PRO-based biliary tract cancer state scale development and verification system

Abstract

The invention relates to a PRO-based biliary tract cancer state scale development and verification system, which comprises an entry generation module, an entry screening and optimization module, a psychological measurement verification module and a scale output module which are connected in sequence, and all the modules cooperate to complete development and verification of a biliary tract cancer state scale. The Bi-SA scale developed by the invention is specially designed for biliary tract cancer patients, 10 BTC patient core symptoms such as pain, abdominal distension and appetite decline are screened out through literature review and multidisciplinary expert consensus, the defects of existing EORTCQLQ-BIL21 and FACT-Hep are overcome, the symptom burden of BTC patients can be accurately reflected, the Bi-SA scale generated through a standardized process can accurately reflect the BTC patient's symptoms, and the BTC patient's symptoms can be accurately determined. The kit has the advantages of being high in specificity, excellent in metrology property, flexible and practical, can effectively fill the blank of specific PRO tools for the biliary tract cancer, provides important support for clinical symptom management, treatment decision and prognosis evaluation, and has wide clinical application prospects.

Description

Technical Field

[0001] This invention relates to the field of medical and health assessment technology, specifically to a PRO-based biliary tract cancer symptom scale development and validation system. Background Technology

[0002] Biliary tract cancers (BTCs) encompass gallbladder cancer and cholangiocarcinomas (CCAs), with cholangiocarcinomas further divided into intrahepatic cholangiocarcinoma (ICC) and extrahepatic cholangiocarcinoma (ECC). Although BTCs account for less than 1% of all malignant tumors, they are second only to hepatocellular carcinoma (HCC) among primary liver cancers, accounting for approximately 10%-15% of all primary liver cancers. Statistics show that there are approximately 52,800 new cases of biliary tract malignancies and 40,700 deaths annually in China.

[0003] BTC (cancer-related cancers) have an insidious onset, and most patients are diagnosed at an advanced stage, resulting in a low rate of patients eligible for radical surgery. Systemic therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, and various combination regimens) has become the standard treatment for advanced BTC. BTC patients often experience both systemic and local effects of the disease, with common symptoms including jaundice, abdominal pain, itching, nausea, involuntary weight loss, fever, and fatigue. Early and effective symptom management is crucial for improving patients' quality of life and reducing mortality, especially for cancer patients nearing the end of their lives, where symptom control and functional status are particularly critical.

[0004] Patient-reported outcomes (PROs), derived directly from patients and without interpretation by physicians or others, are more sensitive to potential changes in functional status and can more promptly reflect early symptoms during treatment compared to physician reports. However, validated PRO tools for BTC patients are currently scarce. Existing questionnaires for assessing the quality of life of BTC patients, such as the European Organization for Research and Treatment of Cancer (EORTCQLQ-BIL21), primarily focus on quality of life assessment rather than specific symptoms; while the Functional Assessment of Cancer Treatment-Hepatobiliary Version (FACT-Hep) is suitable for assessing the quality of life of liver and pancreatic cancer patients, it has weak specificity for BTC and cannot meet the clinical need for accurate and dynamic assessment of BTC patient symptoms, let alone achieve the "monitoring-early warning" goals of in-hospital and out-of-hospital management. Therefore, developing a PRO tool specifically designed to measure the symptom burden of BTC patients with specificity, sensitivity, and feasibility has become an urgent need in the current clinical management of biliary tract cancer. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides a PRO-based biliary tract cancer symptom scale development and validation system. This system overcomes the deficiencies of existing biliary tract cancer symptom assessment tools, which lack specificity and are unable to meet the clinical "monitoring-early warning" needs. Through a standardized development process and a rigorous validation mechanism, it generates a scale tool that can accurately assess the symptom burden of BTC patients, providing reliable support for clinical symptom management.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a PRO-based biliary tract cancer symptom scale development and validation system, comprising an item generation module, an item screening and optimization module, a psychometric validation module, and a scale output module connected in sequence, wherein each module works together to complete the development and validation of the biliary tract cancer symptom scale; The entry generation module constructs an initial symptom entry library through a literature review; The item screening and optimization module uses the Delphi method combined with item score distribution analysis to screen core symptom items; The psychometric verification module uses classical testing theory and item response theory to verify the scale's characteristics. The scale output module generates the final biliary tract cancer symptom assessment scale.

[0007] Furthermore, the process of constructing the initial symptom entry library by the entry generation module includes: setting a search deadline, selecting WebofScience, PubMed, VIP, Wanfang, and CNKI Chinese and English databases as search sources; performing a system search using "gallbladder cancer symptoms," "bile duct cancer symptoms," and "biliary tract tumor symptomology" as search keywords; having two independent reviewers screen the literature titles and abstracts, with senior researchers making the final decision in case of disagreement; conducting a full-text review of the approved literature, with the two reviewers independently extracting symptom data, and senior researchers coordinating to reach a consensus in case of discrepancies, thus integrating and forming an initial symptom entry library containing 23 symptom entries.

[0008] Furthermore, the item filtering and optimization module includes a Delphi method filtering unit and an item reduction unit; The Delphi method screening unit comprised a multidisciplinary team of 33 experts covering oncology, hepatobiliary surgery, clinical epidemiology, and psychology. Two rounds of Delphi questionnaires were designed. The first round included item descriptions, basic expert information, initial symptom items (5-point Likert scale score), open-ended suggestions, and expert self-assessment. The second round added the results of the previous round of consultations, a summary of professional opinions, and feedback from the research team. Questionnaires were distributed via a combination of email and paper questionnaires. In the first round, 25 questionnaires were distributed and 23 were returned (92.00% response rate). In the second round, 33 questionnaires were distributed and 32 were returned (96.97% response rate). Expert authority and coordination coefficients were calculated, and 18 candidate symptom items with scores ≥4 were selected.

[0009] Furthermore, the operation process of the item deletion unit is as follows: 175 patients with biliary tract cancer were included, and 18 candidate symptom items were scored using the 0-10 numerical rating scale (NRS); the score distribution of each item was analyzed, and the mean, standard deviation, missing rate and floor effect were calculated. Items with a floor effect of less than 80% were screened; similar or redundant items were identified using hierarchical cluster analysis, and 8 items including low back pain, jaundice, back pain, fever, diarrhea, shoulder pain, rash, and chills were deleted based on clinical significance, leaving 10 core symptom items.

[0010] Furthermore, the 10 core symptom items are pain, abdominal distension, decreased appetite, nausea, aversion to oily foods, sleep disturbances, fatigue, itchy skin, drowsiness, and altered taste.

[0011] Furthermore, the psychometric validation module includes a classical test theory validation unit and an item response theory validation unit. The classical test theory validation unit selected 86 patients with stable biliary tract cancer, who completed the core symptom item scoring for two consecutive days. The test-retest reliability (within-group correlation coefficient) and internal consistency reliability (Cronbach's α coefficient) of the scale were calculated. The results showed that the total Cronbach's α coefficient was 0.79. After deleting any core item, the Cronbach's α coefficient was between 0.74 and 0.79. The test-retest reliability within-group correlation coefficient was 0.77-0.95 (P < 0.001).

[0012] Furthermore, the project response theory validation unit conducted exploratory factor analysis (principal component method) on the scoring data of 175 patients. The applicability of the data was validated by the Kaiser-Meyer-Olkin (KMO) test (KMO value ≥ 0.7) and Bartlett's test of sphericity (p < 0.001). The graded response model (GRM) was used to analyze the discrimination parameter α (0.89-2.92) and difficulty parameter b (0.34-8.22) of the core symptom items to validate the unidimensional structure, discrimination ability and difficulty appropriateness of the questionnaire.

[0013] Furthermore, the Biliary Tract Cancer Symptom Assessment Scale (Bi-SA) generated by the scale output module includes two review time period versions: a review version for the past 24 hours and a review version for the past 7 days. Both versions use the 0-10 numerical rating scale (NRS), with 0 points indicating no symptoms and 10 points indicating the most severe symptoms.

[0014] Furthermore, the scale output module generates paper and electronic versions of the scale, which can be used alone or in combination with other modular assessment tools for dynamic monitoring and assessment of symptoms in patients with biliary tract cancer.

[0015] Compared with the prior art, the technical solution of this application has the following beneficial effects: 1. The Bi-SA scale developed in this invention is specifically designed for patients with biliary tract cancer. Through literature review and multidisciplinary expert consensus, it screens out 10 core symptoms of BTC patients, such as pain, abdominal distension, and decreased appetite. It overcomes the shortcomings of existing EORTCQLQ-BIL21 (which focuses on quality of life) and FACT-Hep (which has weak specificity) and can accurately reflect the symptom burden of BTC patients. 2. This invention is verified by classical test theory. The internal consistency of the scale has a Cronbach's α coefficient > 0.7, and the test-retest reliability within the group has a correlation coefficient of 0.77-0.95, indicating good stability and consistency. Item response theory verification shows that the item discrimination parameter α is between 0.89 and 2.92, and the difficulty parameter b is appropriate, indicating good discrimination ability and accurate identification of patients with different symptom experience levels. 3. This invention supports both paper and electronic versions and can be used alone or in combination with other assessment tools to meet the diverse needs of routine in-hospital assessment and out-of-hospital "monitoring-early warning" and facilitate clinical promotion.

[0016] 4. This invention strictly adheres to the PRO scale development standards recommended by the U.S. Food and Drug Administration (FDA). Through literature review, Delphi method screening, item analysis and reduction, and multidimensional psychometric verification, the scientific and standardized nature of the scale development process is ensured, providing a reliable guarantee for clinical application. Attached Figure Description

[0017] Figure 1 This is a framework diagram of a PRO-based biliary tract cancer symptom scale development and validation system according to the present invention. Figure 2 This is a hierarchical clustering analysis diagram of Bi-SA in this invention; Figure 3 This is a schematic diagram of the 24-hour review period of the Bi-SA method of the present invention; Figure 4 This is a schematic diagram of the 7-day review period of the Bi-SA method of the present invention. Detailed Implementation

[0018] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] Please see Figure 1-4 This embodiment of a PRO-based biliary tract cancer symptom scale development and validation system includes an item generation module, an item screening and optimization module, a psychometric validation module, and a scale output module. These modules are connected in sequence to work together to complete the development and validation of the biliary tract cancer symptom scale. The entry generation module is used to construct an initial symptom entry library through a literature review, specifically including: Set the search deadline and select WebofScience, PubMed, VIP, Wanfang, and CNKI Chinese and English databases as search sources; A system search was performed using keywords such as "gallbladder cancer symptoms," "bile duct cancer symptoms," and "symptomatology of biliary tumors." Two independent reviewers screened the titles and abstracts of the literature; if there was any disagreement, the senior researcher made the final decision. The literature that passed the initial screening underwent a full review, and the literature on symptom research of biliary tract cancer that met the criteria was finally included. Two reviewers independently extracted symptom data from the included literature. If discrepancies arose in the data extraction, a senior researcher coordinated to reach a consensus and integrate the extracted symptom data to form an initial symptom entry library. The initial entry library contained 23 symptom entries, including pain, bloating, decreased appetite, nausea, aversion to oily foods, sleep disturbances, fatigue, itchy skin, abdominal pain, vomiting, diarrhea, chills, yellowing of the skin / eyes, fever, back pain, weight loss, lower back pain, changes in stool color, cold intolerance, skin nodules, cough, and yellow urine.

[0020] The item screening and optimization module uses the Delphi method for expert consensus screening and combines item score distribution analysis for item reduction, specifically including: Delphi method screening unit: A multidisciplinary expert team was formed, comprising 33 experts covering oncology, hepatobiliary surgery, clinical epidemiology, and psychology. The Delphi questionnaire was designed in two rounds. The first round included item descriptions, basic information about the experts, initial symptom items (scored using a 5-point Likert scale, 1 = disagree, 5 = strongly agree), open-ended suggestions, and expert self-assessment (judgment criteria: large / medium / small; familiarity: 5-point Likert scale). The second round added the results of the expert consultation in the first round, a summary of professional opinions, and feedback from the research team's discussion. The questionnaires were distributed via a combination of email and paper questionnaires. In the first round, 25 questionnaires were distributed and 23 were returned, with a response rate of 92.00%. In the second round, 33 questionnaires were distributed and 32 were returned, with a response rate of 96.97%. After each round of questionnaires were collected, the research team analyzed and summarized the expert responses and revised the questionnaires for the next round until the results stabilized. The expert authority and coordination coefficient were calculated. In the first round, the expert familiarity coefficient Cs=0.92, the judgment coefficient Ca=0.94, the authority coefficient Cr=0.93, and the coordination coefficient was 0.504 (P<0.001). In the second round, the expert familiarity coefficient Cs=0.88, the judgment coefficient Ca=0.92, and the coordination coefficient was 0.561 (P<0.001). Based on the expert scoring results, symptom items with scores ≥4 were selected, forming 18 candidate symptom items. Item reduction unit: 175 patients with biliary tract cancer were included. The 0-10 numerical rating scale (NRS) was used to score candidate symptom items, and patient score data were collected. Analyze the score distribution of each symptom item, calculate the mean, standard deviation, missing rate, and floor effect (the proportion of scores concentrated at 0), and screen items with a floor effect of less than 80%. Hierarchical cluster analysis was used to identify similar or redundant entries. Based on clinical significance, eight entries, including lower back pain, jaundice, back pain, fever, diarrhea, shoulder pain, rash, and chills, were deleted. Finally, ten core symptom entries were retained, namely pain, abdominal distension, decreased appetite, nausea, aversion to oily food, sleep disturbance, fatigue, skin itching, drowsiness, and altered taste. The psychometric validation module employs Classical Test Theory (CTT) and Item Response Theory (IRT) for scale validation, specifically including: Classic test theory verification unit: Eighty-six patients with stable biliary tract cancer were selected. They completed the scoring of the core symptom items on two consecutive days. The test-retest reliability (within-class correlation coefficient) and internal consistency reliability (Cronbach's α coefficient) of the scale were calculated. The results showed that the overall Cronbach's α coefficient of the scale was 0.79. After deleting any core symptom item, the Cronbach's α coefficient remained between 0.74 and 0.79, indicating good internal consistency. The intraclass correlation coefficients of the test-retest reliability ranged from 0.77 to 0.95 (P < 0.001), demonstrating excellent scale stability. Project Response Theory Verification Unit: Exploratory factor analysis (principal component method) was performed on the scoring data of 175 patients. The applicability of the data was verified by Kaiser-Meyer-Olkin (KMO) test and Bartlett's test of sphericity. The KMO value ≥ 0.7 and the Bartlett test p < 0.001 indicate that the data are suitable for factor analysis, verifying the unidimensional structure of the scale. The graded response model (GRM) was used to analyze the discrimination parameter α and difficulty parameter b for each core symptom item. The discrimination parameter α ranged from 0.89 to 2.92. Among them, the α values ​​for pain and sleep disturbances were 1.11, bloating was 1.30, nausea was 1.49, taste changes were 1.67, drowsiness was 1.76, fatigue was 2.21, aversion to oily foods was 2.67, and decreased appetite was 2.92, all within the good discrimination range of 0 to +3. The difficulty parameters b1-b10 ranged from 0.34 to 8.22, within the appropriate difficulty range of -4 to +4, thus verifying the scale's discrimination ability and difficulty appropriateness. The scale output module is used to generate the final Biliary Tract Cancer Symptom Assessment Scale (Bi-SA), which specifically includes: Two versions of the scale were designed for different time periods: a 24-hour review version and a 7-day review version. Both versions contain 10 core symptom items and use the 0-10 numerical rating scale (NRS), where 0 indicates no symptoms and 10 indicates the most severe symptoms. Generate paper and electronic versions of the scale, which can be used alone or in combination with other modular assessment tools for the dynamic monitoring and assessment of symptoms in patients with biliary tract cancer.

[0021] Example Item formation and selection: Literature review and Delphi method Step 1: Following the US FDA guidelines [1], we established an initial entry database through a literature review. The search period ended in December 2021, and a systematic search was conducted in multiple Chinese and English databases, including WebofScience, PubMed, VIP, Wanfang, and CNKI, with a focus on symptom studies of gallbladder and bile duct cancer. The topics and abstracts were independently selected by two reviewers (ZJY and ZYX), and if there was any disagreement, the senior researcher made the decision. All included literature underwent full text review. For the studies that were finally included, the symptom data were independently extracted by the two reviewers, and if necessary, the senior researcher coordinated to reach a consensus.

[0022] Step 2: Based on international consensus [2], we adopted the Delphi method [3] to reach a consensus based on the experts' scoring and learning of the previous results. The first round of the Delphi questionnaire included: (1) Project description; (2) Basic information of experts; (3) Possible PRO items, scored using a 5-point Likert scale (1 = Disagree, 5 = Strongly Agree); (4) Open-ended suggestions; (5) Expert self-assessment (judgment criteria: large / medium / small; familiarity: 5-point Likert scale). The second round of the Delphi questionnaire added the following to this: (1) Results of the previous round of expert consultation; (2) Summary of professional opinions; (3) Research team discussion feedback.

[0023] In the first round of Delphi expert consultation, 25 questionnaires were distributed, and 23 were actually returned, resulting in a response rate of 92.00%. The expert familiarity coefficient was Cs = 0.92; the expert judgment coefficient was Ca = 0.94; and the expert authority coefficient was Cr = 0.93. The expert consultation coordination coefficient was 0.504 (P < 0.001). In the second round of Delphi expert consultation, 33 questionnaires were distributed, and 32 were actually returned, resulting in a response rate of 96.97%. The expert familiarity coefficient was Cs = 0.88; the expert judgment coefficient was Ca = 0.92; and the expert consultation coordination coefficient was 0.561 (P < 0.001). Two rounds of the Delphi survey were conducted, one via email and the other via paper questionnaires. After each round, the research team analyzed and summarized the expert responses and revised the questionnaire for the next round accordingly. This process continued until the results stabilized, requiring at least two rounds, with each round spaced 1–3 weeks apart.

[0024] Item analysis and deletion Step 4: Descriptive statistical analysis was performed on the floor effect (a large number of scores are concentrated at 0 points and there is a lack of variation) of all biliary tract cancer symptom-specific symptom items, and items with a floor effect of less than 80% were screened.

[0025] Table 1. Item Score Distribution Step 5: First, use hierarchical cluster analysis to identify similar or redundant items among the symptom-specific entries for biliary tract cancer. Hierarchical clustering can visually demonstrate the staged clustering process, while factor analysis can only show the final clustering results.

[0026] Table 2 Scale Items for Different Developmental Stages Psychological characteristic measurement Step 6: Classical Test Theory (CTT): Examine the test-retest reliability of the scale to assess the stability of the tool. Complete the Bi-SA symptom assessment for two consecutive days while the patient's condition is stable, and then analyze the results.

[0027] Table 3. Reliability of Bi-SA: Cronbach's alpha coefficient and test-retest reliability after item removal. Step 7: Item Response Theory (IRT): Exploratory factor analysis (principal component method) was used to test for unidimensionality. The Kaiser-Meyer-Olkin (KMO) test and Bartlett's test of sphericity were used to verify that the data were suitable for exploratory factor analysis. A KMO value ≥ 0.7 and a Bartlett's test p < 0.001 indicate that the data are suitable for correlation analysis.

[0028] The GRM (Graded Response Model) assumes that the scale measurement is a unidimensional structure and is suitable for measuring homogeneous, graded scoring items. It includes two indicators: the discrimination parameter α (0 to +3 indicates good discrimination) and the difficulty parameter b (-4 to +4 indicates appropriate difficulty).

[0029] Table 4. Theoretical Reaction Parameters for the Bi-SA Project α = Discrimination parameter (i.e., the ability of a particular item to distinguish individuals with different levels of symptom experience). b1 to b10 = estimates of ten difficulty parameters (i.e., the level of trait symptom experience an individual needs to reach to give an affirmative answer).

[0030] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0031] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A PRO-based biliary tract cancer symptom scale development and validation system, characterized in that, It includes an item generation module, an item screening and optimization module, a psychometric verification module, and a scale output module, which are connected in sequence. The modules work together to complete the development and verification of the biliary tract cancer symptom scale. The entry generation module constructs an initial symptom entry library through a literature review; The item screening and optimization module uses the Delphi method combined with item score distribution analysis to screen core symptom items; The psychometric verification module uses classical testing theory and item response theory to verify the scale's characteristics. The scale output module generates the final biliary tract cancer symptom assessment scale.

2. The PRO-based biliary tract cancer symptom scale development and validation system according to claim 1, characterized in that, The process of constructing the initial symptom entry library by the entry generation module includes: setting a search deadline; selecting WebofScience, PubMed, VIP, Wanfang, and CNKI Chinese and English databases as search sources; performing a system search using "gallbladder cancer symptoms," "bile duct cancer symptoms," and "biliary tract tumor symptomology" as search keywords; having two independent reviewers screen the literature titles and abstracts, with senior researchers making the final decision in case of disagreement; conducting a full-text review of the approved literature; having the two reviewers independently extract symptom data, with senior researchers coordinating to reach a consensus in case of discrepancies; and integrating the data to form an initial symptom entry library containing 23 symptom entries.

3. The PRO-based biliary tract cancer symptom scale development and validation system according to claim 1, characterized in that, The item filtering and optimization module includes a Delphi method filtering unit and an item reduction unit; The Delphi method screening unit comprised a multidisciplinary team of 33 experts covering oncology, hepatobiliary surgery, clinical epidemiology, and psychology. Two rounds of Delphi questionnaires were designed. The first round included project descriptions, basic expert information, initial symptom items, open-ended suggestions, and expert self-assessment. The second round added the results of the previous round of consultations, a summary of professional opinions, and feedback from the research team. Questionnaires were distributed via a combination of email and paper questionnaires. In the first round, 25 questionnaires were distributed and 23 were returned; in the second round, 33 were distributed and 32 were returned. Expert authority and coordination coefficients were calculated, and 18 candidate symptom items with scores ≥4 were selected.

4. The PRO-based biliary tract cancer symptom scale development and validation system according to claim 3, characterized in that, The process of the item deletion unit is as follows: 175 patients with biliary tract cancer were included, and 18 candidate symptom items were scored using the 0-10 numerical rating scale (NRS); the score distribution of each item was analyzed, and the mean, standard deviation, missing rate and floor effect were calculated. Items with a floor effect of less than 80% were screened; similar or redundant items were identified using hierarchical cluster analysis, and 8 items including low back pain, jaundice, back pain, fever, diarrhea, shoulder pain, rash, and chills were deleted based on clinical significance, leaving 10 core symptom items.

5. The PRO-based biliary tract cancer symptom scale development and validation system according to claim 4, characterized in that, The 10 core symptom items are pain, abdominal distension, decreased appetite, nausea, aversion to oily foods, sleep disturbances, fatigue, itchy skin, drowsiness, and altered taste.

6. The PRO-based biliary tract cancer symptom scale development and validation system according to claim 1, characterized in that, The psychometric validation module includes a classical test theory validation unit and an item response theory validation unit. The classical test theory validation unit selected 86 patients with stable biliary tract cancer, who completed the core symptom item scoring for two consecutive days. The test-retest reliability and internal consistency reliability of the scale were calculated. The results showed that the overall Cronbach's α coefficient was 0.

79. After deleting any core item, the Cronbach's α coefficient was between 0.74 and 0.

79. The intragroup correlation coefficient of the test-retest reliability was between 0.77 and 0.

95.

7. The PRO-based biliary tract cancer symptom scale development and validation system according to claim 6, characterized in that, The project response theory validation unit conducted exploratory factor analysis on the scoring data of 175 patients, and validated the applicability of the data through the Kaiser-Meyer-Olkin (KMO) test and Bartlett's test of sphericity. The graded response model (GRM) was used to analyze the discrimination parameter α and difficulty parameter b of the core symptom items to validate the unidimensional structure, discrimination ability and difficulty appropriateness of the questionnaire.

8. The PRO-based biliary tract cancer symptom scale development and validation system according to claim 1, characterized in that, The Biliary Tract Cancer Symptom Assessment Scale (Bi-SA) generated by the scale output module includes two review time periods: a 24-hour review version and a 7-day review version. Both versions use the 0-10 Numerical Rating Scale (NRS), where 0 indicates no symptoms and 10 indicates the most severe symptoms.

9. The PRO-based biliary tract cancer symptom scale development and validation system according to claim 1, characterized in that, The scale output module generates paper and electronic versions of the scale, which can be used alone or in combination with other modular assessment tools for dynamic monitoring and assessment of symptoms in patients with biliary tract cancer.

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