Content validity of the ASQoL for use in a non-radiographic axial spondyloarthritis population: a qualitative study.

PURPOSE: The ankylosing spondylitis quality of life (ASQoL) instrument is widely used to assess health-related quality of life in patients with ankylosing spondylitis (AS). We assessed the relevance of the ASQoL items in patients with non-radiographic axial spondyloarthritis (nr-axSpA), a distinct subgroup within the axSpA disease spectrum. METHODS: This observational, cross-sectional, qualitative interview study recruited patients from clinic settings. Interviews from patients with axSpA who participated in a prior qualitative study were also used. Patients initially underwent a concept elicitation interview using open-ended questions to evaluate relevance of the concepts measured by the ASQoL. They then completed the ASQoL and underwent a cognitive interview to assess their understanding of the items, instructions and response options. Transcripts from patients who participated in the previous qualitative study (who did not complete the ASQoL or undergo cognitive interview) were evaluated to identify expressions of the concepts in the ASQoL. RESULTS: A total of 18 patients with nr-axSpA participated. The concept elicitation interview findings supported the relevance of the ASQoL items. Cognitive interviews determined that the ASQoL was easily understood; the 13 new patients chose a response for each item that matched their experience with nr-axSpA. Transcripts for the five previously interviewed patients confirmed the concepts presented in the ASQoL items were relevant and important to their experience of living with nr-axSpA. CONCLUSIONS: Our results represent an important first step in confirming the relevance of the concepts in the ASQoL to patients with nr-axSpA, supporting quantitative assessment of ASQoL validity in this population.

Validation of the Korean Ankylosing Spondylitis Quality of Life Questionnaire.

Background: Measuring accurate and reliable scores of quality of life in patients with ankylosing spondylitis (AS) is important in both decision-making and treatment planning for the disease. Questionnaire, The ankylosing spondylitis quality of life (ASQoL), is one of the representative tools for assessing how seriously AS patients view their disease severity, activity, as well as their overall health. To make these types of questionnaires readable and understandable, local language translation of surveys should be required. A Korean version of the ASQoL questionnaire has accordingly been developed. This study assessed the Korean version of the ASQoL survey to evaluate the reliability and validity of it. Methods: Translation and reverse translation of the English ASQoL survey were conducted. A total of 120 consecutive AS patients received a mail including the Korean-translated 36-Item Short Form Survey (SF-36), the ASQoL survey, and the visual analog scale (pain). The coefficient of intraclass correlation and Cronbach's alpha were computed, and factor analysis, as well as reliability assessments utilizing the kappa agreement statistics for each item, was undertaken. By analyzing the responses to SF-36 and ASQoL questionnaire utilizing Pearson's correlation coefficient, construct validity was calculated. Results: Factor analysis was performed regarding pain, physical function, and mental function. The kappa statistic of agreement was larger than 0.6 for all items. The ASQoL questionnaire had adequate test and re-test reliability (0.814). Furthermore, Cronbach'sα, the internal consistency, was very good (0.877). The Korean-translated ASQoL questionnaire demonstrated a significantly strong correlation between the single domain and total SF-36 scores. Conclusions: The Korean version of the ASQoL questionnaire showed acceptable properties of measurement and successful translation. Thus, it can be said that the questionnaire is appropriate for evaluating the outcomes of Korean patients with AS.

Reliability and validity analysis of the Chinese version of Evaluation of Ankylosing Spondylitis Quality of Life (EASi-QoL).

OBJECTIVE: We aimed to convert the English version of the Evaluation of Ankylosing Spondylitis Quality of life (EASi-QoL) into a Chinese version, and to test the reliability and validity of the Chinese version of EASi-QoL. METHODS: The EASi-QoL was translated into Chinese. A total of 127 patients with ankylosing spondylitis (AS) were evaluated using the Chinese version of EASi-QoL to test its validity and reliability. Internal and test-retest reliability was assessed. In addition, correlation and exploratory factor analyses evaluating the structural, convergent, and criterion-related validities of this measure were performed. RESULTS: The total Cronbach's α coefficient of the Chinese version of EASi-QoL was 0.911. The Kaiser-Meyer-Olkin value of the scale in this study was 0.917, and the Bartlett's test value was 2403.499. The convergent validity of the related domains was analyzed using confirmatory factor analysis; and the average variance extracted values corresponding to the four dimensions were all > 0.5, and the composite reliability values were all > 0.7. Discriminative validity analysis showed that the correlation between the four domains of EASi-QoL and their related domains of the depression/anxiety screening scale and the Medical Outcomes study Short-Form 36 were moderate to high. CONCLUSION: The Chinese version of EASi-QoL has high reliability and validity, and can reflect the impact of AS on the quality of life. Key Points • The Chinese version of EASi-QoL can accurately measure the impact of AS on the quality of life from the perspective of a patient. It is applicable to the evaluation of AS patients in China • The Chinese version of EASi-QoL is a scale with good reliability and validity.

A study protocol for a randomised controlled trial on the efficacy of yoga as an adjuvant therapy for patients with Ankylosing spondylitis amidst COVID-19 pandemic.

Background: Amidst the adversities of the COVID-19 pandemic, the health care system has seen a new paradigm shift towards e-health or telehealth services. In the advent of catering to the geometrically increasing health care needs of the patients suffering from various chronic health conditions when in social isolation, the need for such shifts is paramount. Patients with Ankylosing spondylitis using immunosuppressants with variable degrees of disabilities are at higher risk from this isolated status. This study aims to assess the efficacy of e-Yoga as a treatment option for these patients. Methods: The proposed study is a single-center, parallel-group prospective randomized, open-blinded end-point trial. Patients aged between 30 and 50 years will be recruited from the members of Antardhwani: A society of ankylosing spondylitis based in Ahmedabad, Gujarat. Yoga experts will administer a scientifically developed and validated Yoga module via e-Yoga modalities. A total of 135 patients will be recruited and randomly allocated to Yoga and control groups. Data will be recorded at baseline and three months on disease activity, degree of functional limitations in patients, quality of life, inflammatory biomarkers, depression, and anxiety using Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), AS Quality of Life index (ASQOL), C reactive protein (CRP), Erythrocyte sedimentation rate (ESR), Physical health questionnaire-4 (PHQ-4), respectively. Discussion: The study will report the efficacy of e-Yoga in catering to the physical and mental insufficiencies of inpatients with Ankylosing spondylitis amidst COVID-19 pandemic. The study is prospectively registered in the Clinical Trial Registry of India (CTRI/2020/08/027215).

Alexithymia in ankylosing spondylitis.

OBJECTIVES: This study aims to determine the effect of ankylosing spondylitis (AS) on alexithymia. PATIENTS AND METHODS: In this study, a total of 55 AS patients (30 males, 25 females; mean age: 40±8 years; range, 21 to 57 years) who were under follow-up and 55 age- and sex-matched healthy volunteers (31 males, 24 females; mean age: 38.9±8.5 years; range, 21 to 53 years) were included between March 2016 and August 2016. Toronto Alexithymia Scale (TAS), and Beck Depression Inventory (BDI) were performed to assess both patient and control groups. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), and Ankylosing Spondylitis Quality of Life (ASQoL) were performed to assess AS patients. RESULTS: The mean diagnosis time in the patient group was 5.18±4.32 (range, 1 to 18) years. Compared to the control group, depression scores were higher in the patient group and the alexithymic characteristics were significantly higher in the patient group (p<0.05). There was a positive correlation between complaint duration and BASMI, BASFI, and ASQoL scores (p<0.01). In our study, alexithymia rate was significantly higher in women (p<0.05). CONCLUSION: As in all inflammatory chronic diseases, depression and anxiety are commonly seen in AS patients. Alexithymia of these patients should be considered carefully.

It is time for an organised, scientific approach to the application of patient-reported outcome measures in clinical studies and trials.

Too often, clinicians and researchers assume that patient-reported outcome measures (PROMs) are simply designed, can be changed to suit specific circumstances and should be freely available for use without seeking permission. If a version is not easily available, they believe they can produce a new translation without relevant experience or expertise. Copyright issues are inconvenient and commonly ignored, despite some journals requesting confirmation from authors that permission had been granted for use of copyrighted materials. When informed that authors of an article did not have such permission, the response from an editor was that nothing could be done as he had to rely on the word of the authors.In fact, high quality PROMs are carefully designed, developed for new cultures by means of proven standardised methodologies, carefully re-validated in the new culture and then administered by a responsible organisation to ensure that they are used appropriately in studies. If such care has not been taken, questions should be raised about the quality of the measure and the information it generates.Several problems have arisen with the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL). This is probably because it is recognised as the most appropriate measure of quality of life for people with Ankylosing Spondylitis and has been widely used in international clinical trials and studies. Fifty-seven official language adaptations of the questionnaire have been produced. Unfortunately, as a result of unauthorised adaptation and use, questions are raised about the validity of several publications that have used the ASQoL.