Cultural Adaptation and Validation of the Chinese Version of the Systemic Lupus Erythematosus Activity Questionnaire in a Cohort of Chinese Patients with Lupus

Objectives: To examine the responsiveness, reliability, and validity of Chinese version of Systemic Lupus Erythematosus Questionnaire (SLAQ). Methods: A cross-sectional observational study was designed for this research. The principal attributes evaluated were linguistic and cultural adaption, reliability, and validity. Standardized response means and acceptability were calculated to estimate the responsiveness of the SLAQ. Cronbach’s alpha was used to evaluate its reliability. The Spearman correlation coecient was used to assess the criterion validity by calculating the association with measurement of other lupus disease activity. Results The response rate for the pilot study was 99.9%. The mean time to complete the questionnaire was 6.7±2.8 min. The Chinese version of SLAQ had good reliability, with a Cronbach’s alpha of 0.857. Cronbach’s alpha for the test-retest reliability was 0.878. For validity, the SLAQ was correlated with SLAM, SLEDAI-2000 and SLEDAI-no lab. The correlation was good at 0.832, 0.506 and 0.668 respectively. and validity in and laboratory


Introduction
Assessing disease activities in patients with lupus is an important part of their disease management.
Lupus ares can contribute to organ damage and even death [1].Clinical symptoms and laboratory results are typically collected by physicians to evaluate disease activity using assessment tools.

BACKGROUND
The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a commonly used scale for evaluating disease activity.The SLEDAI is a cumulative index used by physicians and other professional healthcare providers across 21 different disease descriptors.Medical history, physical examination, and laboratory data must be collected to be scored in hospitals, which is time-consuming and costly.Some clinical features, such as fatigue, fever, and weight loss, are common and disabling symptoms affecting lupus patients.These symptoms, causing decreased functioning capacity, negatively in uence healthrelated quality of life [2].
The Systemic Lupus Erythematosus Activity Questionnaire (SLAQ) is a patient-reported instrument based on patients' subjective complaints in the absence of laboratory results for assessing disease activity.The SLAQ was developed based on the Systemic Lupus Activity Measure (SLAM) as a more economical way of following and tracking large groups of SLE patients who may be at a distance from a center in epidemiologic studies.This scale has three parts, including a single patient assessment (PGA) regarding the presence and severity of lupus ares, a list of 24 questions related to lupus symptoms (symptom score), and a single question regarding the numerical rating scale (NRS) for global disease activity.
Scoring on the PGA ranged from 0 to 3 and asked about the presence and severity of lupus activity during the past three months.There are 24 questions related to different lupus symptoms, including constitutional, mucocutaneous, articular, respiratory, gastrointestinal, neuropsychiatric, and gastrointestinal manifestations.Among these 24 questions, there was no rating severity for symptoms, and positive answers were accounted for.The NRS is a single numerical scale for patients' global disease activity during the previous three months.The NRS score ranges from 0 to 10, indicating a scale of no activity to high activity.
The prevalence range of lupus is 30-60 per 100,000 persons.The 10-year survival rate was over 70%.The SLAQ is the only patient reported instrument for assessing patients' disease activities without laboratory results.However, there is no Chinese version for SLE patient in China.
The purpose of this study is to translate the SLAQ into Chinese and verify its reliability and validity in a large cohort.

Study Design
A cross-sectional observational study was designed for this research.The principal attributes evaluated were linguistic and cultural adaption, reliability, and validity.

Setting and sample
The study population included patients with systemic lupus erythematosus (SLE) who were18 years or older and were seen by the rheumatology department of a teaching hospital in Shanghai, China.All eligible subjects had SLE (according to the revised American College of Rheumatology [ACR] criteria for SLE) [3] and provided informed consent to participate in this study.Dementia, neurological de cit, or linguistic barriers that could signi cantly compromise the understanding of the questionnaire were included in the exclusion criteria [4].

Variables
All participants were provided with SLAQ, SLEDAI, SLAM, and a demographic questionnaire to collect data on the following variables: sex, age, disease duration, educational level, marital status, and fertility status.SLEDAI was administered to demonstrate criterion validity and was assessed by rheumatologists who were blinded to the SLAQ results. 1) the SLAQ score contains 24 symptoms, and patients were asked to choose a response from among mild, moderate, severe, and no symptoms.All items were weighted and aggregated based on Karlson et al [5] and ranged from 0 to 44. 2) PGA is related to the presence and severity of lupus activity during the past three months (range 0-3).3) The NRS is a numerical rating scale for global disease activity (range 0-10).

Translation process
The translation and cultural adaptation process followed international guidelines.
1. Two native Chinese speakers each translated the original scale into Chinese and obtained two versions of the scale; the two translations were then reconciled into a single Chinese version.The two translators are bilingual and bicultural professional translators.
2. Another experienced English-speaking translator who was blinded to this study and to the English version of the original scale translated the Chinese version back into English.The English-speaking translator is a bilingual and bicultural professional healthcare provider.
3. A manager approved a harmonized translation through discussion with the three translators.conducted.Moreover, in the face-to-face interviews, the participants were encouraged to verbalize anything they thought about.The retrospective probing was held to ask the participants further questions based on their feedback.Both the think-aloud and retrospective probing processes can facilitate better observation of any di culties in understanding, recalling, and answering.Finally, an expert review committee including six Chinese experts, who are rheumatology doctors and advanced practice nurses, reviewed the nal Chinese version of the SLAQ.

Validation
Each patient provided written informed consent.

Inclusion criterion
Rheumatology ward inpatients enrolled in the study met the diagnosis of the 1997 American College of Rheumatology (ACR) criteria for lupus between June and August 2019 in a teaching hospital.All patients were 18 years or older.

Exclusion criteria
The patients had no neurological de cits, dementia, or linguistic barriers.

Statistical analysis
For the descriptive analysis, the categorical variables were reported as proportions, and continuous values were expressed as mean and standard deviation as appropriate.
Cronbach's alpha was used to test the internal consistency of the SLAQ.A Cronbach's alpha of > 0.7 was considered internally consistent and reliable at the group level.
Criterion validity was tested using the validated activity index (SLEDAI-2000 and SLAM) scored by a physician who was blinded to the SLAQ results.Spearman's rank correlations were used, and the level of statistical signi cance was de ned as 5% (p<0.05).
There were 35 patients in a subgroup testing the reliability and agreement for the test-retest validity assessment, which was two weeks after the rst assessment.
For the test-retest validity assessment, 35 patients from the study were enrolled in a subgroup and administered the questionnaire again two weeks after their rst questionnaire was completed.

Ethics
The study was reviewed and approved by the institutional review board (IRB).All the participants signed an informed consent approved by the IRB.

Internal consistency
The SLAQ demonstrated excellent internal consistency with a Cronbach's alpha of 0.857.The Cronbach's alpha of the SLAQ symptom items was 0.802.The test-retest reliabilities of the SLAQ and SLAQ symptoms were 0.878 and 0.799, respectively, which also indicated good reliability.

Criterion validation
The correlation coe cients among SLAM, SLEDAI, SLEDAI-no lab, SLAQ, PGA, and NRS are shown in Table 2.The correlations were good to moderate between SLAM(ρ=0.832),which was assessed by a physician, and SLAQ, which were self-assessed by patients.The correlation between SLAQ and SLEDAI and SLEDAI-nolab was good, at 0.506 and 0.668, respectively.

Discussion
This study translated and validated the SLAQ questionnaire into Chinese, providing a useful tool for the self-assessment and evaluation of the symptoms and disease activity of lupus patients without the use of laboratory results.We report moderate to good correlation between SLAQ, SLAM, and SLEDAI, which included patients' and physicians' assessments of disease activity.The feasibility, reliability, and validity of the Chinese version of the SLAQ were evaluated in this study.
Following the process of translation and transcultural adaptation, the nal Chinese version of the SLAQ was tested in a sample of 245 patients with lupus.Its feasibility was good in routine clinical practice.All patients completed the questionnaire in less than ten minutes, with a mean time of less than seven minutes.All patients completed the questionnaire before visiting their physician.Every patient declared their understanding of the scope and content comprehension of the questionnaire.

4 .
Comparing the original English version with the harmonized translation, a professional multidisciplinary committee that formed the research team approved the Chinese version, and all translators reviewed and nalized the translation.Cognitive debrie ng and pilot study Following the recommended guidelines, the Chinese version of the SLAQ was evaluated in a pilot study with 35 SLE patients with different demographic characteristics (age, gender, education level, and place of residence), which indicated a need for minor linguistic corrections.Cognitive debrie ng interviews were of the pilot study was 99.9%, indicating a good level of acceptance of the questionnaire.The mean time to complete the questionnaire was 6.7±2.8 min.All patients understood the scope of the Chinese version of the SLAQ with no comprehension problems.