Fibroids are the most common benign uterine tumour affecting reproductive age women, and the lifetime risk is up to 60% in women aged over 45 years.1 2 They are associated with menorrhagia,3 4 which results in anaemia and reduced vitality.5 They also exert mass effects, leading to significantly increased urinary frequency and stress urinary incontinence compared with the general population.6 Moreover, women with fibroids may experience deep dyspareunia.7 All the above have negative effects on quality of life.

Measuring the symptoms and quality of life of women with fibroids is important, as it is a major indicator for treatment. The Uterine Fibroid Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) is an English questionnaire published in 2002 that was specially designed to assess the whole spectrum of fibroid-related symptoms and its impact on quality of life.8 It consists of eight items on symptoms and 29 on health-related quality of life (HRQL) with six subscales (concern, activities, energy/mood, control, self-consciousness, and sexual functioning). A raw score ranging from 1 to 5 is assigned to each of the items. To calculate the symptom severity score and HRQL score, the sum of the raw scores of the related items is transformed into a final score (range, 0-100) based on a specific formula. A higher symptom severity score indicates more severe symptoms, while a higher HRQL score indicates better quality of life. The UFS-QOL has been validated, and its responsiveness was also assessed.8 9 10 It has been widely adopted in different studies to assess fibroid treatment outcomes11 12 and translated into multiple languages.13

The objective of this study was to produce a valid, reliable, culturally adapted Chinese version of the UFS-QOL. We believe this would serve as a useful tool to assess the impact of fibroid-related quality of life and response to treatment and facilitate future research and clinical use in the Chinese population.

We obtained approval to use the UFS-QOL from the Society of the Interventional Radiology Foundation. A forward-backward procedure was applied to translate the UFS-QOL into traditional Chinese. Two independent bilingual researchers were asked to separately produce two forward translations aiming for conceptual translation. The two translations were reviewed between the two researchers to produce a provisional draft of the Chinese UFS-QOL. The provisional Chinese UFS-QOL was then back-translated to English by two other bilingual researchers who were blinded to the original questionnaire. The back-translated English version was further compared to the original questionnaire by two monolingual experts (English) with no discrepancy noted before we finalised the Chinese version of the UFS-QOL (online Supplementary Appendix)

The study was conducted in the gynaecology clinic of a university hospital between July 2015 and July 2016. All women aged ≥18 years with fibroids who understood written traditional Chinese were eligible. Women with known mental incapacity or cognitive or developmental disability were excluded. The Mini-Mental State Examination was performed to detect and exclude women with unreported psychiatric morbidity. Written consent was obtained.

Women were asked to fill out the Chinese UFS-QOL and Short-Form Health Survey-12 (SF-12) before consultation. The SF-12 is a 12-item survey that assesses eight domains of quality of life (physical functioning, role limitation as a result of physical and emotional problems, bodily pain, general health, vitality, social functioning, and mental health), and it has a validated Chinese version.14 Lower SF-12 scores are associated with worse HRQL.

The participating women were assessed by gynaecologists who were blinded to the questionnaire information. Clinical and socio-demographic data including age, gravidity, parity, co-existing medical illness, menstrual status, education level, marital status, literacy, and employment status were obtained. General examinations to examine the subjects for pallor and measure their blood pressure, pulse, body weight, and height were performed. Abdominal and/or gynaecological examinations were performed to assess the uterine size and rule out other pathology. Transabdominal and/or transvaginal ultrasound were performed to measure uterine size and the number, location, and size of fibroids. Complete blood work was performed. Both the women and the attending gynaecologists were asked to grade the overall severity of symptoms on a 10-cm visual analogue scale (VAS), with higher scores indicating more severe symptoms.

The women maintained a pictorial blood loss assessment chart (PBAC) for two menstrual cycles. The PBAC is a validated self-reporting tool with a score calculated every 4 weeks.15 A score ≥100 represents heavy menstrual bleeding, and ≤75 represents normal menses.

The first 60 women filled out the two questionnaires again 2 weeks later and returned them by mail to researchers. In addition, a question on perceived change in clinical condition over the past 2 weeks was asked.

Women were offered appropriate treatment as clinically indicated. In general, tranexamic acid 500 mg 4 times daily and/or mefenamic acid 500 mg 3 times daily were prescribed for menorrhagia unless contra-indicated. Combined oral contraceptive pills were given if contraception was required and when there was no contraindication. If medical treatment failed, treatment including endometrial ablation, a levonorgestrel-containing contraceptive device, myomectomy or hysterectomy, or uterine artery embolisation (UAE) were offered.

The first half of the recruited women were followed up 6 months later. They were asked to perform PBAC, and complete blood work was performed. During follow-up, the women filled out the above questionnaires again before the gynaecologist’s assessment. The women were also asked about improvement after treatment.

A sample size of five or more respondents per item has been proposed for psychometric analysis.16 17 With the UFS-QOL’s total of 37 items and assuming a 20% discard rate due to incomplete filling of questionnaires, a sample size of 220 was required to adequately assess the questionnaire.18

We used SPSS (Windows version 20.0; IBM Corp, Armonk [NY], United States) for statistical analysis. The psychometric properties of the UFS-QOL were assessed following the American Psychological Association’s Standards for Educational and Psychological Testing.19

Reliability was assessed by internal consistency and test-retest correlation. Internal consistency was assessed by Cronbach’s alpha coefficients, with >0.7 being considered acceptable.16 17 Test-retest reliability was analysed in women who reported no change to health status over the 2-week period from the first questionnaire. Test-retest reliability was assessed by intra-class correlation coefficient. Values between 0.6 and 0.8 indicate substantial agreement, and values over 0.8 indicate near-perfect agreement.20

The convergent validity of the UFS-QOL was estimated by Pearson’s correlation, with participant-rated symptom severity VAS score, PBAC score, and physician-rated symptom severity VAS score as well as the quality of life domains of the SF-12. For discriminant validity, the women were stratified into mild, moderate, and severe symptoms according to the women-rated symptom severity VAS scores. A score of VAS ≤4 was classified as mild, while ≥7 was classified as severe symptomatology. The UFS-QOL scores were compared among the three groups.

Responsiveness was evaluated by comparing pre- and post-treatment scores using paired samples t tests or Wilcoxon signed rank tests. The effect size (ie, change in mean score divided by the standard deviation of the baseline)20 and standardised response mean (ie, change in mean score divided by the standard deviation of the change) were calculated. A value of 0.2 was considered as a ‘small’ effect, 0.5 a ‘moderate’ effect, and ≥0.8 a ‘large’ effect.

A total of 223 women were recruited. Their mean age was 44.8±6.0 years (range, 28-62 years). There were multiple fibroids in 54.5% of the participants, and 51.6% of the women had uterine size ≥12 weeks. Overall, 28.3%, 73.3%, 47.1%, and 29.1% reported cycle irregularity, menorrhagia, dysmenorrhoea, and pressure symptoms from fibroids, respectively, while 12.1% were asymptomatic. The median UFS-QOL score at recruitment was 40.6 (interquartile range [IQR]=25.0-56.3) and 67.2 (IQR=48.3-83.6) for symptom severity and HRQL, respectively.

The internal consistency and test-retest reliability values are shown in Table 1. The Cronbach’s alpha values of all subscales were >0.7. Fifty-one women (85%) returned the questionnaire 2 weeks after the initial visit. All of them reported no health changes. Test-retest reliability indicated substantial to perfect agreement.

Convergent validity was assessed by the degree of correlation of the UFS-QOL symptoms severity score on the one hand with the women-rated and physician-rated VAS scores and PBAC score on the other. There was a moderate degree of correlation between the UFS-QOL and these assessment tools (Table 2).

A negative correlation was seen between the UFS-QOL symptom severity subscale and all domains of the SF-12, and a positive correlation was observed between the HRQL subscales and SF-12 domains. The energy/mood and activities subscales had the strongest correlation with the role-emotional domain of the SF-12 (r=0.597, P<0.001).

The UFS-QOL scores for symptomatic and asymptomatic women were significantly different across all subscales (median symptom severity score: 43.8 vs 21.9, P<0.001; median HRQL score: 79.3 vs 63.8, P<0.001). For women with clinically palpable uterus, the scores on the control and self-consciousness subscales were lower than those of women with smaller uterus size (median score of control subscale: 65.0 vs 75.0, P=0.025; median score of self-consciousness subscale: 67.0 vs 75.0, P=0.015). Women with significant anaemia (haemoglobin level <80 g/L) had lower energy and activity subscale scores (median energy score: 50.0 vs 67.9, P=0.014; median activity score: 42.9 vs 66.1, P=0.013) than women who were not anaemic had.

Women were classified into three groups (mild, moderate and severe symptoms) according to their symptom severity VAS score (≤4, 4.1-7, and ≥7). Higher women-rated severity score was associated with higher UFS-QOL symptom severity score, with significant differences between different severity groups. Similarly, higher women’s VAS severity score was associated with lower UFS-QOL HRQL scores. The differences in UFS-QOL score among the three groups were statistically significant (P<0.001) for all except the mild versus moderate groups on the sexual functioning subscale (Fig).

Among the 100 women being followed up, 50 received medical treatment, 21 received surgery and UAE (15 hysterectomies, 4 myomectomies, 2 UAE), and 29 did not receive any treatment. There was a significant reduction in symptom severity score and improvement in HRQL subscale scores after any treatment, except on the sexual functioning subscale (Table 3). Despite the results being statistically insignificant, the sexual functioning subscale still showed a trend towards quality of life improvement with treatment. For surgically treated women, the reduction in symptom severity score ranged from 22 to 38 with a large effect size (range, 0.8-2.6).

For women reporting no improvement (n=53), reduction in symptom severity scores and improvement in HRQL scores were modest except for the control subscale (P=0.027). For those participants who reported improvement (n=47), there was a significant reduction in symptom severity score and improvement in HRQL scores. The changes were significant except for the sexual functioning subscale (P=0.14). Women who reported improvement demonstrated greater improvement in symptom severity and all HRQL subscales by 7 to 19 points. The differences were significant for all except the energy/mood and sexual functioning subscales (Table 4).

Fibroids are common in women, and the Chinese population is no exception. Newer treatments such as ulipristal acetate and high intensity focused ultrasound ablation can shrink fibroids to improve symptoms.21 22 23 24 Assessment of effects on quality of life is essential for evaluation of the usefulness of these modalities.

The UFS-QOL is a simple, disease-specific tool that has been used in various studies to assess treatment outcomes. The Chinese version of the UFS-QOL needs to be validated before application for clinical and research purposes because of cultural differences and language-specific concerns.

Our results showed that the Chinese UFS-QOL is a reliable tool with high internal consistency (Cronbach’s alpha >0.7 for all subscales) and almost perfect agreement between test and retest results (intra-class correlation coefficient >0.8 for all except the sexual functioning subscale). These results are comparable with the original and other translated version of the UFS-QOL.8 13

The validity of the Chinese UFS-QOL was supported by moderate positive correlations between the women-rated VAS score, physician-rated VAS score, PBAC score, and UFS-QOL symptom severity score (with correlation coefficients ranging 0.3-0.6). There was also a moderate positive correlation between the SF-12 and UFS-QOL HRQL subscale scores. The energy/mood domain of the UFS-QOL had the strongest correlation with the SF-12 role-emotion domain (r=0.597). Women with larger uterus size scored lower in the control and self-consciousness domains, and those with significant anaemia also had lower energy and activity scores. These results reflected the ability of the Chinese UFS-QOL to assess the underlying constructs.

The Chinese UFS-QOL also demonstrated responsiveness towards change in women who received treatment. The mean change in subscale scores ranged from 6 to 15 points at 6 months post-treatment. The changes were most pronounced for women who received surgery (myomectomy or hysterectomy), who had a mean score increase from 22 to 39 and an effect size of ≥0.8 for all subscales. Similar findings were also reported in a previous study.23 In addition, larger score changes was observed in women who received surgery compared with medical treatment, an effect that has also been shown in other studies.24 The Chinese UFS-QOL was able to discriminate between women who reported that their treatment was effective compared with those who did not. Although there were mean increases of 7 points in both the energy/mood and sexual functioning subscales, they did not reach statistical significance. This might be explained by the fact that mood and sexual satisfaction could be affected by multiple factors other than fibroid symptoms alone. Improvement in fibroid-related symptoms alone might not result in dramatic changes in these aspects of quality of life.

Our study sample included a wide range of disease severities and a broad symptom spectrum, which allows generalisation of the findings to the community of women with fibroids. Another strength is that the responsiveness of the UFS-QOL was evaluated, which allows its use to assess treatment effects. However, the study has a few limitations. The minimal important difference, ie, the smallest clinically significant change in score large enough to implicate treatment, was not assessed. In addition, the majority of women who returned for follow-up received either medical treatment or hysterectomy, whereas few underwent myomectomy or UAE. Further studies may be required to address these issues. Finally, there are two forms of written Chinese characters (traditional and simplified). Because the Chinese UFS-QOL is a self-administered questionnaire written in traditional Chinese, application to women who can read only simplified Chinese characters may be limited.

Our study showed that the Chinese version of UFS-QOL is comparable to the original and other translated version of this questionnaire in terms of reliability, validity,8 9 13 and responsiveness.10 In conclusion, the Chinese version of the UFS-QOL is a reliable, valid tool for the assessment of symptom severity and HRQL. It can be used to evaluate efficacy and treatment effects on fibroids in women in the future.

All authors had full access to the data, contributed to the study, approved the final version for publication, and take responsibility for its accuracy and integrity.

Concept or design: SY Yeung, SM Law, SSC Chan.
Acquisition of data: SY Yeung, SM Law, JWK Kwok.
Analysis or interpretation of data: SY Yeung, JWK Kwok.
Drafting of the article: SY Yeung.
Critical revision for important intellectual content: SM Law, SSC Chan, JPW Chung.

The authors thank Dr Linda WY Fung for performing the forward translation, Dr Alyssa SW Wong for the backward translation, Professor Sonia Grover and Dr Sotirios Saravelos for evaluating the final English version against the original questionnaire.

As an editor of the journal, JPW Chung was not involved in the peer review process of the article. Other authors have disclosed no conflict of interest.

The preliminary results of part of this study (reliability and validity) have been presented during an oral presentation session at the 25th Asian & Oceanic Congress of Obstetrics & Gynaecology in Hong Kong, June 2017.

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Ethics approval was obtained in April 2015 from the Joint Chinese University of Hong Kong–New Territories East Cluster Clinical Research Ethics Committee (CREC Ref 2015.085).

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