Background
Infertility is defined as the inability to conceive after at least 12 months of unprotected intercourse [
1‐
3]. The infertility rate of couples of childbearing age in China has risen from 2.5 to 3% to around 12 to 15% in 20 years, and the number of patients has exceeded 50 million [
4‐
6]. Infertility and its treatment have negative impacts on a couple’s marital relationship, sexual life, psychological state and interpersonal relationships, causing personal distress [
7‐
9]. With the increasing aging trend in China, infertility has also become an important public health and social problem [
4,
5]. In order to raise the fertility level, the three-child policy has been implemented in China [
10].
Health-related quality of life (HRQoL) is a multi-dimensional concept that represents the patient’s overall perception of the impact of an illness and its treatment. It includes an individual’s physical, psychological, social aspects of life and has become an important component of health outcomes [
11]. Since HRQoL is a culturally relevant concept, people from different cultural backgrounds tend to have different understandings of HRQoL [
12,
13]. Western HRQoL instruments are not always appropriate for use in China due to cultural differences between the East and West [
13,
14]. It is worth mentioning that there are fundamental differences between Chinese and Western fertility concepts. Infertility patients in China seem to be more influenced by the traditional Chinese saying, “There are three forms of unfilial conduct, of which the worst is to have no descendants” [
15], meaning that it is unacceptable for people not to have offspring. Accordingly, infertility patients can be looked down upon and their families may feel shameful [
16,
17]. Women tend to be especially subject to more blame and prejudice than men in the Chinese traditional cultural setting [
16].
Disease-specific HRQoL instruments have been developed among infertility patients in previous studies [
9,
18,
19]. The fertility quality of life (FertiQoL) scale is currently the most commonly used disease-specific HRQoL scale for infertile couples [
18,
20]. However, empirical studies have shown that some items in the FertiQoL are poorly understood in a Chinese cultural setting and irrelevant to the Chinese health service system [
21]. Generic HRQoL instruments such as EuroQol-5 dimensions-5 levels (EQ-5D-5L), Medical Outcomes Study 36-Item Health Survey (SF-36), WHO Quality of Life Measure (WHOQOL-BREF) have been frequently used to assess HRQoL among infertility patients [
9,
22,
23]. However, the generic measures are not able to include important disease-specific domains, which are useful to detect clinical changes specific to infertility. For example, when EQ-5D-5L was used to measure the HRQoL of infertile patients in China, it was found that the health dimensions of EQ-5D-5L were insufficient, causing a seriously high “ceiling effect” [
23].
To the best of our knowledge, there was only one infertility quality of life instrument developed in China [
24]. It focused on those female patients with liver depression and was based on the theory of traditional Chinese medicine, which limited their application scope. More importantly, the development of the instrument did not include qualitative interviews with infertility patients.
Objectives
This study aims to develop a de novo HRQoL instrument for infertile couples in China and evaluate its psychometric properties, with the hope of providing a validated HRQoL instrument for the Chinese population.
The specific objectives of the study are :
1.
Develop a de novo HRQoL instrument for Chinese infertile couples;
2.
Evaluate the reliability, validity, and sensitivity/responsiveness of the instrument;
3.
Develop the minimal clinically important difference (MCID) of the instrument and provide thresholds for the interpretation of the results.
Discussion
Infertility and its treatment have negative impacts on a couple’s marital relationship, sexual life, psychological state and interpersonal relationships, causing personal distress [
7‐
9]. Identifying these factors in infertility patients, creating a good medical environment and offering diverse health education can help improve their health. The new HRQoL instrument for Chinese infertile couples will be developed, which will provide a standard and effective HRQoL instrument in clinical outcome assessment and health outcome measurement.
This study has several advantages. Firstly, the new HRQoL instrument for use among Chinese infertile couples will be developed by using a mixed method. MCID development will provide a benchmark for interpreting mean differences. Secondly, infertility patients and reproduction medicine clinicians will be surveyed from seven reproductive medicine centers to diversify the sample as much as possible, according to the geographical location and economic development level in China. It will provide a comprehensive view of problems encountered by infertility patients. Thirdly, CTT and IRT will be used for item selection and validation, which will fill in the gap that the existing infertility HRQoL instruments development were only based on CTT.
This study also has certain weaknesses. First of all, this study will investigate infertility patients treated in hospitals, and there may be some selection bias in the samples. Future studies may evaluate the psychometric properties in a larger population. In addition, some post information on Zhihu may have low reliability.
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