMT-specific items during translation Item No. Item content BMT 4 The effects of treatment are worse than I had imagined BMT5 I am able to get around by myself BMT8 I have confidence in my nurse(s) BMT13 I am bothered by a change in the way food tastes B1 I have been short of breath BMT16 I have trouble with my bowels BMT17 My illness is a personal hardship for my close family members Bone Marrow Transplantation Problems and actions taken to improve comprehensibility With reference to the BMT development and validation, the phrase ‘effects of treatment’ refers to the side-effects of the treatment. In the original Chinese translation, the word ‘effects’ can imply results. Therefore, ‘sideeffects’ replaced. The phrase ‘get around’ has a different meaning in Chinese. It can also express ‘to move about’. The original English implies that the patient can move about by himself. Therefore, the final version was rewritten as: ‘I am able to move around by myself’. The statement becomes plural by combining the translation and the reconciled version, as there will be more than one nurse to take care of the patient. The final amendment reads: ‘I have confidence in the nurse(s) who take care of me’. The statement refers to the perception of taste. Therefore, the final version implies ‘I am bothered by the change of taste’. The word ‘short of breath’ has a different colloquial interpretation in Chinese. This word caused some difficulty in the back-translation. The final version states: ‘When I breathe, I have not enough breath’. There is different interpretation of the word ‘bowels’. This can imply ‘bowel movement’ or ‘trouble with stomach and intestinal discomfort’. The final version reads: ‘I have trouble with stomach and intestinal discomfort’. In the original item, the illness is the personal hardship of close family members. The final version reads: ‘My illness causes my close family personal hardship’. Translation into Chinese of a QOL instrument AKL Lau et al Table 3 Demographic and clinical characteristics of the validation sample (n = 134) Demographic Gender Male Female Age 18–30 31–50 51–65 Education Primary Secondary Tertiary or above Others Religion Buddhism Catholicism Chinese idols Christian None Clinical characteristic Leukaemia type Acute leukaemic Chronic leukaemic Lymphoma Others Conditioning regimen Chemotherapy + radiotherapy Chemotherapy only Type of BMT Allo Auto Table 4 n % 76 58 56.7 43.3 25 93 16 18.7 69.4 11.9 21 81 29 3 15.7 60.5 21.6 2.2 21 11 1 17 84 15.7 8.2 0.8 12.7 62.7 52 47 19 16 38.8 35.1 14.2 11.9 45 89 33.6 66.4 111 23 82.8 17.2 4, the alpha coefficient improved (␣ = 0.78) as compared to the original five-item scale (␣ = 0.67) in Version 3. The alpha coefficient (␣ = 0.9) of the total score of the 27-item Chinese FACT-G Version 4, excluding the two ‘Relationship with Doctor’ items and with the addition of one emotional well-being item, was comparable to the full 28item English Version 3 (␣ = 0.88). There was no change in the alpha coefficient (0.92) of the traditional Chinese version when the items ‘I have concerns about my ability to have children’ and ‘I regret having the bone marrow transplant’ were set aside from the BMTS, but there existed a slight change, from 0.89 to 0.90, in the English version. Overall, the alpha coefficients of the TCHI FACT-BMT Version 4 were universally higher than those of the English Version 3. As can be seen in Table 4, all alpha coefficients of the TCHI FACT-G Version 4 are higher than those reported by Yu et al16 for Version 3. Construct (concurrent) validity was evaluated by examining the inter-scale correlations of the FACT-BMT itself, and their correlation with the SF-36. Most FACT-BMT subscales correlated moderately (r ⬎ 0.40) with the SF-36 scales (see Table 5), which indicated a relatively high degree of concurrent validity. Criterion-related validity was also tested by the use of FACT-BMT scores to distinguish groups known to differ from one another (known-group comparison). The differences in FACT-BMT scores between patients with and without pulmonary disease are summarised in Table 6. Significant differences were found, except for social/family well-being, functional well-being and emotional well-being. In general, patients without pulmonary disease scored higher in all subscales of FACTBMT. 45 Descriptive statistics of the traditional Chinese and original English language versions of the FACT-BMT Version 4 Version 3 Validation (n = 134) Mean (s.d.) Alpha coefficients PWB (7 items) SFWB (7 items) RWD (2 items) EWB (5 items) EWB (6 items)a,1 FWB (7 items) FACT-G Total (28 items) FACT-G Total (27 items)2 BMTS (12 items) BMTS (10 items)3 TOI (PWB + FWB + 10-item BMTS) (24 items) FACT-BMT total (12 BMTS) (39 items) FACT-BMT total (10 BMTS) (37 items) Englishb (n = 182) Mean (s.d.) Alpha coefficients Chinesec (n = 1108) Mean (s.d.) Alpha coefficients 22.1 (4.8) 20.4 (5.3) — 15.6 (3.2) 18.3 (4.1) 19.2 (5.3) — 79.5 (14.3) 28.5 (6.0) 27.3 (5.9) 68.2 (13.7) 0.84 0.83 — 0.71 0.78 0.85 — 0.90 0.64 0.74 0.90 21.6 (5.3) 24.0 (3.8) 7.3 (1.1) 15.2 (3.1) — 17.7 (5.5) 85.8 (13.6) — 35.3 (5.6) 27.9 (5.4) 67.2 (13.8) 0.84 0.69 0.62 0.67 — 0.78 0.88 — 0.60 0.63 0.87 21.8 19.3 4.8 13.7 (5.5) (4.6) (1.8) (4.0) — 13.7 (5.9) 73.4 (14.4) — — — — 0.75 0.53 0.37 0.65 — 0.75 0.85 — — — — 108.0 (19.8) 106.6 (19.7) 0.92 0.92 121.0 (18.0) 113.7 (17.9) 0.89 0.90 — — — — PWB = Physical Well-being; SFWB = Social/Family Well-being; RWD = Relationship with Doctor; EWB = Emotional Well-being; FWB = Functional Well-being; BMTS = Bone Marrow Transplant Subscale; and TOI = Treatment Outcome Index. a Consistent with the scoring published in the FACT Version 4 manual, the following clarifications are offered: 1The item ‘I worry that my condition will get worse’ is added to the Emotional Well-Being scale. 2Six-item Emotional Well-being is used, and two Relationship with Doctor items are excluded. 3 ‘I have concerns about my ability to have children’ and ‘I regret having the bone marrow transplant’ have been set aside in the statistical analysis. b From McQuellon et al.7 c From Yu et al16 — = not applicable. Bone Marrow Transplantation Translation into Chinese of a QOL instrument AKL Lau et al 46 Table 5 Construct (concurrent) validity coefficients (n = 134) FACT-BMT SF-36 PWB SFWB EWB FWB FACTG BMT TOI FACTBMT PF RP BP GH VT SF RE MH 1 0.37 1 0.50 0.34 1 0.48 0.49 0.49 1 0.75 0.73 0.73 0.78 1 0.66 0.61 0.64 0.65 0.84 1 0.80 0.60 0.65 0.80 0.93 0.93 1 0.75 0.73 0.72 0.77 0.98 0.92 0.97 1 0.52 0.20 0.27 0.47 0.49 0.32 0.51 0.46 0.54 0.19 0.31 0.41 0.45 0.42 0.52 0.46 0.59 0.25 0.30 0.42 0.52 0.47 0.55 0.52 0.56 0.22 0.35 0.34 0.49 0.42 0.52 0.49 0.61 0.42 0.39 0.53 0.61 0.52 0.61 0.60 0.48 0.34 0.37 0.63 0.59 0.57 0.65 0.60 0.45 0.37 0.44 0.57 0.57 0.51 0.59 0.57 0.47 0.47 0.60 0.57 0.65 0.60 0.64 0.66 1 0.53 1 0.55 0.46 1 0.49 0.36 0.41 1 0.43 0.30 0.48 0.50 1 0.46 0.54 0.44 0.37 0.45 1 0.37 0.54 0.30 0.35 0.42 0.57 1 0.19 0.29 0.34 0.27 0.52 0.50 0.56 1 FACT-BMT PWB SFWB EWB FWB FACTG BMT TOI FACT-BMT SF-36 PF RP BP GH VT SF RE MH All correlations were significant at the 0.05 level. PWB = Physical Well-being; SFWB = Social/Family Well-being; RWD = Relationship with Doctor; EWB = Emotional Well-being; FWB = Functional Well-being; BMTS = Bone Marrow Transplant Subscale; TOI = Treatment Outcome Index; PF = physical functioning; RP = role limitations due to physical health problems; BP = bodily pain; GH = general health; VT = vitality; SF = social functioning; RE = role limitations due to emotional problems; and MH = mental health. a The item ‘I worry that my condition will get worse’ is added to the Emotional Well-being scale. b ‘I have concerns about my ability to have children’ and ‘I regret having the bone marrow transplant’ have been set aside in the statistical analysis. Table 6 FACT-BMT group comparisons Without pulmonary disease (n = 119) Physical Well-being (7 items) Social/Family Well-being (7 items) Emotional Well-being (6 items)a Functional Well-being (7 items) FACT-G Total (27 items)3 Bone Marrow Transplant Subscale (10 items)b TOI (PWB + FWB + 10-item BMTS) (24 items) FACT-BMT Total (10 BMTS) With pulmonary disease (n = 15) P value Mean s.d. Mean s.d. 22.6 20.6 18.4 19.4 80.7 27.7 4.3 5.2 4.0 5.3 13.8 5.7 17.9 18.5 17.3 17.7 71.3 24.2 6.2 5.8 4.3 4.9 15.7 6.9 0.010 0.194 0.370 0.224 0.017 0.031 69.4 13.1 59.7 15.2 0.010 108.3 18.9 95.5 22.1 0.019 Higher scores reflect better quality of life. a The item ‘I worry that my condition will get worse’ is added to the Emotional Well-being scale. b ‘I have concerns about my ability to have children’ and ‘I regret having the bone marrow transplant’ have been set aside in the statistical analysis. Discussion This paper reports an international collaboration between multilingual translation teams in the US and Hong Kong to translate and validate the FACT-BMT Version 4 into traditional Chinese (TCHI). The translation complied with the FACIT translation methodology. The backtranslations of some revised modified items were found to Bone Marrow Transplantation be satisfactory when compared to the original English version. The results of pre-testing demonstrated the satisfactory reliability of the subscales of the translated version. The patients were able to complete the questionnaire by themselves, and commented that the TCHI FACT-BMT Version 4 was easy to understand and the items were relevant to measuring health-related QOL. The results suggest that TCHI FACT-BMT can be Translation into Chinese of a QOL instrument AKL Lau et al applied to measure QOL in patients undergoing BMT in Hong Kong and other places where traditional Chinese characters are still in use. There are good reasons to believe that it can also be applied in mainland China, where simplified Chinese characters are used. As Chen33 has explained in Modern Chinese History and Sociolinguistics: ‘While it takes some time for people trained in simplified script to learn to write in the complicated [or traditional] one, a reading knowledge of the other type of script is very easy to acquire. In correspondence between people from mainland China and elsewhere, handwritten characters in different styles are rarely reported to cause any problems in comprehension. Difficulties in comprehension due to the differences between the complicated [or traditional] and the simplified characters have been exaggerated’ (material in brackets added). The second reason is that simplified characters have not completely replaced traditional Chinese characters. The general public has found it difficult to accept so many unfamiliar simplified characters within a limited period of time. As Chen has noted,33 an effective writing system should strike a balance between ease of production and ease of recognition. While a reduction in the number of strokes makes characters easier to write, it makes them less differentiated from each other and thus less easy to recognise. Simplification makes life easier for the writer, but more difficult for the reader. However, even though it will be possible to use the traditional Chinese version in mainland China, a well-translated simplified Chinese character version is still needed. The development of such a translation will be discussed elsewhere. The results from the psychometric evaluation of the TCHI FACT-BMT Version 4 indicated that its scale structure was generally similar to its original English version. The alpha coefficients of all subscales obtained from the validation sample (n = 134) were universally higher than those from the original English Version 3 sample. It is also noticeable that all alpha coefficients of the TCHI FACT-G Version 4 were consistently higher than those reported by Yu et al,16 which indicates its better psychometric performance. Both concurrent and criterion validity also showed good construct validity. This study illustrated that the TCHI FACT-BMT Version 4 is comparable to the original English version, and better than the traditional Chinese FACT-G Version 3. Cross-cultural comparisons are not as simple as one might expect. The creation of a QOL instrument that can be translated and validated in different cultures does not automatically warrant valid and meaningful comparisons across those cultures. People in different cultures and societies have different sets of values and are likely to consider different criteria when judging their own QOL. This cultural relativism points us to the idea that there are alternative paths that can accommodate human needs and desires.34 In Chinese culture, where the relational and interdependent aspects of the self predominate, self-evaluation is based to a significant degree on external, social information rather than the private experiences (eg emotion) of, for instance, an American individual.35 The path to one’s ideal QOL is thus different in Chinese and American cultures. In American culture it may be the pursuit of happiness. While in Chinese culture, personal happiness occupies a less salient position. For happiness and unhappiness are seen to stem from a common ‘root’,36 which is a Confucian concept. Unhappiness is believed to arrive on the heel of happiness, and vice versa. An individual’s gain of happiness means the loss of happiness by another individual. Happiness, therefore, should not be embraced with excessive joy while unhappiness of the moment should be endured for happiness is just around the corner.35 ‘How am I viewed by others?’ is a more salient concern in East Asian cultures,37 while in America it is ‘this is what I think’, with the often overly positive views about the self.38–40 When an American reports ‘I feel good’ or ‘I lead a good life’, one may wonder whether this is how the individual wishes to view himself41 or whether self-deceptive mechanisms have been involved.42 When similar answers are given by a Chinese individual, is it because of social desirability bias, or because of a suspicion that the interviewers are part of a surveillance system of the Chinese government?17 We are a long way from claiming any success in making crosscultural comparisons of the QOL of BMT patient, but we have taken a step closer to such comparisons.43 This is the first study on the QOL of Chinese BMT survivors as measured by the TCHI FACT-BMT Version 4. One of the study limitations is related to the relatively small sample, and the unequal sample size in each disease group. This hindered the possibility of drawing powerful conclusions in terms of cross-group comparisons. A larger sample size of patients in each subtype of leukaemia would have facilitated conclusions about how different types of disease affect patient responses. Another limitation is that this study has not examined the stability or test–retest reliability of the instrument due to the unavailability of data from a second assessment. Longitudinal data collection is underway, and the TCHI FACT-BMT’s measurement stability will be evaluated. Based on our previous experiences and reported results of the English version7 we are confident that the test–retest reliability will be high and statistically significant. The results will be reported elsewhere when data become available. Finally, a prospective longitudinal study is underway to examine the responsiveness of the TCHI FACT-BMT Version 4 over time. In conclusion, the international collaboration between the US and Hong Kong teams has enhanced the development of a culturally specific Chinese QOL instrument for Chinese BMT survivors. Despite difficulties in translation and the cultural differences mentioned above, the TCHI FACTBMT Version 4 has high internal consistency and good overall comprehensibility. It is a well translated and psychometrically valid tool to assess the QOL of Chinese BMT patients. 47 Acknowledgements We wish to thank all of the patients at the Bone Marrow Transplant Unit, Queen Mary Hospital, for their participation. We wish also to thank the two anonymous referees for their valuable comments and suggestions. 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