POI life quality scale generation method and device

Abstract

The invention provides a POI life quality scale generation method and device. The method comprises the following steps: constructing a theoretical framework of a POI life quality scale based on a traditional Chinese medicine theory; generating an original life quality entry pool according to a theoretical framework of a POI life quality scale; optimizing and screening items in the original life quality item pool to obtain a target life quality item pool; optimizing the target life quality entry pool to generate a POI life quality initial scale; and optimizing and testing the POI life quality initial scale, and determining and evaluating a final POI life quality scale according to a test result. According to the method, the theoretical framework of the POI life quality scale is constructed through the traditional Chinese medicine theory, the original life quality entry pool with the traditional Chinese medicine characteristics is extracted according to the theoretical framework, and the original life quality entry pool is optimized for multiple times, so that the finally obtained POI life quality scale can accurately evaluate the life quality of a POI patient.

Description

Technical Field

[0001] The present invention relates to the technical field of chronic diseases, and in particular to a method and device for generating a POI quality of life scale. Background Art

[0002] Premature Ovarian Insufficiency (POI) is a chronic gynecological disease with complex etiology, long course and difficult treatment. It refers to the progressive development process of ovarian dysfunction to failure in women before the age of 40. In recent years, the prevalence of POI has been on the rise, and the age of onset has also tended to be younger. POI has diverse clinical manifestations, often accompanied by menstrual disorders, decreased fertility, and perimenopausal symptoms such as hot flashes, sweating, and insomnia. Its clinical manifestations and the psychological, family, and social problems it brings have seriously affected the physical and mental health and quality of life of POI patients. Quality of life (QoL) is a multidimensional structure that includes physical, psychological, and social health and happiness from an individual's perspective. Using the QoL scale as an evaluation tool to evaluate the patient's QoL can comprehensively reflect the patient's health status, objectively and quantitatively evaluate the treatment effect, accurately identify the more prominent problems in the patient's life, and solve or improve them in a targeted manner, thereby promoting the improvement of their quality of life. Many studies have shown that the QoL of POI patients is reduced, so early assessment and intervention of POI patients is one of the important means to improve their quality of life. Compared with Western medicine, traditional Chinese medicine has special advantages in improving the clinical symptoms of POI patients, regulating their emotions and improving their quality of life.

[0003] At present, the clinical practice mostly adopts the form of combined scales, that is, the universal QoL scale combined with the specific scale related to POI symptoms to evaluate the QoL of POI patients. However, universal scales such as the World Health Organization Short Form and SF-36 have many questions and symptom descriptions that are not related to POI, and there is no research evidence to prove their sensitivity to POI in the psychological field; while specific scales are often designed for patients with menopausal syndrome, such as the domestic modified Kupperman Index scale and the menopausal quality of life scale, which are applicable to different subjects and ages, and the evaluation of symptoms and efficacy of POI patients is mostly limited to evaluating one of the clinical manifestations of the disease, that is, perimenopausal symptoms caused by low estrogen. Moreover, most of the scales used in clinical practice are introduced from abroad and translated into Chinese. Due to differences in cultural backgrounds between China and the West, citing foreign evaluation standards often cannot accurately reflect the quality of life of Chinese women with POI.

[0004] In summary, the existing scales cannot accurately assess the quality of life of POI patients, such as menstrual abnormalities, decreased fertility, and the emotional changes and social impacts brought about. Therefore, it is necessary and of great significance to develop a POI quality of life scale that conforms to China's national conditions, reflects the characteristics of traditional Chinese medicine, and has high reliability and validity. Summary of the invention

[0005] The purpose of the present invention is to solve the defects of the above-mentioned prior art and provide a method and device for generating a POI quality of life scale.

[0006] A method for generating a POI quality of life scale, comprising:

[0007] Step 1: Based on the theory of traditional Chinese medicine, construct the theoretical framework of the POI quality of life scale; the theoretical framework includes: physiological domain framework, psychological domain framework, and social domain framework;

[0008] Step 2: Extracting quality of life items with TCM characteristics based on the physiological domain framework, psychological domain framework, and social domain framework to form an original quality of life item pool;

[0009] Step 3: Optimizing and screening the items in the original quality of life item pool to obtain a target quality of life item pool;

[0010] Step 4: Using the Delphi expert consultation method, the items in the target quality of life item pool are optimized again, and the POI quality of life initial scale is generated based on the optimized target quality of life items;

[0011] Step 5: Optimizing the POI quality of life initial scale to obtain an optimized POI quality of life initial scale;

[0012] Step 6: testing the optimized POI quality of life scale by investigating the research subjects, and determining the final POI quality of life scale based on the test results;

[0013] Step 7: Evaluate the reliability, validity, discrimination and feasibility of the final POI quality of life scale.

[0014] Furthermore, in the above-mentioned POI quality of life scale generation method, in step 1, the construction of the physiological domain framework includes:

[0015] Taking the kidney as the main factor and the five internal organs as the related factors, the functions of different internal organs and their pathological changes and clinical manifestations as the core, eight aspects related to the physiological field were screened out, namely: menstruation, leucorrhea, fertility, physical symptoms, sleep, defecation, diet, and complexion;

[0016] The construction of the psychological domain framework includes:

[0017] With the seven emotions and the functions of the five internal organs interacting physiologically and influencing each other pathologically as the core, seven aspects related to the psychological field were selected: joy, anger, worry, thinking, sadness, fear, and shock;

[0018] The construction of the social domain framework includes:

[0019] Taking the unity of man, nature and social environment as the core, three aspects related to the social field are selected: social relations, daily life and work, and medical care.

[0020] Furthermore, in the above-mentioned POI quality of life scale generation method, the step 2 comprises:

[0021] Based on literature analysis, medical record review, and patient interviews, items related to the physiological domain framework, psychological domain framework, and social domain framework were extracted to form the original quality of life item pool;

[0022] The entries corresponding to the physiological domain framework, the psychological domain framework, and the social domain framework are relevant sentences or words with characteristics of traditional Chinese medicine.

[0023] Furthermore, in the above-mentioned POI quality of life scale generation method, step three comprises:

[0024] The target quality of life item pool is obtained by merging items with similar meanings in the original quality of life item pool and deleting items whose correlation with the quality of life of POI patients is lower than a preset value.

[0025] Furthermore, in the above-mentioned POI quality of life scale generation method, step 4 comprises:

[0026] Step 41: Using the results of the first round of Delphi expert consultation, delete 2 items in the target quality of life item pool and add 2 items; at the same time, refine and modify some of the original items to obtain the first round of optimized item pool; among them, the 2 deleted items are: abnormal vaginal discharge and complexion; the 2 newly added items are: actively understanding and seeking treatment options and confidence in treatment; the first round of optimized item pool includes: 38 items and 2 overall evaluations;

[0027] Step 42: using the results of the second round of Delphi expert consultation, deleting some items in the first round of optimized item pool, and modifying some items, and finally generating the POI quality of life initial scale;

[0028] The POI quality of life initial scale includes 31 items and 2 overall evaluations.

[0029] Furthermore, in the above-mentioned POI quality of life scale generation method, step five comprises:

[0030] Step 51: Select a number of patients who meet the POI diagnostic criteria and a corresponding number of healthy people, and conduct a language test on the POI quality of life initial scale to obtain the time to complete the POI quality of life initial scale and the problems encountered in the process of filling in the initial scale;

[0031] Step 52: According to the time of completing the scale and the existing problems, the items in the POI quality of life initial scale are optimized by adjusting the questioning method and modifying the item options without changing the meaning of the items, thereby obtaining the optimized POI quality of life initial scale.

[0032] Furthermore, in the above-mentioned POI quality of life scale generation method, step six comprises:

[0033] Step 61: Selecting research subjects, and grouping the research subjects into a POI group, a POI retest group, a POI+WHO group, and a healthy control group; the research subjects include a POI group and a healthy group;

[0034] Step 62: Performing a scale test on the POI group, the POI retest group, the POI+WHO group, and the healthy control group, respectively, to obtain a score corresponding to each item in the scale;

[0035] Step 63: Perform statistical analysis based on the score of each item, and determine the final POI QOL scale based on the analysis results.

[0036] Furthermore, in the above-mentioned POI quality of life scale generation method, step 62 comprises:

[0037] The POI group performs preliminary tests on the general situation survey scale and the optimized POI quality of life initial scale to obtain the scores corresponding to each item in the corresponding scale; and records the time of filling in the general situation survey scale and the target POI quality of life scale, as well as the areas where the respondents do not understand or have questions about the target POI quality of life scale during the filling process;

[0038] The POI retest group retests the general situation survey scale and the optimized POI initial quality of life scale within 24 hours of the initial test to obtain the scores corresponding to each item in the corresponding scale; the POI retest group is a retest group composed of a number of POI retest patients randomly selected from the POI group;

[0039] The POI+WHO group was tested on the day of consultation on the general situation survey scale, the optimized POI initial quality of life scale, and the World Health Organization quality of life measurement scale brief form to obtain the scores corresponding to each item in the corresponding scales; the POI+WHO group was a patient group composed of several patients randomly selected from the POI group;

[0040] The general condition questionnaire and the optimized POI quality of life initial scale are respectively tested by the healthy group to obtain the scores corresponding to each item in the corresponding scale;

[0041] Furthermore, in the above-mentioned POI quality of life scale generation method, step 63 comprises:

[0042] The scores of all items were statistically analyzed using four or more of the frequency distribution method, discrete trend method, Cronbach's coefficient method, correlation analysis method, factor analysis method, and discrimination analysis method, and the final POIQOL scale was determined based on the analysis results.

[0043] A device for executing any of the above methods for generating a POI quality of life scale comprises:

[0044] A construction unit is used to construct a theoretical framework of the POI quality of life scale based on traditional Chinese medicine; the theoretical framework includes: a physiological domain framework, a psychological domain framework, and a social domain framework;

[0045] An extraction unit, used to extract quality of life items with characteristics of traditional Chinese medicine according to the physiological domain framework, the psychological domain framework, and the social domain framework, to form an original quality of life item pool;

[0046] A processing unit, configured to optimize and screen the items in the original quality of life item pool to obtain a target quality of life item pool;

[0047] An optimization unit, used to optimize the items in the target quality of life item pool again by using the Delphi expert consultation method, and generate an initial POI quality of life scale according to the optimized target quality of life items;

[0048] The optimization unit is further used to optimize the POI initial quality of life scale to obtain an optimized POI initial quality of life scale;

[0049] A testing unit, used for testing the optimized POI quality of life initial scale by investigating research subjects;

[0050] A determination unit, used for determining a final POI quality of life scale according to the test results;

[0051] The evaluation unit is used to evaluate the reliability, validity, discrimination and feasibility of the final POI quality of life scale.

[0052] Beneficial effects:

[0053] The POI quality of life scale generation method and device provided by the present invention construct a theoretical framework of the POI quality of life scale through the theory of traditional Chinese medicine, and extract quality of life items with traditional Chinese medicine characteristics based on the theoretical framework, and then perform a series of processing and optimization on the generated items, so that the final POI quality of life scale can accurately evaluate the quality of life of POI patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Figure 1 A flow chart of the method for generating the POI quality of life scale provided by the present invention;

[0055] Figure 2 This is the theoretical framework diagram of the premature ovarian insufficiency quality of life scale for the physiological domain;

[0056] Figure 3 This is a structural block diagram of the device for generating a quality of life scale provided by the present invention. DETAILED DESCRIPTION

[0057] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention is described clearly and completely below. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0058] The holistic concept emphasized by traditional Chinese medicine is similar to and coincides with the concept of QoL in modern medicine. The theoretical system, clinical practice and efficacy evaluation criteria of traditional Chinese medicine are also highly consistent with modern QoL evaluation, so it is feasible to apply the QoL scale to the clinical efficacy evaluation of traditional Chinese medicine. Therefore, under the guidance of traditional Chinese medicine theory, the present invention refers to the international universal scale and the development method of the traditional Chinese medicine quality of life scale, and uses literature analysis, case review, patient interview, Delphi expert consultation, preliminary investigation and clinical investigation to develop a POI quality of life scale that conforms to China's national conditions and reflects the characteristics of traditional Chinese medicine, and evaluates the reliability and validity of the scale. Characteristics and discrimination, feasibility, in order to provide a reliable evaluation tool for the quality of life evaluation of POI patients and enrich the clinical efficacy evaluation system of traditional Chinese medicine for the treatment of POI.

[0059] Figure 1 The flow chart of the method for generating the POI quality of life scale provided by the present invention is as follows: Figure 1As shown, the present invention provides a method for generating a POI quality of life scale, comprising:

[0060] Step 1: Based on the theory of traditional Chinese medicine, construct the theoretical framework of the POI quality of life scale; the theoretical framework includes: physiological domain framework, psychological domain framework, and social domain framework.

[0061] Specifically, before constructing the POI quality of life scale, a core group was first established, which consisted of senior gynecologists, nurses, scale development experts, statistics experts, gynecology graduate students, POI patients and healthy people. The formulation of the POI quality of life scale was completed by the interactive work of the two groups. The POI quality of life scale assessment scale provided by the present invention is assessed by patient self-assessment, which is suitable for evaluating the quality of life of POI patients and the clinical efficacy of traditional Chinese medicine. At present, there are few studies on quality of life scales designed specifically for POI patients. Scales commonly used in clinical practice to evaluate the quality of life of POI patients, such as the MENQOL scale, include four areas: social and psychological state, vasomotor symptoms, physiological state, and sexual life; the KI scale lacks classification of fields, and the items include physical symptoms, psychological symptoms, and urogenital system symptoms. Traditional Chinese medicine believes that "Yin Ping Yang Mi" is health, which includes the definition of health by the World Health Organization WHO. Therefore, based on the holistic view of traditional Chinese medicine, the present invention preliminarily constructs the theoretical framework of the POI quality of life scale under the guidance of the theories of "unity of form and spirit", "correlation of seven emotions" and "correspondence between heaven and man" in traditional Chinese medicine, which includes three domain frameworks: physiological domain framework, psychological domain framework and social domain framework.

[0062] The POI quality of life scale generation method provided by the present invention constructs a physiological field framework, a psychological field framework, and a social field framework through the theory of traditional Chinese medicine, and generates a POI quality of life scale through the three frameworks, so that the scale can comprehensively evaluate POI patients, thereby improving the evaluation accuracy of the scale.

[0063] Furthermore, the construction of the physiological domain framework includes: taking the kidney as the main body, being related to the five internal organs, and taking the functions of different internal organs and their pathological changes and clinical manifestations as the core, and screening out 8 aspects related to the physiological domain, namely: menstruation, leucorrhea, fertility, physical symptoms, sleep, defecation, diet, and complexion.

[0064] Specifically, the Neijing puts forward the viewpoints of "body and spirit are together", "body and spirit are treated together", and "body and spirit are nurtured together", emphasizing the dialectical unity of human body and spirit, that is, "body and spirit are unified". Body and spirit can be examined from the physiological field. Fu Qingzhu's Gynecology says: "The meridians are based on the kidneys, and the blood flowing from the five internal organs and six bowels all returns to it." Traditional Chinese medicine believes that POI is mostly treated from the kidneys and is related to the five internal organs. Therefore, the physiological field initially constructed by the present invention is based on the theory of internal organs, with the kidney as the main body and the five internal organs as the related ones, such as Figure 2As shown, with the functions of different internal organs and their pathological changes and clinical manifestations as the core, 8 aspects are set up, including menstruation, leucorrhea, fertility, physical symptoms, sleep, bowel movements, diet, and complexion.

[0065] The POI quality of life scale generation method provided by the present invention constructs a POI quality of life scale through eight aspects, namely, menstruation, leucorrhea, fertility, physical symptoms, sleep, defecation, diet, and complexion, so that the scale can accurately evaluate POI patients, thereby further improving the evaluation accuracy of the scale.

[0066] Furthermore, the construction of the psychological domain framework includes: taking the seven emotions and the functions of the five internal organs physiologically transforming each other and pathologically influencing each other as the core, screening out seven aspects related to the psychological domain: joy, anger, worry, thinking, sadness, fear, and shock.

[0067] Specifically, "the seven emotions are related" is an important theory of TCM on the changes of emotions. The seven emotions refer to joy, anger, worry, thought, sadness, fear, and shock. Under normal circumstances, the seven emotions belong to normal physiological activities, but when they change drastically and exceed the normal physiological range that the human body can bear, they will cause diseases. The seven emotions and the functions of the five internal organs are mutually generated physiologically and affect each other pathologically. Therefore, the seven emotions are taken as an evaluation field and included in the scale evaluation range, that is, the psychological field, to evaluate the positive and negative emotions brought by the disease to POI patients.

[0068] The POI quality of life scale generation method provided by the present invention constructs a POI quality of life scale through seven aspects, namely, joy, anger, worry, thought, sadness, fear, and shock, so that the scale can accurately evaluate POI patients, thereby further improving the evaluation accuracy of the scale.

[0069] Furthermore, the construction of the social field framework includes: taking the unity of man, nature and social environment as the core, screening out three aspects related to the social field: social relations, daily life and work, and medical care.

[0070] Specifically, "Lingshu Xieke" says "man corresponds to heaven and earth". "Heaven and man correspond" means "the unity of heaven and man", which reflects the unity of man and nature and social environment. "The Yellow Emperor's Classic of Internal Medicine" also proposes that people have natural social attributes, "Anyone who has not been diagnosed must be asked whether he has been rich and then poor. Although he is not possessed by evil spirits, the disease is caused by internal factors, which is called loss of vitality. Being rich and then poor is called loss of essence. The five qi linger, and the disease is accompanied by something". POI is a chronic disease with complex causes. The physiological and psychological problems it brings also affect the social functions of patients, such as affecting work progress due to memory loss or difficulty in concentrating, affecting normal social interactions due to irritability, depression or depression, affecting husband and wife and family relationships due to decreased fertility, and increasing economic burden due to long-term medical treatment, all of which affect the quality of life of patients. Therefore, the present invention sets the social field as social relations, daily life and work, and medical aspects.

[0071] The POI quality of life scale generation method provided by the present invention constructs a POI quality of life scale through three aspects, namely social relations, daily life and work, and medical treatment, so that the scale can accurately evaluate POI patients, thereby further improving the evaluation accuracy of the scale.

[0072] Step 2: Based on the physiological domain framework, psychological domain framework, and social domain framework, extract quality of life items with characteristics of traditional Chinese medicine to form an original quality of life item pool.

[0073] Specifically, the method of forming the original quality of life item pool of the present invention is: according to literature analysis, medical record review, and patient interviews, items related to the physiological domain framework, psychological domain framework, and social domain framework are respectively extracted to form the original quality of life item pool. Among them, the items related to the physiological domain framework, psychological domain framework, and social domain framework are related sentences or words with characteristics of traditional Chinese medicine.

[0074] Among them, extracting relevant items based on literature analysis includes: conducting literature analysis through China National Knowledge Infrastructure, Weipu Journal Resource Integration Service Platform, Wanfang Database, PubMed, etc. to extract descriptive sentences in the physiological field, psychological field, social field, etc. related to QoL, especially relevant sentences or words with the characteristics of traditional Chinese medicine, and summarizing and listing relevant items; extracting relevant items based on medical record review includes: reviewing medical records by searching the inpatient and outpatient medical record systems of traditional Chinese medicine hospitals to extract relevant items; extracting relevant items based on patient interviews includes: combining the information collected from case reviews, and randomly selecting 10 POI patients in outpatient clinics and wards for semi-structured interviews according to the patients' wishes, to extract relevant sentences or words with the characteristics of traditional Chinese medicine. The present invention extracts an original quality of life item pool containing 146 items in total through these three methods.

[0075] Step three: Optimize and screen the items in the original quality of life item pool to obtain a target quality of life item pool.

[0076] Specifically, the optimization of the items in the original quality of life item pool includes: merging items with similar meanings in the original quality of life item pool; screening the items in the original quality of life item pool includes: deleting items whose correlation with the quality of life of POI patients is lower than the preset value. Finally, the original quality of life item pool was optimized and screened to obtain the target quality of life item pool. The target quality of life item pool includes 3 areas (physiological, psychological, and social), 17 aspects (menstruation, leucorrhea, fertility, physical symptoms, sleep, bowel movements, diet, complexion, joy, anger, worry (sadness), thinking, fear, shock, social relations, daily life and work, and medical treatment), 25 items, and 2 overall evaluations.

[0077] The POI quality of life scale generation method provided by the present invention optimizes and screens the items in the original quality of life item pool, so that the efficiency of evaluating POI patients by the scale composed of the generated target quality of life item pool is effectively improved.

[0078] Step 4: Use the Delphi expert consultation method to further optimize the items in the target quality of life item pool, and generate the POI quality of life initial scale based on the optimized target quality of life items.

[0079] Specifically, the present invention uses two rounds of Delphi expert consultation method to screen the items in the target quality of life item pool. Among them, the experts participating in the Delphi expert consultation method include: 15 experts from 9 provinces or municipalities directly under the Central Government, with wide regional representation, experts involved in three fields of gynecological clinic, gynecological nursing, and scale development, with strong professionalism, and clinical gynecology experts are all associate senior titles or above, with long years of work experience, most experts have more research on POI, and have certain subject representativeness and authority in this field. At the same time, the 15 experts are all medical staff who have been engaged in clinical work of traditional Chinese medicine or traditional Chinese and Western medicine for a long time. The characteristics of traditional Chinese medicine can also be effectively maintained during the Delphi expert consultation process, for example: including the screening, addition and deletion of traditional Chinese medicine connotation items and the improvement and optimization of the popularization of traditional Chinese medicine terminology, thereby ensuring the consistency of the characteristics of traditional Chinese medicine during the development of the scale.

[0080] The method for generating the POI quality of life initial scale of the present invention is described in detail below, which includes the following steps:

[0081] Step 41: Using the results of the first round of Delphi expert consultation, delete 2 items in the target quality of life item pool and add 2 items; at the same time, refine and modify some of the original items to obtain the first round of optimized item pool; among them, the 2 deleted items are: abnormal vaginal discharge and complexion; the 2 new items are: actively understand and find treatment options and confidence in treatment. After the first round of Delphi expert consultation, the first round of optimized item pool includes 38 items and 2 overall evaluations.

[0082] Specifically, the results of the expert consultation were screened according to the importance of the items and the opinions of the experts. In the first round of Delphi expert consultation, two items (abnormal vaginal discharge and complexion) were deleted and two new items (M2 actively understands and seeks treatment options and M3 confidence in treatment) were added. At the same time, the eight items were split into 21 items and 11 items were modified (items with inappropriate expressions and their answer options were modified in combination with the opinions of the experts, and the meaning of the items remained unchanged). A total of 38 items and two overall evaluations entered the second round of expert consultation. The results of the first round of expert consultation are shown in Table 1.

[0083] Table 1 Results of the first round of expert consultation

[0084]

[0085]

[0086] Note: F refers to aspects; P refers to items in the physiological field; M refers to items in the psychological field; S refers to items in the social field; T refers to overall evaluation.

[0087] The specific split of the entries is:

[0088] 1. Divide menstrual abnormalities into: P1 menstrual cycle, P2 menstrual period, P3 menstrual volume;

[0089] 2. Divide the fertility decline into: P4 difficulty in getting pregnant, P5 spontaneous abortion;

[0090] 3. Split hot flashes and sweating into: P6 hot flashes and P7 sweating;

[0091] 4. Split the back and leg pain into: P8 back pain, P9 muscle and joint pain;

[0092] 5. The symptoms of autonomic dysfunction were divided into: P10 palpitations, P11 chest tightness, P12 fatigue, P19 memory loss or forgetfulness;

[0093] 6. Urogenital tract symptoms were divided into: P13 frequent urination and urgency, P14 nocturia, P15 vulvar itching or burning sensation, P16 vaginal dryness and scanty vaginal discharge;

[0094] 7. Sexual discomfort was divided into: P17 decreased or loss of sexual desire, P18 dryness or pain during sexual intercourse;

[0095] 8. Divide abnormal stool into: P21 constipation and P22 diarrhea.

[0096] New additions to the items include: M2 actively learning about and seeking treatment options, and M3 confidence in treatment.

[0097] Step 42: Using the results of the second round of Delphi expert consultation, some items in the first round of optimized item pool were deleted, and some items were modified, and finally the POI quality of life initial scale was generated using the modified items. The POI quality of life initial scale includes 31 items and 2 overall evaluations.

[0098] Specifically, the second round of Delphi expert consultation deleted 7 items and modified 9 items (the question format and word order were modified, but the meaning of the items remained unchanged). The modified item pool had a total of 31 items and 2 overall evaluations, which ultimately generated the POI quality of life initial scale (see Table 2).

[0099] Table 2 Results of the second round of expert consultation

[0100]

[0101]

[0102] Note: F refers to aspects; P refers to items in the physiological field; M refers to items in the psychological field; S refers to items in the social field; T refers to overall evaluation.

[0103] The POI quality of life scale generation method provided by the present invention optimizes the target quality of life item pool by successively adopting two rounds of Delphi expert consultation method, so that the meaning of each item in the optimized scale can be correctly understood and the options can be selected, thereby further improving the accuracy of the quality of life of POI patients.

[0104] Step 5: Optimize the POI quality of life initial scale to obtain the optimized POI quality of life initial scale.

[0105] Specifically, the specific measures for optimizing the POI quality of life initial scale of the present invention include the following steps:

[0106] Step 51: Select a number of patients who meet the POI diagnostic criteria and a corresponding number of healthy people, and conduct a language test on the POI quality of life initial scale to obtain the time for completing the POI quality of life initial scale and the problems encountered in the process of filling in the initial scale.

[0107] Specifically, 10 patients with medium education who met the diagnostic criteria for POI and 10 healthy people were selected for language testing. The time taken by the subjects to complete the scale was calculated, and the problems encountered during the scale filling process were collected to evaluate the comprehensibility and applicability of the items. Among them, the problems encountered during the scale filling process may include: items that may be ambiguous and options that are difficult to check. Since the feasibility of the scale can be reflected by the time taken to fill in the scale, if some subjects take too long to fill in the scale, it indicates that it is not easy to fill in the scale. Therefore, after the scale is filled in, the subjects are asked what is the reason for the long filling time? Which item needs to be entangled or difficult to fill in? Then, the items are further modified according to the feedback of the subjects, so that the meaning of the modified items can be correctly understood, so as to accurately evaluate the quality of life of the patients. The items that may be ambiguous and the options that are difficult to check will also prolong the time to fill in the scale, and more importantly, it is impossible to accurately evaluate the quality of life of the patients. Therefore, these problems need to be paid attention to in order to improve the items.

[0108] Step 52: According to the time of completing the scale and the existing problems, the items in the POI quality of life initial scale are optimized by adjusting the questioning method and modifying the item options without changing the meaning of the items, thereby obtaining the optimized POI quality of life initial scale.

[0109] Specifically, the present invention combines the degree of understanding and suggestions of the subjects, and after repeated discussions by the core group, modifies and optimizes the content and options of some items in the POI quality of life initial scale, adjusts the questioning method and modifies the item options without changing the meaning of the item, so that the item sentences are smoother and the understanding is more accurate; and asks the subjects who raise questions or suggestions to fill in again until the subjects and researchers reach a consensus on the understanding of the items, and finally compiles it into the Chinese POIQOL scale, that is, the optimized POI quality of life initial scale.

[0110] Step 6: Testing the optimized POI quality of life scale by investigating the research subjects, and determining the final POI quality of life scale based on the test results.

[0111] The following is a detailed description of how to generate the final POI quality of life scale, which includes the following steps:

[0112] Step 61: Selecting research subjects and grouping the research subjects into a POI group, a POI retest group, a POI+WHO group, and a healthy control group. The research subjects include: a POI group and a healthy group;

[0113] Specifically, the subjects of the survey and research were POI patients and healthy people in the outpatient or inpatient clinics of a Chinese medicine affiliated hospital. Before grouping the subjects of the survey and research, the diagnostic criteria and inclusion and exclusion criteria of the POI group and the healthy group must be determined first. Among them, the diagnostic criteria of the POI group are:

[0114] The diagnostic criteria for the POI group were jointly formulated with reference to the POI diagnosis and treatment guidelines published by the European Society of Human Reproduction and Embryology (ESHRE) in January 2016, the POI Chinese expert consensus in September 2017, the POI integrated traditional Chinese and Western medicine diagnosis and treatment guidelines in 2022, and the clinical diagnosis and treatment expert consensus of premature ovarian insufficiency in 2023: (1) age <40 years; (2) prolonged menstrual cycle, irregular cycle, decreased menstrual flow, oligomenorrhea to amenorrhea for at least 4 months; (3) serum FSH>25 IU / L for at least 2 times (tested on the 2nd to 4th day of the menstrual cycle, or at the time of amenorrhea, with an interval of 4 weeks between the 2 tests). All three of the above items must be met at the same time.

[0115] The inclusion criteria for the POI group were:

[0116] (1) 18 years old and below 40 years old; (2) meet the diagnostic criteria of this disease; (3) voluntarily participate in this study.

[0117] The exclusion criteria for the POI group were:

[0118] (1) Patients who do not meet the inclusion criteria. (2) Patients with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system diseases and mental illness. (3) Patients with organic diseases of the reproductive system and menstrual disorders caused by other endocrine factors (such as hyperprolactinemia, polycystic ovary syndrome, etc.) are excluded. (4) Pregnant and lactating women.

[0119] The inclusion criteria for the healthy group were:

[0120] (1) Women aged 18 to 40 years. (2) Regular menstruation (normal menstrual cycle, menstrual period, and menstrual volume), without organic lesions of the ovary or uterus. (3) No history of acute or chronic diseases, or those who have been cured of acute or chronic diseases and have no special discomfort at this stage. (4) Informed about this study and willing to participate in this study.

[0121] The exclusion criteria for the healthy group were:

[0122] (1) Do not meet the inclusion criteria; (2) Pregnant or lactating women.

[0123] In addition, the total number of subjects in the survey is ≥ 5 times the number of items, and the total number shall not be less than 100. Because the prevalence of POI is about 1-4% and there are relatively few clinical patients, the sample size (i.e. the total number of survey subjects) is intended to be 5 times the number of items. Taking the optimized POI quality of life initial scale as an example, it includes 31 items + 2 overall evaluations. Therefore, the estimated total sample size is not less than 155 cases. Since the role of the healthy group is to evaluate the discrimination, as long as the number of people in the POI group is greater than that in the healthy group, the ratio can be: 2:1 or 3:1.

[0124] The following is an introduction to the POI group, POI retest group, POI+WHO group, and healthy control group after grouping:

[0125] (1) POI Group: Fill out the General Situation Questionnaire and the Chinese POIQOL Scale (preliminary version), record the time taken to complete the questionnaire, and record in detail any areas of misunderstanding or questions that the respondents had about the questionnaire.

[0126] ① POI retest group: 30 POI patients were randomly selected from the POI group and retested with the General Situation Survey Scale and the Chinese POIQOL Scale 24 hours after the initial test;

[0127] ②POI+WHO group: 50 POI patients were randomly selected from the POI group and filled in the general situation survey scale, the Chinese POIQOL scale, and the World Health Organization Quality of Life Measurement Scale Brief Form (WHOQOL-BREF) on the day of consultation.

[0128] (2) Healthy control group: Fill out the general situation questionnaire and the Chinese POIQOL scale (preliminary version).

[0129] Step 62: Performing a scale test on the POI group, the POI retest group, the POI+WHO group, and the healthy control group, respectively, to obtain a score corresponding to each item in the scale.

[0130] Specifically, since some subjects fill in paper questionnaires and some subjects fill in electronic questionnaires in the process of filling in the scale, the present invention collects the data of paper questionnaires and electronic questionnaires in a unified manner. Among them, in the items of the scale, the overall evaluation T2 health status self-rating score is set as a linear item, which is scored from 0 to 10 points, and each of the remaining item options is assigned 1-5 points according to the Likert five-point equal interval scoring method. The higher the domain and total score in the scale, the better the patient's quality of life. For patients with no sex life, no fertility requirements or other conditions, some items are set with the option of "not related to me" and are uniformly assigned 3 points. Finally, SPSS25.0 software and AMOS27.0 software were used to perform statistical analysis on the collected questionnaire data to obtain the score of each item.

[0131] Step 63: Perform statistical analysis based on the score of each item, and determine the final POI QOL scale based on the analysis results.

[0132] Specifically, in the embodiment of the present invention, a total of 175 questionnaires were collected, with a recovery rate and completion rate of 100%, and an average answering time of 5-8 minutes. Among them, 115 POI patients and 60 healthy people were excluded, and 5 questionnaires that did not meet the POI exclusion criteria were finally included in 170 questionnaires, including 110 POI patients and 60 healthy people. According to the research method of scale item screening, the present invention adopts 4 or more selected items in 6 methods including frequency distribution method, discrete trend method, Cronbach's coefficient method, correlation analysis method, factor analysis method, and discrimination analysis method, and combines the opinions of the subject group to finally produce representative, independent, sensitive, and relatively important items (see Table 3), and re-sort the items in Table 3, and finally form the final scale of the present invention, that is, the final POIQOL scale, which includes 3 fields, 11 aspects, 30 items + 2 overall evaluations (see Table 4).

[0133] Table 3 Screening results of items in the Chinese premature ovarian insufficiency quality of life scale

[0134]

[0135]

[0136] Table 4 Final scale of the Chinese premature ovarian insufficiency quality of life scale

[0137]

[0138]

[0139] Step 7: Evaluate the reliability, validity, discrimination and feasibility of the final POI quality of life scale.

[0140] Specifically, the final POI quality of life scale generated by the present invention is evaluated below, and its evaluation criteria include: reliability assessment, validity assessment, structural validity, discrimination assessment, and feasibility analysis. Among them, the reliability assessment includes: internal consistency reliability, split-half reliability, and test-retest reliability. The validity assessment includes: content validity, criterion-related validity, and structural validity, among which the structural validity includes: exploratory factor analysis and confirmatory factor analysis.

[0141] Internal consistency reliability

[0142] The Cronbach's coefficient is greater than 0.7, indicating good internal consistency. The results show that the total Cronbach's coefficient of the scale generated by the method provided by the present invention is 0.910, indicating good internal consistency. The Cronbach's coefficients in the physiological, psychological, and social fields are 0.813, 0.821, and 0.763, respectively, all exceeding 0.7, indicating that the scale generated by the present invention also has good internal consistency in various fields.

[0143] Split-half reliability

[0144] The split-half reliability test represents the consistency of the scale across items. A split-half coefficient greater than 0.7 indicates good reliability. The results show that the correlation coefficient of the two subscales is 0.916 and the split-half coefficient is 0.956, indicating that the split-half reliability of the scale is good.

[0145] Test-Retest Reliability

[0146] 30 POI patients were randomly selected and retested 24 hours after filling out the Chinese POIQOL scale for the first time. The age of the 30 POI retest group patients was 33.87±4.89 years old, which was basically consistent with the age of the 110 POI patients in the total sample of 34.63±4.43 years old, with a P value of >0.05, and there was no statistical difference between the two. The data followed a normal distribution, so the Pearson correlation coefficient method was used to analyze the correlation between the total score of the scale and the scores of each domain between the two measurements. The results showed that the correlation coefficient of the total score of the scale for the two evaluations was 0.868, which was greater than 0.7, indicating that the results were relatively stable and consistent, and the retest reliability was good.

[0147] Content validity

[0148] Content validity refers to the extent to which the items contained in the scale can represent the content to be measured. In the early stage of the present invention, a large number of relevant domestic and foreign literature were consulted by literature analysis, and the development methods and contents of domestic and foreign QoL scales and scales related to POI were referred to. The item pool was improved by combining the medical record review method and the patient interview method, and the Delphi expert consultation method was used to screen the items. After repeated discussions and revisions by the project working group, the language test was conducted through a preliminary survey, and finally the POI quality of life scale was formed, so that the scale is easy to be understood and filled in by POI patients, and the representativeness is good, so it can be considered that the scale has good content validity. At the same time, the present invention uses the correlation analysis method to evaluate the correlation between the scores of each field of the scale and the total score. The results show that the scores of each field of the scale are strongly correlated with the total score, with a correlation coefficient of >0.7, among which the physiological field has the strongest correlation with the total score, with a correlation coefficient of 0.913, and it can be considered that the content validity of this scale is good. The correlation coefficient results of each field and the total scale are shown in Table 5.

[0149] Table 5 Correlation coefficient results of each field and the total scale

[0150]

[0151] Note: **The correlation is significant at the 0.01 level (two-tailed).

[0152] Criterion-Related Validity

[0153] Criterion-related validity refers to the degree of consistency between the scale score and an external criterion, that is, the degree of effectiveness and accuracy of the measurement results in representing or predicting the behavior of the criterion. Since there is no gold standard for evaluating the QoL of POI patients, the present invention uses the universal scale commonly used in clinical evaluation of QoL-WHOQOL-BREF as the criterion, measures 50 patients in the POI+WHO group, and conducts correlation analysis to test the criterion-related validity of this scale. The results showed that the age of 50 patients in the POI+WHO group was 35.10±4.10 years old, which was basically consistent with the age of 110 patients in the total POI sample of 34.63±4.43 years old, with a P value of >0.05, and there was no statistical difference between the two. The correlation coefficient of the total scores of the two scales in the POI+WHO group was 0.817, and the correlation coefficient was >0.7, which had a strong correlation, indicating that the POI quality of life scale generated by the method of the present invention has a strong criterion-related validity.

[0154] Construct validity--exploratory factor analysis

[0155] The KMO value of the 30 items in this scale was 0.773, and Bartlett's test P < 0.05, indicating that the data are suitable for factor analysis. The results showed that the scale extracted 9 factors with characteristic roots > 1, and the cumulative variance contribution rate was 71.063%, which was greater than 50%, indicating that the POI quality of life scale generated by the method of the present invention has good structural validity (see Table 6).

[0156] Table 6 Total variance explained results

[0157]

[0158]

[0159] Construct validity--confirmatory factor analysis

[0160] The embodiment of the present invention uses AMOS27.0 software to perform confirmatory factor analysis to evaluate the model fit. When the comparative fit index (CFI), goodness-of-fit index (GFI), and tucker-lewis index (TLI) are all greater than 0.900, the root mean square error of approximation (RMSEA) is less than 0.080, the residual mean root (RMR) is less than 0.100, and the chi-square freedom ratio (χ2 / df) is less than 3.000, it indicates that the model fit is ideal, that is, it has good structural validity. The results suggest that the model fit of the scale generated by the method of the present invention is ideal and has good structural validity. The basic parameters of the confirmatory factor analysis are shown in Table 7.

[0161] Table 7 Results of confirmatory factor analysis of the scale

[0162]

[0163] Discrimination test

[0164] The general data of 110 POI patients and 60 healthy people were compared, and the P values ​​of each item were greater than 0.05, with no statistical difference. The scale results of 110 POI patients and 60 healthy people showed that in the comparison of the total score and the scores in the three areas of physiology, psychology, and society, the P values ​​were all less than 0.01, and the differences were statistically significant, indicating that the scale generated by the present invention has the ability to distinguish people with different attributes, and the discrimination is good (see Table 8).

[0165] Table 8 Results of differentiation between POI patients and healthy people

[0166]

[0167]

[0168] Note: P<0.05, the difference between the two groups is statistically significant

[0169] Feasibility Analysis

[0170] To determine whether a scale has good feasibility, the recovery rate, completion rate and answering time of the scale are usually used to measure it. Generally, the recovery rate and completion rate of the scale are required to be above 80%, and the answering time is more appropriate within 20 minutes. Since the scale generated by the present invention is filled in on-site or online questionnaires, the recovery rate and completion rate of the scale are 100%, and the time recorded by the online questionnaire to complete the scale is within 5-8 minutes on average, so the scale generated by the present invention has good feasibility.

[0171] Figure 3 The structure diagram of the device for generating the quality of life scale provided by the present invention is as follows: Figure 3 As shown, the device comprises:

[0172] A construction unit is used to construct a theoretical framework of the POI quality of life scale based on traditional Chinese medicine; the theoretical framework includes: a physiological domain framework, a psychological domain framework, and a social domain framework;

[0173] An extraction unit, used to extract quality of life items with characteristics of traditional Chinese medicine according to the physiological domain framework, the psychological domain framework, and the social domain framework, to form an original quality of life item pool;

[0174] A processing unit, configured to optimize and screen the items in the original quality of life item pool to obtain a target quality of life item pool;

[0175] An optimization unit, used to optimize the items in the target quality of life item pool again by using the Delphi expert consultation method, and generate an initial POI quality of life scale according to the optimized target quality of life items;

[0176] The optimization unit is further used to optimize the POI initial quality of life scale to obtain an optimized POI initial quality of life scale;

[0177] A testing unit, used for testing the optimized POI quality of life initial scale by investigating research subjects;

[0178] A determination unit, used for determining a final POI quality of life scale according to the test results;

[0179] The evaluation unit is used to evaluate the reliability, validity, discrimination and feasibility of the final POI quality of life scale.

[0180] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for generating a POI quality of life scale, characterized in that: include: Step 1: Construct the theoretical framework of the POI quality of life scale based on the theory of traditional Chinese medicine; The theoretical framework includes: physiological domain framework, psychological domain framework, and social domain framework; Step 2: Extracting quality of life items with TCM characteristics based on the physiological domain framework, psychological domain framework, and social domain framework to form an original quality of life item pool; Step 3: Optimizing and screening the items in the original quality of life item pool to obtain a target quality of life item pool; Step 4: Using the Delphi expert consultation method, the items in the target quality of life item pool are optimized again, and the POI quality of life initial scale is generated based on the optimized target quality of life items; Step 5: Optimizing the POI quality of life initial scale to obtain an optimized POI quality of life initial scale; Step 6: testing the optimized POI quality of life scale by investigating the research subjects, and determining the final POI quality of life scale based on the test results; Step 7: Evaluate the reliability, validity, discrimination and feasibility of the final POI quality of life scale.

2. The method for generating a POI quality of life scale according to claim 1, characterized in that: In step 1, the construction of the physiological domain framework includes: Taking the kidney as the main factor and the five internal organs as the related factors, the functions of different internal organs and their pathological changes and clinical manifestations as the core, eight aspects related to the physiological field were screened out, namely: menstruation, leucorrhea, fertility, physical symptoms, sleep, defecation, diet, and complexion; The construction of the psychological domain framework includes: With the seven emotions and the functions of the five internal organs interacting physiologically and influencing each other pathologically as the core, seven aspects related to the psychological field were selected: joy, anger, worry, thinking, sadness, fear, and shock; The construction of the social domain framework includes: Taking the unity of man, nature and social environment as the core, three aspects related to the social field are selected: social relations, daily life and work, and medical care.

3. The method for generating a POI quality of life scale according to claim 1 or 2, characterized in that: The second step comprises: By using literature analysis, medical record review, and patient interviews, we extracted items related to the physiological domain framework, psychological domain framework, and social domain framework to form the original quality of life item pool; The entries corresponding to the physiological domain framework, the psychological domain framework, and the social domain framework are relevant sentences or words with characteristics of traditional Chinese medicine.

4. The method for generating a POI quality of life scale according to claim 3, characterized in that: The step three comprises: The target quality of life item pool is obtained by merging items with similar meanings in the original quality of life item pool and deleting items whose correlation with the quality of life of POI patients is lower than a preset value.

5. The method for generating a POI quality of life scale according to claim 3, characterized in that: The fourth step comprises: Step 41: Using the results of the first round of Delphi expert consultation, delete 2 items in the target quality of life item pool and add 2 new items; at the same time, refine and modify some of the original items to obtain the first round of optimized item pool; among them, the 2 deleted items are: abnormal vaginal discharge and complexion; the 2 new items are: actively understanding and seeking treatment options and confidence in treatment; the first round of optimized item pool includes: 38 items and 2 overall evaluations; Step 42: using the results of the second round of Delphi expert consultation, deleting some items in the first round of optimized item pool, and modifying some items, and finally generating the POI quality of life initial scale; The POI quality of life initial scale includes 31 items and 2 overall evaluations.

6. The method for generating a POI quality of life scale according to claim 3, characterized in that: The step five comprises: Step 51: Select a number of patients who meet the POI diagnostic criteria and a corresponding number of healthy people, and conduct a language test on the POI quality of life initial scale to obtain the time to complete the POI quality of life initial scale and the problems encountered in the process of filling in the initial scale; Step 52: According to the time of completing the scale and the existing problems, the items in the POI quality of life initial scale are optimized by adjusting the questions and modifying the item options without changing the meaning of the items, thereby obtaining the optimized POI quality of life initial scale.

7. The method for generating a POI quality of life scale according to claim 3, characterized in that: The step six comprises: Step 61: Selecting research subjects, and grouping the research subjects into a POI group, a POI retest group, a POI+WHO group, and a healthy control group; the research subjects include a POI group and a healthy group; Step 62: Performing a scale test on the POI group, the POI retest group, the POI+WHO group, and the healthy control group, respectively, to obtain a score corresponding to each item in the scale; Step 63: Perform statistical analysis based on the score of each item, and determine the final POI QOL scale based on the analysis results.

8. The method for generating a POI quality of life scale according to claim 7, characterized in that: The step 62 comprises: The POI group performs preliminary tests on the general situation survey scale and the optimized POI quality of life initial scale to obtain the scores corresponding to each item in the corresponding scale; and records the time of filling in the general situation survey scale and the target POI quality of life scale, as well as the areas where the respondents do not understand or have questions about the target POI quality of life scale during the filling process; The POI retest group retests the general situation survey scale and the optimized POI initial quality of life scale within 24 hours of the initial test to obtain the scores corresponding to each item in the corresponding scale; the POI retest group is a retest group composed of a number of POI retest patients randomly selected from the POI group; The POI+WHO group was tested on the day of consultation on the general situation survey scale, the optimized POI initial quality of life scale, and the World Health Organization quality of life measurement scale brief form to obtain the scores corresponding to each item in the corresponding scales; the POI+WHO group was a patient group composed of several patients randomly selected from the POI group; The general situation questionnaire and the optimized POI quality of life initial scale were respectively tested by the healthy group to obtain the scores corresponding to each item in the corresponding scale.

9. The method for generating a POI quality of life scale according to claim 7, characterized in that: The step 63 comprises: The scores of all items were statistically analyzed using four or more of the frequency distribution method, discrete trend method, Cronbach's coefficient method, correlation analysis method, factor analysis method, and discrimination analysis method, and the final POIQOL scale was determined based on the analysis results.

10. A device for executing the method for generating a POI quality of life scale according to any one of claims 1 to 9, characterized in that: include: Construction unit, used to construct the theoretical framework of POI quality of life scale based on traditional Chinese medicine; The theoretical framework includes: physiological domain framework, psychological domain framework, and social domain framework; An extraction unit, used to extract quality of life items with characteristics of traditional Chinese medicine according to the physiological domain framework, the psychological domain framework, and the social domain framework, to form an original quality of life item pool; A processing unit, configured to optimize and screen the items in the original quality of life item pool to obtain a target quality of life item pool; An optimization unit, used to optimize the items in the target quality of life item pool again by using the Delphi expert consultation method, and generate an initial POI quality of life scale according to the optimized target quality of life items; The optimization unit is further used to optimize the POI initial quality of life scale to obtain an optimized POI initial quality of life scale; A testing unit, used for testing the optimized POI quality of life initial scale by investigating research subjects; The determination unit is used to determine the final POI quality of life scale according to the test results. The evaluation unit is used to evaluate the reliability, validity, discrimination and feasibility of the final POI quality of life scale.

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