|Year : 2022 | Volume
| Issue : 3 | Page : 250-254
Translation, cross-cultural adaptation, and validation of fatigue severity scale into Bangla in patients with systemic lupus erythematosus
Imam Gazzali1, Md Abu Shahin1, Ariful Islam1, Iftekhar Hussain Bandhan1, Sumayia Minhaj1, Mohammad Moniruzzaman1, Sabrina Yesmin1, Minhaj Rahim Choudhury1, Syed Atiqul Haq1, Mohammad Mostafa Zaman2
1 Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
2 World Health Organization, Dhaka, Bangladesh
|Date of Submission||28-Sep-2021|
|Date of Acceptance||08-Dec-2021|
|Date of Web Publication||01-Jul-2022|
Dr. Iftekhar Hussain Bandhan
Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University, Shahbag, Dhaka 1000
Source of Support: None, Conflict of Interest: None
Objective: Fatigue is common in patients with systemic lupus erythematosus (SLE). Fatigue severity scale (FSS) is used to measure fatigue. This study was aimed to develop a culturally adapted Bangla version of the English FSS and to validate it.
Methods: English version of FSS was translated into Bangla and adapted in the local sociocultural context, following the recommendations of Beaton et al. One hundred and twenty SLE patients were assessed in the Rheumatology Department of Bangabandhu Sheikh Mujib Medical University. Content validity of the adapted Bangla version was evaluated by item-level content validity index (I-CVI) and scale-level content validity index (S-CVI). Correlation between FSS and health assessment questionnaire-disability index (HAQ-DI) and 12 item short form health survey (SF-12) was measured for the assessment of convergent validity. Internal consistency and test–retest reliability were also assessed.
Results: Our procedure had no problem with the content and language. I-CVI and S-CVI for each item was one. FSS showed strong positive correlation (>0.7) with HAQ-DI and strong negative correlation (>−0.7) with SF-12. The scale demonstrated excellent internal consistency (Cronbach's alpha = 0.93) and test–retest reliability (intraclass correlation coefficient = 0.93).
Conclusions: The adapted Bangla version of FSS is a reliable and valid instrument and can be recommended for the self-assessment of fatigue in SLE patients.
Keywords: Fatigue severity scale, questionnaire, systemic lupus erythematosus, validity
|How to cite this article:|
Gazzali I, Shahin MA, Islam A, Bandhan IH, Minhaj S, Moniruzzaman M, Yesmin S, Choudhury MR, Haq SA, Zaman MM. Translation, cross-cultural adaptation, and validation of fatigue severity scale into Bangla in patients with systemic lupus erythematosus. Indian J Rheumatol 2022;17:250-4
|How to cite this URL:|
Gazzali I, Shahin MA, Islam A, Bandhan IH, Minhaj S, Moniruzzaman M, Yesmin S, Choudhury MR, Haq SA, Zaman MM. Translation, cross-cultural adaptation, and validation of fatigue severity scale into Bangla in patients with systemic lupus erythematosus. Indian J Rheumatol [serial online] 2022 [cited 2022 Oct 4];17:250-4. Available from: https://www.indianjrheumatol.com/text.asp?2022/17/3/250/349453
| Introduction|| |
Fatigue is a common symptom in several diseases. It is used to describe difficulty or inability to initiate activity, reduced capacity to maintain activity or difficulty with concentration, memory, and emotional stability. Chaudhuri and Behan defined fatigue as a subjective experience that includes rapid inanition, persistent lack of energy, exhaustion, physical and mental tiredness, and apathy.
Fatigue has a broad range of etiologies including acute and chronic medical disorders, psychological conditions, medication toxicities, and substance abuse. Twenty-one to 33% of patients seeking attention in primary care settings describe fatigue as an important problem, if not always the chief complaint. The prevalence rates of fatigue in population-based surveys in Britain and the United States varied between 6.0% and 7.5%. Fatigue is reported more commonly in women than men.
Systemic lupus erythematosus (SLE) is a chronic autoimmune systemic disease with unknown causes characterized by a wide variety of clinical manifestations and unpredictable course with flares and remissions. The prevalence of fatigue among SLE patients is 67%–90%. In SLE patients, chronic debilitating fatigue may impair the quality of life, increasing the risk of work disability, and increased health-care costs.,,
At least thirty different fatigue measurement scales have been described in the literatures. Some of the commonly used scales are Fatigue Severity Scale (FSS), Chalder Fatigue Scale, Piper Fatigue Scale, Fatigue Self-efficacy Scale, short form-36 vitality subscale, multidimensional assessment of fatigue, visual analog scale (VAS), fatigue assessment instrument FAI, VAS-fatigue, Sjogren's-Based Psychometric Instrument, and single question for fatigue.,,,,,,,,,, FSS was the most commonly used and recommended scale to measure fatigue in SLE patients. This study aimed to develop a culturally adapted Bangla version of the English FSS and to test its reliability and validity.
| Methods|| |
This study was conducted in the Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh. The study period was from July 2018 to August 2019.
All patients of SLE attending the outpatient department of rheumatology, BSMMU were approached for enrollment after checking the inclusion and exclusion criteria. The inclusion criteria were SLE, diagnosed according to revised ACR classification criteria 1997, for >1-year duration on remission (Safety of Estrogens in Lupus Erythematosus: National Assessment Version of the SLE disease activity index <3) for more than 3 months, age ≥18 years, and both genders. Participants were excluded from the study if they had major psychiatric diseases, has taken any anxiolytics, antidepressants, opioids, antihistamines, and relapse of SLE in the previous 3 months. Written informed consent was obtained from all participants.
Original English fatigue severity scale
The FSS is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in a variety of medical disorders. It was originally developed for people with multiple sclerosis (MS) and SLE. Answers are scored on a seven-point scale where 1 = strongly disagree and 7 = strongly agree. The minimum possible score is 9 and the highest is 63. The higher the score, the more severe the fatigue and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer.
The study was conducted in two phases. Phase I consisted of translation and cross-cultural adaptation of the English version of FSS into Bangla according to guidelines of Beaton et al., 2000. Testing of the validity of the Bangla version was carried out in the phase II.
Phase I: Translation and cross-cultural adaptation of the fatigue severity scale questionnaire
Translation and cross-cultural adaptation were accomplished in following six stages:
Stage I: Forward translation
Two translators whose mother tongue was Bangla did the forward translations. One of the translators was aware of the concepts being examined in the questionnaire and other translator was neither aware nor informed of them. The first and second translations were marked as T1 and T2, respectively. One of the translators was investigator himself (IG). Each of translators submitted a written report to the expert committee.
Stage II: Synthesis of Bangla version (Ts)
The two translators and a recording observer (a third unbiased person was added to the team) sat together to synthesize the results of translations. From initial T1 and T2 and with some changes depending on local customs, habits, usage of words, etc., a synthesized Bangla version Ts was produced.
Stage III: Back translation
Ts version of the questionnaire was back translated into English by two translators (BT1 and BT2) with good command in English language totally blind of original version. They were without medical background and neither aware nor informed of the concepts.
Stage IV: Expert committee review
This committee consisted of one methodologist who was a teacher in the department of public health and informatics of BSMMU, one rheumatologist, one language professional, four translators (forward and back translators), and the recording observer. Materials at disposal of the committee were the English FSS questionnaire, two forward translations of the English FSS questionnaire (T1 and T2), synthesized version (Ts), two backward translations (BT1 and BT2) of the synthesized version (Ts), all corresponding reports.
The committee compared all the translations and English FSS. They verified the semantic, idiomatic, experiential, and conceptual equivalence among all English and Bangla versions. Consensus was reached on each item, and preliminary Bangla questionnaire was developed.
Stage V: Test of the preliminary Bangla version
There is a recommendation for questionnaire that it should be understood by a 12-year-old boy/girl. Hence, the preliminary Bangla version of FSS questionnaire was administered to 20 school-going children aged 12 years. A total of 10 students (all girls) were interviewed from Dhaka city, the investigator visited at Mirpur Girls' Ideal Laboratory Institute, Dhaka. He talked with the head of the institute and explained the study procedure. The head of the institute randomly selected the students. Similarly, a total of ten students (five boys and five5 girls) were interviewed at Gopaldighi High School, Singhatia village, district-Tangail, Bangladesh. There were nine questions in the questionnaire and were presented to the subjects. They were asked to describe what they understood and were recorded by recording observer. From the responses of the 12-year-old children, necessary modifications were done in the pre-final Bangla version and were tested in a sample of forty adult SLE patients. These patients were randomly selected according to inclusion and exclusion criteria from SLE clinic, rheumatology outpatient department, BSMMU, Shahbag, Dhaka. Each of the SLE patients was interviewed about what they understood, and the items were modified according to their responses.
Stage VI: Submission and appraisal of all written reports
All the written reports were submitted to guide and co-guide, and they verified whether the recommended stages were followed and whether a reasonable translation was achieved. After checking understandability and pretesting, the best understood (100%) and the best-chosen items by the participants were chosen from the prefinal version to constitute the adapted version. Thus, the prefinal version of the questionnaire was prepared.
Phase II: Assessment of the psychometric properties of the prefinal Bangla version of fatigue severity scale
Testing of the validity and reliability of the prefinal Bangla version of the questionnaire was carried out in the second phase. Content validity was assessed by the item-level content validity index (I-CVI) and the scale-level content validity index (S-CVI). Content validity indices were assessed by four rheumatologists of BSMMU. Each expert rated each item either 1 (not relevant), 2 (somewhat relevant), 3 (quite relevant), or 4 (highly relevant). Subsequently, the Bangla version of the FSS with appropriate content validity was served in 130 adult SLE patients.
The correlation between FSS on one hand and health assessment questionnaire-disability index (HAQ-DI) and SF-12 on the other were measured with the same group of SLE patients for testing the convergent validity. All the correlations were assessed by Spearman's rank correlation coefficient. Internal consistency and test–retest reliability were assessed as methods for testing reliability. Internal consistency was measured by Cronbach's α. For test–retest reliability, the Bangla version of the FSS was reapplied to all participants 7 days after the first interview. The test–retest reliability of the FSS total score and item-item scores were measured by intraclass correlation coefficient (ICC, [r]). The ICC (r) and its 95% confidence interval were calculated using the Statistical Package for the Social Sciences (SPSS) version 25 (IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp).
| Results|| |
Phase I: Translation and validation
The forward and back translation of the FSS questionnaire in the phase-1 was carried out without major difficulties. Minor discrepancies were solved during the expert committee review. The items best understood (100%) and the best-chosen by the 12-year-old children and 40 patients during the probing were selected for the prefinal adapted version. There was no requirement of modification of any item for cultural adaption.
Phase II: Psychometric properties of the adapted Bangla version of the fatigue severity scale
In phase-2, 130 patients with SLE meeting the inclusion criteria were enrolled. Ten respondents could not be followed-up for retest. Mean age of them was 30.56 (±8.768 standard deviation) years. Majority of them (36.7%) occupied the age group of 26–35 years; most of them were female (96.7%) and having a level of education up to primary (44.9%), 70.8% and 11.7% were housewives and student, respectively. Most (56.7%) of them lived in urban area. Content validity of the adapted version was assessed by four rheumatologists. (I-CVI) was found 1 for each item, and S-CVI was therefore 1 by the averaging calculation method. Convergent validity, the Spearman's correlation coefficients describing the extent of the correlation between the FSS scores, and HAQ-DI was 0.74, P < 0.001, between FSS scores, and SF_12_MCS was −0.76, P < 0.001, SF_12_PCS was −0.72, P < 0.001. These demonstrate a strong positive correlation between the FSS and the HAQ-DI and strong negative correlation between the FSS and the SF-12. The internal consistency (Cronbach's alpha) of Bangla version of the FSS total score was 0.93, P < 0.001. Item-Item statistics of the Bangla version of the FSS were shown in [Table 1]. Ten participants dropped out at this stage and 120 could be included in the test–retest reliability assessment. (ICC, [r]) of FSS total score was found 0.93, P < 0.001. (ICC, [r]) of item-item was found between 0.81 and 0.86 [Table 2]. The final bangla version of FSS is available.
|Table 1: Item-item statistics of the Bangla version of the Fatigue Severity Scale|
Click here to view
|Table 2: Test-retest reliability by intraclass correlation co-efficient of individual items of Bangla version of the questionnaire|
Click here to view
| Discussion|| |
Various scales are used in clinical research designed to elicit initial information about a disease, monitor the possible changes of symptoms, and evaluate the efficacy of the treatment process. The FSS has been used in different populations and clinical settings such as SLE, MS, fibromyalgia, Lyme Borreliosis, postpolio, amyotrophic lateral sclerosis, cancer, brain injury, Parkinson's disease, insomnia, sleep apnea, chronic neck pain, stroke, and HIV infected patients. Translation, cultural adaptation, and validation of the FSS questionnaire have been performed into many other languages such as Arabic, Turkish, Portuguese, Chinese, Swedish, Danish, Indonesian, and Finnish, but till now, it has not been translated and validated into Bangla language.,,,,,,,
This study aimed to carry out the translation, cross-cultural adaptation of the FSS for Bangla speaking population, and secondarily, to determine the psychometric properties of this version in SLE patients. Translation and cross-cultural adaptation of the FSS questionnaire were done according to the guidelines and no appreciable difficulties were encountered.
The prefinal version of the scale was found to have excellent content validity in the form of I-CVI (=1), S-CVI (=1). Adapted Bangla version achieved a good readability. As in the Danish study, the correlation between the FSS and HAQ-DI, SF-12 was strong representing an acceptable construct validity. There was good internal consistency of the adapted Bangla version of the FSS, which was similar in magnitude to other studies.,, The high internal consistency had showed the homogeneity of the items in the FSS. It also had excellent test–retest reliability consistent with other studies.,
| Conclusions|| |
Cross-cultural adaptation was performed following standard recommendations. Based on statistical calculations, an optimum number of patients were enrolled in the second phase of the study. It was the first study to validate a version of the FSS psychometrically in Bangladeshi patients with SLE. The adapted Bangla version demonstrated excellent content and good construct validity as well as good internal consistency and test–retest reliability. The final bangla version of FSS could be a useful instrument for Bangladeshi patients both in clinical practice and for research.
This study was approved by the institutional review board, BSMMU, Dhaka, Bangladesh. The IRB clearance ID no was BSMMU/2018/11358.
Informed consent was obtained from all participating subjects.
We acknowledge Dr. Shamim Ahmed and Professor Md. Nazrul Islam, Department of Rheumatology, BSMMU, for their contributions to the conceptualization and design of the study. We also acknowledge Dr. Jesmin Buli, Assisstant professor, Department of Bangla, Mirpur Girls' Ideal Laboratory Institute, Dhaka, for her kind co-operation throughout the translation process.
Financial support and sponsorship
This study was funded by BSMMU research grant.
Conflicts of interest
There are no conflicts of interest.
| References|| |
Chaudhuri A, Behan PO. Fatigue in neurological disorders. Lancet 2004;363:978-88.
Bates DW, Schmitt W, Buchwald D, Ware NC, Lee J, Thoyer E, et al.
Prevalence of fatigue and chronic fatigue syndrome in a primary care practice. Arch Intern Med 1993;153:2759-65.
Lawrie SM, Manders DN, Geddes JR, Pelosi AJ. A population-based incidence study of chronic fatigue. Psychol Med 1997;27:343-53.
Fuhrer R, Wessely S. The epidemiology of fatigue and depression: A French primary-care study. Psychol Med 1995;25:895-905.
Gurevitz SL, Snyder JA, Wessel EK, Frey J, Williamson BA. Systemic lupus erythematosus: A review of the disease and treatment options. Consult Pharm 2013;28:110-21.
Cleanthous S, Tyagi M, Isenberg DA, Newman SP. What do we know about self-reported fatigue in systemic lupus erythematosus? Lupus 2012;21:465-76.
Da Costa D, Dritsa M, Bernatsky S, Pineau C, Ménard HA, Dasgupta K, et al.
Dimensions of fatigue in systemic lupus erythematosus: Relationship to disease status and behavioral and psychosocial factors. J Rheumatol 2006;33:1282-8.
Al Dhanhani AM, Gignac MA, Su J, Fortin PR. Work disability in systemic lupus erythematosus. Arthritis Rheum 2009;61:378-85.
Panopalis P, Yazdany J, Gillis JZ, Julian L, Trupin L, Hersh AO, et al.
Health care costs and costs associated with changes in work productivity among persons with systemic lupus erythematosus. Arthritis Rheum 2008;59:1788-95.
Ahn GE, Ramsey-Goldman R. Fatigue in systemic lupus erythematosus. Int J Clin Rheumatol 2012;7:217-27.
Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol 1989;46:1121-3.
Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, et al.
Development of a fatigue scale. J Psychosom Res 1993;37:147-53.
Piper BF, Dibble SL, Dodd MJ, Weiss MC, Slaughter RE, Paul SM. The revised Piper Fatigue Scale: Psychometric evaluation in women with breast cancer. Oncol Nurs Forum 1998;25:677-84.
Austin JS, Maisiak RS, Macrina DM, Heck LW. Health outcome improvements in patients with systemic lupus erythematosus using two telephone counseling interventions. Arthritis Care Res 1996;9:391-9.
Ware JE, Kosinski M, Keller SD. SF-36 Health Survey: Manual and Interpretation Guide. MA, USA: The Health Institute, New England Medical Center; 1983.
Tack BB. Fatigue in rheumatoid arthritis. Conditions, strategies, and consequences. Arthritis Care Res 1990;3:65-70.
White PD, Grover SA, Kangro HO, Thomas JM, Amess J, Clare AW. The validity and reliability of the fatigue syndrome that follows glandular fever. Psychol Med 1995;25:917-24.
Schwartz JE, Jandorf L, Krupp LB. The measurement of fatigue: A new instrument. J Psychosom Res 1993;37:753-62.
Belza BL, Henke CJ, Yelin EH, Epstein WV, Gilliss CL. Correlates of fatigue in older adults with rheumatoid arthritis. Nurs Res 1993;42:93-9.
Bowman SJ, Booth DA, Platts RG; UK Sjögren's Interest Group. Measurement of fatigue and discomfort in primary Sjogren's syndrome using a new questionnaire tool. Rheumatology (Oxford) 2004;43:758-64.
Taylor J, Skan J, Erb N, Carruthers D, Bowman S, Gordon C, et al.
Lupus patients with fatigue-is there a link with fibromyalgia syndrome? Rheumatology (Oxford) 2000;39:620-3.
Ad Hoc Committee on Systemic Lupus Erythematosus Response Criteria for Fatigue. Measurement of fatigue in systemic lupus erythematosus: A systematic review. Arthritis Rheum 2007;57:1348-57.
Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997;40:1725.
Mikdashi J, Nived O. Measuring disease activity in adults with systemic lupus erythematosus: The challenges of administrative burden and responsiveness to patient concerns in clinical research. Arthritis Res Ther 2015;17:183.
Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976) 2000;25:3186-91.
Polit DF, Beck CT. The content validity index: A.0.re you sure you know what's being reported? Critique and recommendations. Res Nurs Health 2006;29:489-97.
Moser AD, Knaut LA, Zotz TG, Scharan KO. Validity and reliability of the Portuguese version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form. Rev Bras Reumatol 2012;52:348-56.
Al-Sobayel HI, Al-Hugail HA, AlSaif RM, Albawardi NM, Alnahdi AH, Daif AM, et al.
Validation of an Arabic version of Fatigue Severity Scale. Saudi Med J 2016;37:73-8.
Gencay-Can A, Can SS. Validation of the Turkish version of the fatigue severity scale in patients with fibromyalgia. Rheumatol Int 2012;32:27-31.
Laranjeira CA. Translation and adaptation of the fatigue severity scale for use in Portugal. Appl Nurs Res 2012;25:212-7.
Feng C, He Q, Wu Y, Hu X, Wu J, He X, et al.
Psychometric properties of fatigue severity scale in Chinese systemic lupus erythematosus patients. Health Qual Life Outcomes 2019;17:71.
Mattsson M, Möller B, Lundberg Ie, Gard G, Boström C. Reliability and validity of the Fatigue Severity Scale in Swedish for patients with systemic lupus erythematosus. Scand J Rheumatol 2008;37:269-77.
Lorentzen K, Danielsen MA, Kay SD, Voss A. Validation of the Fatigue Severity Scale in Danish patients with systemic lupus erythematosus. Dan Med J 2014;61:A4808.
Rifa'i A, Kalim H, Handono K, Wahono CS. Validity and reliability fatigue severity scale in patients with Systemic Lupus Erythematosus (SLE) in Indonesia. Ina J Rheum 2018;8:4-6.
Rosti-Otajärvi E, Hämäläinen P, Wiksten A, Hakkarainen T, Ruutiainen J. Validity and reliability of the Fatigue Severity Scale in Finnish multiple sclerosis patients. Brain Behav 2017;7:e00743.
[Table 1], [Table 2]