Short Health Scale: a Valid and Reliable Quality of Life Scale for Chinese Patients With Inammatory Bowel Disease

Background: The aim of our study was to translate and validate the Chinese version of the Short Health Scale (SHS), a disease-specic quality of life (QoL) scale for the patients with inammatory bowel disease (IBD). Methods: The SHS was translated and validated according to the standard process: a translation and back-translation procedure, culture adaptation and a validation study. Patients with IBD were enrolled, and their QoL were assessed using the SHS and the short inammatory bowel disease questionnaire (SIBDQ). Reliability (internal consistency reliability, split-half reliability and test-retest reliability) and validity (content validity, construct validity, criterion validity and discriminant validity) analysis were performed to evaluate the psychometric characteristics of the SHS. Results: A total of 95 patients with IBD (62 ulcerative colitis and 33 Crohn’s disease) completed the Chinese version of the SHS, and 40 patients completed the SHS within 1-4 weeks once again. Cronbach's alpha value of the SHS was 0.91, and its split-half coecient was 0.83. Intraclass correlation coecients of four items ranged from 0.55 to 0.75. All four items of the SHS were signicantly associated with the corresponding domains of the SIBDQ, with correlation coecients ranging from -0.47 to -0.63 (P < 0.001). Exploratory factor analysis showed that the cumulative contribution rate of variance reached 68%, and the factor loading of all the items were greater than 0.8. The scores of four items were signicantly different for the patients of different Bristol stool form scale (P < 0.001). The scores of function, worry and general well-being were signicantly different among the patients with different smoking status (P < 0.05). Conclusions: The SHS is a simple and quick scale. The SHS had good validity and reliability, and was suitable to evaluate the QoL of patients with IBD in Chinese.


Background
In ammatory bowel disease (IBD) is a chronic nonspeci c bowel disease of unknown etiology, which includes Crohn's disease (CD) and ulcerative colitis (UC). IBD usually occurs in adolescence and young adulthood, and is characterized by prolonged nonunion and remitting-relapsing disease course (1). IBD is a global disease that poses a great challenge to healthcare systems around the world. In accordance with epidemiological data, the incidence of UC in Europe was as high as 24/100,000, and the CD was 11.5/100,000 in 2015 (2). Ng et al. reported that the incidence of IBD has risen rapidly in Eastern countries while plateauing in Western countries (3). In addition, the long-term symptoms caused signi cant distress, and worsen prognosis. The long-term symptoms and treatments in uenced patients' physiology, emotions, functional status, and social capabilities (4,5). It suggested that clinicians should pay more attention to the quality of life (QoL).
The health-related quality of life (HRQoL) has been widely used to assess clinical e cacy of the patients with IBD in recent years (6, 7). HRQoL is de ned as a broad multidimensional concept, covering questions related to patient's perception, experience, daily function and so on (8). A large number of scales were developed and veri ed to assess the HRQoL for patients with IBD. Fifteen IBD-speci c instruments were developed for the patients with IBD (9). The speci c instruments mainly contained the IBD Questionnaire (IBDQ) (10), the short in ammatory bowel disease questionnaire (SIBDQ) (11), the Rating Form of IBD Patient Concerns (RFIPC) (12) and the Short Health Scale (SHS) (13). Among them, IBDQ has been widely used for the patients with IBD. The reliability and validity of the Chinese version of IBDQ has been initially validated (14).
The SHS was a rapid, sensitive and speci c measurement tool to assess the QoL of patients with IBD in clinical trials and practices (13,15). The SHS was developed by Dr. Henrik from Switzerland in 2006, (13).
It was a self-report tool for IBD using opening-ended questions, so that the patients could consider some aspects important to them in their life. Up to now, The SHS has been translated, validated and used in Sweden (13,15), Norway (16), Ireland (17), Korea (18) and Netherlands (19). The SHS has been proved to be a rapid, valid, reliable and sensitive instrument with the ability to assess the QoL of patients with IBD in these countries. However, the SHS was not translated into Chinese, and not used in Chinese patients with IBD. Therefore, the purpose of this study was to cross-culturally translate and validate the SHS for Chinese patients with IBD.

Material And Methods
Translation and back-translation procedure The researcher contacted Dr. Henrik, the original author of the SHS, and developed the Chinese version after obtaining permission of the SHS. The Chinese version of the SHS was translated and backtranslated according to the Brislin's guidelines for the translation and back-translation method and the standard process for translating instruments (20,21). First, two bilingual (Chinese and English) native researchers independently translated the original text into Chinese. The translation coordinator (one of the authors) integrated and debugged the two Chinese translation versions to form the rst draft of the Chinese version of the SHS. Then, the rst draft of the Chinese version of the SHS was back-translated to English by another two bilingual researchers, who was not involved in the translation section. The backtranslation coordinator (one of the authors) integrated and debugged the two English translation versions to form the English back-translated version. Finally, the research team coordinated and discussed the differences between the English back-translated version and the original English-translated version of the questionnaire. After language and cultural adaptation, the Chinese version of SHS was nally formed.

Validation study
The reliability and validity of the SHS were measured using a cross-sectional study method. The patients with IBD were enrolled from the First A liated Hospital of Guangzhou University of Traditional Chinese Medicine, the First A liated Hospital of Sun Yat-sen University and Shanghai TCM-Integrated Hospital between June 1st and December 1st, 2020. The study was approved by the Ethics Committee of the First The inclusion criteria were patients aged 16-75 years with a de nite diagnosis of IBD. The exclusion criteria were (i) non-IBD patient, (ii) severe cognitive impairment who could not understand the questionnaire and (iii) patients with IBD who refused to participate in the study. Eligible participants completed the questionnaire on their mobile phone or on paper.
The trained researchers explained the purpose of our study to the patients with IBD. After obtaining informed consent of participants, the researchers ask the patients to complete a self-lled case report form (CRF). The CRF contained socio-demographic characteristics, the SHS, and the SIBDQ. The sociodemographic characteristics included age, gender, education, family history, smoking status, drinking history, diagnosis, lesion location and the Bristol stool form scale (BSFS). According to the BSFS, the patients was classi ed into three groups: hard stools (types 1-2), normal stools (types 3-5) and loose stools (types 6-7) (22). If the patients had any question about the CRF, the researchers would explain the CRF and help to solve the problem. Some participants were also required to complete the SHS again, within one week to four weeks after the rst survey.

The SHS
The SHS was a 4-item self-administered questionnaire, which measured the QoL of patients with IBD (13). It consisted of four items: Symptoms, Function, Worry and General well-being. Each item represented a QoL domain. It used open-ended items, which was easily understood by the patients. The items were graded on a 100-mm visual analogue scale (VAS) correlating with score range of 0 to 100. The higher values of VAS indicated worse QoL. The 100-mm VAS was changed into 10-mm VAS ( Figure   1). The patients with IBD were asked to mark the position deemed appropriate on the 10 mm visual analogue scale. In addition, patients with IBD were encouraged to reported other concerns, such as high costs for treatment. These concerns, which did not include in the SHS was also recorded. The result was used to evaluate the content validity of the SHS.

The SIBDQ
The SIBDQ was a shortened version of the IBDQ, which was responsive to important changes in disease activity (11). The SIBDQ consisted of ten items, each having seven answer categories (all of the time, most of the time, a good bit of the time, some of the time, a little bit of the time, hardly any of the time, and none of the time). The items were clustered into four domains: symptoms, systematic symptoms, social function and emotional function. The score of the SIBDQ ranged from 10 (worst QoL) to 70 (best QoL). Higher score represented more higher QoL. The SIBDQ was one of the most commonly speci c scale for measuring QoL of IBD, which had been translated and veri ed in German and Canadian patients with IBD (10, 23) .

Statistical Methods
All the data was inputted to Microsoft O ce Excel 2016 and analyzed by SPSS software (version 25.0) and R software (version 4.0). The normally distributed continuous data were expressed as mean and standard deviation (SD), while the non-normal distribution continuous data were expressed as median and interquartile range (IQR). The categorical variables were presented as percentages (%). The preset pvalue for signi cance was set to 0.05. The correlations between non-normal distribution data were analyzed using Spearman's rank correlation coe cient (r s ).
The validity analysis contained criterion validity, construct validity and discriminant validity. The SIBDQ was used as a criterion scale. Criterion validity were assessed using Spearman correlation coe cient between the SHS and the SIBDQ. The construct validity was estimated using exploratory factor analysis (EFA). Discriminant validity was measured by comparing the QoL of the SHS among different demographic characteristics using Wilcoxon test.
Reliability analysis included internal consistency reliability, split-half reliability, and test-retest reliability. Cronbach's α value was used to assess internal consistency reliability. Split-half reliability was assessed by Pearson's correlation coe cients between two halves of the items. Test-retest reliability was evaluated using Spearman rank correlation coe cients (r s ) and intra-class correlation coe cient (ICC) between test-retest scores Test-retest reliability was evaluated using ICC.

Patient characteristics
A total of 96 patients were enrolled to ll in the CRF. One patient was excluded due to incomplete information, and nally 95 patients were included for analysis (Table 1). Among them, 65.3% of the patients were UC and 34.7% were CD. Sixty-two participants (65.3%) were male, with mean age 38.9 ± 13.8 years. More than half of the patients had normal stools, followed by loose stools and the least was hard stools. was concerned that the symptoms of abdominal pain or increased frequency of defecation would hinder from going out. 3 About half of the patients were afraid that the medicine would cause aggravation or recurrence of IBD and its side effects would lead to low immunity and affect fertility. 4 In addition, some patients wanted to be cured, while another patient concerned about whether he can afford the cost.
Spearman correlation coe cients between the four SHS items and corresponding items from the SIBDQ were calculated (Table 2). Among them, correlation coe cient for SHS General well-being and SIBDQ Systemic symptoms was the highest (r s = -0.63). The correlation coe cient of symptoms item was slightly lower (r s = -0.47). The total score of the SHS was highly correlated with total score of the SIBDQ (r s = -0.68). All correlation coe cients were signi cant (P < 0.001). According to the result of EFA, one factor was extracted to evaluate construct validity ( Table 3). The Kaiser-Meyer-Olkin test (0.76) and Bartlett ball test were performed. The approximate Chi-square value was 238, with P < 0.001. The cumulative variance contribution rate was 68%. The loading factor of all the items were greater than 0.7 (Table 3).   Table 5 showed the score of patients with different demographic characteristics and P-value. The scores of four items were signi cantly different for the patients of different BSFS (P < 0.001). The QoL scores of patients with loose stools (Types 6-7) was the highest in four items of the SHS. The scores of functions, worry, well-being items were not signi cantly different for the patients of different smoking status (P < 0.05). There was no signi cant difference in the scores for the patients of different genders or different diseases (between UC and CD). The QoL scores were presented as medians and IQR (25th-75th percentiles). Comparisons were analyzed using Wilcoxon test or Kruskal-Wallis test.

Discussion
This is the rst study to test and validate the validity and reliability of the SHS for the Chinese patients. The purpose was to provide effective, valid and reliable tools for Chinese patients with IBD.
The SHS is a simple and quick scale for Chinese patients with IBD, which has good operability and acceptability. We changed the visual analogue scale from 10 mm to 0 mm which make it easier for patients to select their own score. The patients with IBD were asked to mark the appropriate position on the 10mm visual analogue scale. The response rate of the scale was 99.0% (95/96). It indicated that the SHS was easy to understand. Moreover, most patients quickly completed the Chinese version of SHS within 1 minute during the investigation. Likewise, the results were consistent with those in other countries (6, [17][18][19]. Accordingly, the SHS is a feasible tool to use for Chinese patients and clinicians.
The Chinese version of the SHS has good content validity. The WHOQOL consisted of six aspects: physical, psychological, independence, social, environment, and spiritual domains (24). According to the results of a review, all the published fteen IBD-speci c scales contained four domains: IBD-related symptoms, physical functioning, emotional functioning and social functioning (9).The structure of the SHS was composed of symptoms, function, worry and general well-being, which was the same as other IBD-speci c scales. The items of the SHS re ected the living conditions or concerns of Chinese patients with IBD. In addition, some patients were also worried about the price of drugs, adverse events and exacerbation.
The Chinese version of the SHS had good criterion validity and construct validity. Criteria validity of the SHS was assessed using correlation coe cients between the SHS domains and the corresponding SIBDQ domains. Criteria validity of most items were greater than 0.5, except the symptom item. The symptom item had slightly lower correlation with the corresponding item of the SIBDQ (0.47). The results were consistent with a study using the SIBDQ as the criterion in Dutch-speaking patients, which scores ranged from 0.403 to 0.828 (19). McDermott et al. translated the SHS into Ireland for English-speaking patients. They used the IBDQ as the criterion, and they reported the correlation coe cients of all SHS items ranged from 0.662 to 0.737.
The correlation coe cients of their study were higher than ours (17). The reason may be related to the selection of different criteria scales.
The internal consistency reliability and split-half reliability of Chinese version of the SHS were good.
Cronbach's alpha value above 0.70 was considered satisfactory (25). Cronbach's alpha of the Chinese version of the SHS was 0.91 (P < 0.001), and it was higher than that of the Norwegian version (0.85) (16).
Split-half correlation coe cients of the Chinese version of the SHS was 0.83, which indicated high internal consistencies between the halves. Overall, both the internal consistency reliability and split-half reliability of the Chinese version of the SHS was high.

Consent for publication
All of the authors listed have seen the contents of the manuscript and agree with the submission.

Availability of data and materials
Xin-lin Chen and Bin Peng had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests
The authors declare no competing interests.
plan) of Guangzhou University of Chinese Medicine (XH20190102) and The Natural Science Foundation of Guangdong Province(2015A030313360).

Contributions
XLC, JTH and BP were involved in construct de nition, the validation study and data analysis. BP and SJZ wrote the manuscript. YX Land JZC involved data analysis. YMC and YW were involved in language testing, content validity. JFL, XMZ and SMP were involved in item generation and collected the data. SYL and HM modi ed the manuscript. XLC and BC designed the study. All authors read and approved the nal manuscript. Figure 1 The SHS was a 4-item self-administered questionnaire, which measured the QoL of patients with IBD