In this study, we analyzed the reliability and validity of the Chinese Mandarin version of PedsQL™ 3.0 Transplant Module. The results of this large scale analysis showed that the return rates of parent proxy- and child-self reports were 100 and 85.2 %, respectively. The smaller the missing item rate, the better feasibility of the survey; previous studies have found an average missing rate for the PedsQLTM 3.0 Transplant Module of less than 1 % [
1,
2]. No missing item response was found in this study, which confirmed that the Chinese Mandarin version of PedsQLTM 3.0 Transplant Module had good feasibility.
Similar to most previous studies, we found good reliability in this study. Cronbach’s alpha coefficients exceeded 0.7 in the total scale and every dimension in both parent proxy reports and child self-reports, indicating good reliability. However, these values were higher than those described in previous reports assessing patients with a wide range of diseases in other countries, with values generally over 0.7 but around 0.6 for some dimensions [
13,
16,
18,
21].
Content validity and construct validity were also analyzed in the current study. Content validity determines whether items can represent the content/theme or not. Spearman’s rank correlation coefficient >0.5 indicates a moderate association, while a value > 0.8 suggests a high association. In contrast, values < 0.5 and 0.3 represent weak and very weak associations, respectively. Our results showed moderate to high association between items and their respective dimensions, but weak associations with other dimensions, indicating that the Chinese version has good content validity. Exploratory factor analysis was utilized to examine the construct validity of the scale. Ten common factors were extracted, which conformed to the theory structure of the scale and involved every item. The results showed cumulative contribution rates >60 % in both parent proxy- and child self-reports, indicating a good extraction effect. Thus, the Chinese Mandarin version of PedsQL™ 3.0 Taken together these results indicated that the Transplant Module has good construct validity, in agreement with previous studies. Indeed, PedsQL was originally designed to evaluate health-related quality of life in 2–18 year patients, with the PedsQL 3.0 Cancer Module specific for pediatric cancer [
20]. This pioneer work demonstrated that all parent proxy-report scales of PedsQL 3.0 Cancer Module met or exceeded the minimum reliability standard of 0.70, with a proven validity for the module [
20]. In addition, the PedsQL 3.0 Transplant Module was used to assess pediatric solid organ transplant recipients of liver, kidney, heart and small bowel, supporting its excellent feasibility, reliability and construct validity in pediatric patients with solid organ transplants [
8]. Nevertheless, the PedsQL 3.0 Transplant module was not primarily designed for HSCT. Nevertheless, a previous study showed that both the PedsQL 3.0 solid transplant and HSCT modules were highly correlated [
22]. Nevertheless, it is the only PedsQL questionnaire that is currently validated in Mandarin. It is very critical to assess patient experience during treatment for pediatric cancer; several questionnaires, such as PedsQL 4.0, PedsQL 3.0, PedsQL Multidimensional Fatigue Scale, and the Pediatric Inventory for Parents have been used to this end in other countries [
22]. Therefore, HSCT specific PedsQL modules, such as PedsQL 4.0 Generic Core Scales, should be evaluated for the assessment of HRQoL in pediatric patients after HSCT in China.
This study has some limitations. The patient information in all cases could not be kept completely anonymous as some patients were surveyed by phone or email; this may have introduced some bias. This study included patients from three hospitals, but a better accuracy of results would be expected from multiple centers throughout China. Collecting patients from only 3 hospitals is likely to have some level of selection bias. When grouping the patients by age, some groups had a small sample size, with a limited number of disease types. More patients from multiple centers would address these concerns, and should be assessed in the future before the Chinese Mandarin version of PedsQL™ 3.0 Transplant Module is applied throughout China.