Translation and validation of non-English versions of the Ankylosing Spondylitis Quality of Life (ASQOL) questionnaire

Background  

The Ankylosing Spondylitis Quality of Life (ASQOL) questionnaire is a unidimensional, disease-specific measure developed in the UK and the Netherlands. This study describes its adaptation into other languages.     

Validation of the Ankylosing Spondylitis Quality of Life questionnaire in Tunisian language

Background: The Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire is a Wide-world used, unidimensional, disease-specific measure of quality of life. Arabic or Tunisian versions of ASQoL or any other quality of life index are not provided. Aim: To adapt the Ankylosing Spondylitis Qhality of life Questionnaire (ASQoL) for use in Tunisian and to test its reliability and validity. Methods: 99 patients who fulfilled the modified New York criteria for ankylosing spondylitis (AS) were included in this study (84 male and 15 female). The translation process included the recent guidelines for cross-cultural adaptation. Reliability of the Tunisian version of the ASQoL was assessed by test-retest method (day 1 and day 10) and internal consistency using Cronbach's alpha coefficient. For construct validity, ASQoL scores were correlated with specific instruments of AS. Results: The mean age of patients was 38.35 years ± 12.26 (18- 73) and the mean disease duration was 11.3 years ± 9.4 (0.6 - 40). The mean time to complete the questionnaire was 5 minutes. Reproducibility was good with no significant difference between ASQoL0 (mean score = 9.8 ± 5.04) and ASQoL10 (mean score = 9.46 ± 5.89) as well as the statically significant positive correlation intra-class coefficient: 0.87 (IC 95%: 0.79-0.92). Internal consistency was good (Cronbach: 0.933; IC95%=0.86-0.95). ASQoL was significantly correlated with BASDAI (p<0.001), BASFI (p<0.001), BASG-s (p<0.001), BASMI (p=0.026), MASES (p=0.024) and all items of SF-36. Conclusion: Validation of the ASQoL for use in Tunisia was successful. The results of the present study indicate that the Tunisian version for ASQoL is reliable and valid.     

Validation of the Ankylosing Spondylitis Quality of Life assessment tool in patients with non-radiographic axial spondyloarthritis

Quality of Life Research - To evaluate the psychometric performance of the Ankylosing Spondylitis Quality of Life (ASQoL) scale in patients with non-radiographic axial spondyloarthritis (nr-axSpA)...     

Translation validation of a new back pain screening questionnaire (the STarT Back Screening Tool) in French

Background

Low back pain (LBP) is a major public health problem and the identification of individuals at risk of persistent LBP poses substantial challenges to clinical management. The STarT Back questionnaire is a validated nine-item patient self-report questionnaire that classifies patients with LBP at low, medium or high-risk of poor prognosis for persistent non-specific LBP. The objective of this study was to translate and cross-culturally adapt the English version of the STarT Back questionnaire into French.

Methods

The translation was performed using best practice translation guidelines. The following phases were performed: contact with the STarT Back questionnaire developers, initial translations (English into French), synthesis, back translations, expert committee review, test of the pre-final version on 44 individuals with LBP, final version.

Results

The linguistic translation required minor semantic alterations. The participants interviewed indicated that all items of the questionnaire were globally clear and comprehensible. However, 6 subjects (14%) wondered if two questions were related to back pain or general health. After discussion within the expert committee and with the developer of the STarT Back tool, it was decided to modify the questionnaire and to add a reference to back pain in these two questions.

Conclusions

The French version of the STarT Back questionnaire has been shown to be comprehensible and adapted to the French speaking general population. Investigations are now required to test the psychometric properties (reliability, internal and external validity, responsiveness) of this translated version of the questionnaire.     

Effects of Intravenous Golimumab on Health-Related Quality of Life in Patients with Ankylosing Spondylitis: 28-Week Results of the GO-ALIVE Trial

ObjectiveEvaluate the effect of intravenous golimumab on health-related quality of life (HRQoL) in patients with ankylosing spondylitis (AS) through week 28 of the phase III, multicenter, randomized, double-blind, placebo-controlled GO-ALIVE study.MethodsAdult patients (n = 208) were randomized to IV golimumab 2 mg/kg (n = 105) at weeks 0, 4, and 12 and every 8 weeks or placebo (n = 103) at weeks 0, 4, and 12, with crossover to golimumab 2mg/kg at weeks 16, 20, and every 8 weeks. General HRQoL was evaluated using the Short Form Health Survey (SF-36) Physical Component Summary/Mental Component Summary (PCS/MCS), and the EQ VAS, and AS disease–specific HRQoL was assessed using the Ankylosing Spondylitis Quality of Life (ASQoL) instrument.ResultsMean improvements from baseline in SF-36 PCS were greater in the golimumab group versus the placebo group at weeks 8 and 16 (6.8 vs 2.1 and 8.5 vs 2.9, respectively; P < .001); similar results were observed for SF-36 MCS (5.6 vs 1.7 and 6.5 vs 0.8, respectively; P < .001). Mean improvement in each of 8 subscale scores of the SF-36 were also greater for golimumab-treated patients versus placebo at weeks 8 and 16. Mean improvements in EQ VAS and ASQoL were greater in the golimumab group versus placebo at week 8 and week 16. Greater proportions of golimumab-treated patients had clinically meaningful improvement in SF-36 PCS, SF-36 MCS, EQ VAS, and ASQoL at weeks 8 and 16; improvements in SF-36 PCS/MCS, EQ VAS, and ASQoL were maintained through week 28.ConclusionsGolimumab-treated patients had greater mean improvements in HRQoL measures compared with placebo through week 16. Clinically meaningful improvements were observed as early as week 8 and continued through week 28.     

Quality of sexual life and satisfaction in female partners of men with ED: psychometric validation of the Index of Sexual Life (ISL) questionnaire

Effective treatments for erectile dysfunction (ED) are available, however, reestablishing erectile function does not necessarily reestablish a satisfying sexual relationship. To assess broader influences on treatment discontinuation than pure efficacy, we developed and psychometrically validated the Index of Sexual Life (ISL) to measure the impact of ED on female partners' sexuality. This 11-item instrument measures sexual life satisfaction, sexual drive and general life satisfaction. Good construct validity, criterion validity, and reproducibility were demonstrated. Female partners of men with ED report significantly lower levels of sexual satisfaction and sexual drive than those without ED. The ISL is successfully validated.     

Surgery in the Treatment of Rheumatoid Arthritis and Ankylosing Spondylitis

The pain, deformities and disabilities resulting from rheumatoid arthritis and ankylosing spondylitis must be treated by a team composed of physician, physical medicine expert, orthopædic surgeon, and, in certain cases, deep X-ray therapist working simultaneously.The principle of “rest” in order to relieve pain has to be combined with methods designed to preserve and restore function. The multiple joint deformities in these cases may necessitate a long programme of reconstructive or functional treatment, which entails whole-hearted co-operation on the part of the patient in intensive post-operative exercise regime.Procedures advocated for the upper limb include excision of the acromion process together with the subacromial bursa to allow free movement between the central tendon of the deltoid and the tendinous shoulder cuff: arthrodesis of the shoulder in cases where there is more severe joint destruction: in certain cases of elbow-joint arthritis, excision of the radial head and sub-total synovectomy may preserve joint function and avoid or delay the necessity for arthroplasty which can be carried out in two ways: (a) similar to the formal joint excision, or (b) re-shaping the lower end of the humerus and upper end of the ulna lining these surfaces with fascia. The former method is preferable in cases of rheumatoid arthritis. To overcome wrist-joint deformity and restore pronation and supination excision of the lower end of the ulna together with radiocarpal fusion in position for optimum function is advocated. Finger and toe joints may be corrected by resection of the bone ends and capsulectomy.In the lower limbs bilateral involvement of the hip-joint is best treated by vitallium mould arthroplasty which may be carried out in four ways: (1) Routine arthroplasty; (2) Modified Whitman procedure; (3) Modified Colonna operation; and (4) The proximal shaft or intertrochanteric arthroplasty. It is essential in these operations to have knowledge of the operative technique, the use of special hip gouges and reamers, and detailed post-operative supervision.For dorsal kyphosis of the spine, spinal osteotomy at the lumbar level provides excellent correction but is an operation demanding care and skill in its execution.The author''s remarks are based on experience gained when working with Dr. M. N. Smith-Petersen at the Massachusetts General Hospital, Boston, U.S.A.     

Psychometric validation of the German translation of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in patients with reflux disease

Background  

Symptoms of heartburn has an impact on health-related quality of life (HRQL). When a questionnaire is translated into a new language, a linguistic validation is necessary but not sufficient unless the psychometric characteristics have been verified. The aim is to document the psychometric characteristics of the German translation of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire.     

Validation of the genital herpes treatment satisfaction questionnaire (GHerpTSQ) in status and change versions

A new measure of treatment satisfaction (GHerpTSQ) for recurrent genital herpes simplex virus (HSV) was validated and used to evaluate two therapeutic strategies widely used for the management of HSV: episodic treatment, where individual herpes outbreaks are treated as they arise; suppressive therapy, where treatment is taken daily to prevent HSV outbreaks. Satisfaction with treatment is important since daily dosing with suppressive therapy is necessary in the absence of symptoms. A 12-item questionnaire was designed using a modified form of the Diabetes treatment satisfaction questionnaire (DTSQ). The psychometric properties of the GHerpTSQ were evaluated within a sample of 125 Canadians with a history of HSV (type 1, 2) infection participating in a 48 week randomised cross-over trial. Factor analysis suggested that the items can be analysed as two separate subscales corresponding to Control/effectiveness, and Convenience/lifestyle; the single item concerning side effects was retained for separate analysis. Forced one-factor analysis showed that the two subscales can be combined to obtain a total score relating to overall treatment satisfaction. The GHerpTSQ has good internal reliability, clear structure with little overlap of subscales and evidence of good sensitivity to changes in treatment.     

Development of the Korean versions of WHO Quality of Life scale and WHOQOL-BREF

The purpose of this study was to develop the Korean version of World Health Organization Quality of Life study assessment instrument (WHOQOL) and WHOQOL-BREF, an abbreviated version of WHOQOL and to identify contributing factors in the quality of life of Koreans. The WHOQOL and WHOQOL-BREF were translated into colloquial Korean according to instructions of the WHOQOL study group. Then the Korean questionnaire was applied to 538 subjects, composed of 171 medical patients and 367 healthy subjects who volunteered to rate the scale. Finally, 486 subjects completed the rating. Collected data were analyzed statistically. The Korean version of WHOQOL and WHOQOL-BREF domain scores demonstrated good test–retest reliability, internal consistency, criterion validity, content validity and discriminant validity. The physical, psychological, social and environmental domains made a significant contribution to explaining the variance in the quality of life while the independence and spiritual domains made a lesser contribution. The domain scores produced by the WHOQOL-BREF correlated highly with the WHOQOL. The physical health domain contributed most in overall quality of life, while the social domain made the least contribution. These results suggest that the Korean version of WHOQOL and WHOQOL-BREF are valid and reliable in the assessment of quality of life and that physical domain is contributing most and social and spiritual factors are contributing least to the quality of life in Koreans.     

Comparative responsiveness and minimal change of the Knee Quality of Life 26-item (KQoL-26) questionnaire

Objectives

To assess the responsiveness of the KQoL-26 and demonstrate minimal change for this instrument in two different samples of patients with suspected internal derangement of the knee.

Methods

Data were collected from two surveys conducted alongside a clinical trial: the arthroscopy sample and the general practitioner (GP) sample. The effect size (ES) was used to assess responsiveness. Anchor-based minimal change included minimal clinical important difference (MCID) and receiver operator characteristic curves; standardized error of measurement and minimal detectable change (MDC) was employed for distribution-based approaches. The KQoL-26 results are compared with those for the Lysholm Knee Score, EQ-5D and SF-36.

Results

The arthroscopy sample consisted of 121 participants and the GP sample of 218 participants at baseline. The largest ES was found for the KQoL-26 emotional functioning scale in both samples. The results were in favour of the condition-specific instrument. The MCID for KQoL-26 physical functioning, activities limitations and emotional functioning scales were 3, 15 and 18, respectively, in the arthroscopy sample; they were 11, 16 and 24 in the GP sample. The MDC 95 % was estimated as 18, 28 and 34, and 15, 24 and 30 in each sample, respectively.

Conclusions

The KQoL-26 emotional functional scale was the most responsive of all scales. It is recommended that an instrument such as the KQoL-26 that includes emotional functioning should be included rather than the Lysholm in future clinical trials of patients with suspected internal derangement of the knee.     

The EORTC breast cancer-specific quality of life questionnaire (EORTC QLQ-BR23): Translation and validation study of the Iranian version

The objective of this study was to test the reliability and validity of the Iranian version of the European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). The English-language version of the questionnaire was translated into Persian (Iranian language) and its final form was approved by the EORTC Study Group on Quality of Life and then it was used in this study. The questionnaire was administered at two points in time to a consecutive sample of 168 newly diagnosed breast cancer patients and almost all of them (99%) found the questions easy to understand and acceptable. Cronbach's coefficient for multi-item scales (to test reliability) ranged from 0.63 to 0.95 at baseline and from 0.75 to 0.92 at follow-up administration of the questionnaire. Validity analysis was performed using known-groups' comparison analysis. The results showed that all functional and symptom scales discriminated between sub-groups of patients differing in clinical status as defined by their performance status and disease stage. In addition, all functional and symptoms scales detected change over time, as a function of changes in patients' performance status. In general, the findings of this study indicated that the Iranian version of the EORTC QLQ-BR23 is a reliable and valid supplementary measure of the quality of life in breast cancer patients and can be used in clinical trials and studies of outcome research in oncology.     

Injection Drug Use Quality of Life scale (IDUQOL): A validation study

Background  

Existing measures of injection drug users' quality of life have focused primarily on health and health-related factors. Clearly, however, quality of life among injection drug users is impacted by a range of unique cultural, socioeconomic, medical, and geographic factors that must also be considered in any measure. The Injection Drug User Quality of Life (IDUQOL) scale was designed to capture the unique and individual circumstances that determine quality of life among injection drug users. The overall purpose of the present study was to examine the validity of inferences made from the IDUQOL by examining the (a) dimensionality, (b) reliability of scores, (c) criterion-related validity evidence, and (d) both convergent and discriminant validity evidence.     

肿瘤坏死因子-Q基因启动子-850位多态性与强直性脊柱炎相关性研究（病人和13个家族调查）

目的探讨肿瘤坏死因子-α(TNF-α)的基因启动子-850位点多态性对强直性脊柱炎(AS)易感性和临床表现的影响。方法采用聚合酶链反应-限制性片段长度多态性(PCR-RFLP)方法,对33名AS患者、13个家庭的AS患者一级亲属39名以及187名正常对照者的TNF-α基因启动子-850位点进行基因分型,并分析基因型与疾病临床表现之间的关系。结果经病例-对照研究,TT基因型在AS组中的分布显著高于正常对照组(15.2%vs2.1%,P<0.01);T等位基因携带者在AS组与正常对照组间分布存在显著差异(75.8%vs21.4%,P<0.01);家庭调查也发现在AS一级亲属中T等位基因携带者显著高于正常对照组(64.1%vs21.4%,P<0.01);TX(CT TT)基因型与CC基因型的AS患者在病程、临床症状、B27阳性率方面无明显差异;CT分级方面,TX基因型AS患者的骶髂关节CT分级≥Ⅲ级者的比例较CC基因型AS患者高(60%vs37.5%,P>0.05);但在ESR、CRP方面,TX基因型AS患者较CC基因型AS患者明显升高(分别为80%vs37.5%;56%vs12.5%。P<0.05)。结论TNF-α基因启动子-850C→T的突变可能是AS发生的新易感基因。与AS的炎症严重程度也可能存在关联。     

Quality of life in Parkinson's disease: Greek translation and validation of the Parkinson's disease questionnaire (PDQ-39)

The Parkinson's disease questionnaire (PDQ-39) is a well-validated British scale for the assessment of health-related quality of life (HQoL) in Parkinson's disease (PD). The PDQ-39 has been translated into Greek and it was applied to 119 Greek PD patients. These patients were classified in stages according to the Hoehn and Yahr (HY) scale and their motor disability was assessed by means of the Unified Parkinson's disease rating scale (UPDRS) as well as the Schwab and England activities of daily living scale (ADL). The Beck depression inventory (BDI) was applied for the evaluation of depression. The translated version of PDQ-39, designated PDQ-39GrV, was validated as follows: (1) Cronbach's alpha coefficient and item-total Spearman's rank-order correlations were calculated in order to estimate the internal consistency of PDQ-39GrV scales. (2) Validity of the PDQ-39GrV was examined in terms of agreement with the clinical assessment parameters (stage, UPDRS. ADL and BDI scores). (3) Sixty one PD patients were re-evaluated 3-7 days later in order to check test-retest reliability. The results showed the following: (1) The PDQ-39GrV demonstrated very good internal consistency (alpha 0.71-0.94). Item-total correlations were statistically significant (r: 0.52-0.93). Test-retest measurements correlated significantly (p = 0.001). (2) Clinically obtained motor parameters correlated well with PDQ-39GrV scales influenced by physical aspects of the disease, while emotionally and socially influenced ones correlated with depression. Our findings indicate that PDQ-39 GrV is a reliable, easy to administer scale for the assessment of HQoL in Greek PD patients.     

Audit of Diabetes-Dependent Quality of Life (ADDQoL) [Chinese version for Singapore] questionnaire

Background

The Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire is an individualized instrument that measures the impact of diabetes mellitus on quality of life (QOL). With the worldwide increase in the number of Chinese people diagnosed with diabetes, we anticipated that a Chinese-language version of the ADDQoL would be urgently needed.

Objective

To evaluate the reliability and validity of the ADDQoL (Chinese version for Singapore) among Chinese-speaking Singaporeans with type 2 diabetes mellitus (T2DM).

Methods

Chinese versions of the ADDQoL, EuroQoL-Visual Analogue Scale (EQ-VAS), EQ-5D and SF-6D were administered to Chinese-speaking participants with T2DM (aged ≥21 years) at a tertiary acute-care hospital by convenience sampling. The ADDQoL was assessed for the following: internal consistency (Cronbach’s alpha); test-retest reliability (intraclass correlation coefficient [ICC]); factor structure; known-groups validity (insulin requiring vs non-insulin requiring, with vs without diabetes-related complications, overweight/obese vs not overweight/obese); and convergent and divergent validity (with EQ-VAS, EQ-5D and SF-6D). The usefulness of weighting and ‘not applicable’ (NA) options (key features of ADDQoL) were also evaluated.

Results

In 88 participants (58% male, mean [SD] age 56.6 [11.74] years), the mean (SD) ADDQoL average weighted impact (AWI) score was ?2.613 (1.899). Cronbach’s alpha was 0.941 and the ICC was 0.955 (95% CI 0.812, 0.990). In confirmatory factor analysis, the hypothesized one-factor solution was supported. ADDQoL AWI scores correlated strongly with ADDQoL diabetes-dependent global QOL scores (Spearman’s rank correlation coefficient [rs] = 0.5983) and weakly with generic measures (rs = ?0.028 for ADDQoL present global QOL scores, 0.310 for EQ-VAS, 0.164 for EQ-5D and 0.281 for SF-6D). Participants who required insulin, those with diabetes-related complications and those who were overweight/obese reported lower AWI scores, but the differences were not statistically significant. Importance scores of zero were assigned 1–28% of the time and the NA options were selected 3–49% of the time.

Conclusions

The ADDQoL is reliable and probably valid for assessing QOL among Chinese-speaking Singaporeans with T2DM, although known-groups validity warrants further investigation.