Esophageal cancer radiotherapy patient symptom evaluation scale and development and verification method thereof

Abstract

The invention relates to the technical field of esophageal cancer treatment, in particular to an esophageal cancer radiotherapy patient symptom evaluation scale development and verification method, which comprises the following steps: constructing an initial entry pool; entries are screened to form a preliminary scale; performing preliminary simulation evaluation on the scale; cognizing and explaining scale entries and giving feedback; carrying out characteristic verification based on psychology; performing association degree verification based on the items and the core symptoms; and scale determination and application are realized based on a verification result. According to the esophageal cancer radiotherapy patient symptom assessment scale and the development and verification method thereof, the development process of the assessment scale is ensured through multi-dimensional entry pool construction, multi-round Delphi method screening and a system verification mechanism, and entries with low association degree with core symptoms are systematically eliminated, so that each entry is ensured to have clinical significance and reference value, and the development and verification of the esophageal cancer radiotherapy patient symptom assessment scale is facilitated. The entry design is optimized through the patient interviews and the cognitive interviews, so that the scale is ensured to fit the real feelings of the patient, and evaluation deviation caused by obscure terms or irrelevant entries is avoided.

Description

Technical Field

[0001] This invention relates to the field of esophageal cancer treatment technology, specifically to a symptom assessment scale for esophageal cancer radiotherapy patients and its development and validation methods. Background Technology

[0002] Currently, radiotherapy, chemotherapy, surgery, immunotherapy, and other methods are used clinically to treat esophageal cancer. However, the psychological stress on patients and the various adverse reactions and complications caused by treatment result in physical and mental trauma, which is one of the main reasons for treatment failure in esophageal cancer. Therefore, how to improve the survival rate and quality of life of esophageal cancer patients is one of the major issues facing the whole society. PRO-based symptom management is increasingly considered the best model of patient-centered medical care in clinical practice. PRO-based symptom management is a new approach to managing symptoms of radical radiotherapy, which can comprehensively, timely, and accurately predict the outcome events caused by negative symptoms, providing a prerequisite for timely clinical intervention.

[0003] A search revealed a method for auxiliary medical history collection and scale assessment for Parkinson's disease disclosed in Chinese Patent Publication No. CN117238427A. However, this method lacks an item screening and optimization mechanism and does not adequately emphasize patient-reported outcomes (PROs), resulting in a lack of scientific rigor in scale development and validation. Therefore, this paper proposes a symptom assessment scale for esophageal cancer radiotherapy patients and its development and validation method. Summary of the Invention

[0004] (a) Technical problems to be solved To address the shortcomings of existing technologies, this invention provides a symptom assessment scale for esophageal cancer radiotherapy patients and its development and validation method. This scale features the advantages of optimizing the scale's items and emphasizing the patient's subjective experience of symptom distress, thereby strengthening monitoring during the radiotherapy recovery period and achieving comprehensive patient management. It also solves the problem that existing scale assessment methods in the background art require further improvement in terms of the relevance of assessment items and the patient's subjective experience.

[0005] (II) Technical Solution To achieve the goal of understanding the current clinical symptoms based on the assessment scale, collecting information on patients' symptom concerns, thereby strengthening monitoring during the radiotherapy recovery period and realizing the whole-process management of patients, this invention provides the following technical solution: a symptom assessment scale for esophageal cancer radiotherapy patients, including a symptom type section, a detailed indicator section, an assessment level section, a self-test supplement section, and an assessment feedback section.

[0006] Preferably, the symptom type section includes gastrointestinal symptoms, systemic reaction symptoms, skin condition impact, and impact on lifestyle and psychological state. The detailed indicator section and the indicators corresponding to gastrointestinal symptoms include: 1) painful swallowing and difficulty eating; 2) heartburn and regurgitation; 3) nausea, vomiting or dry heaving; 4) dry mouth; 5) decreased appetite; 6) altered or lost taste. The detailed indicator section and the indicators corresponding to systemic reaction symptoms include: 1) fatigue and weakness; 2) body pain; 3) shortness of breath or rapid breathing; 4) hoarseness; 5) abdominal distension; 6) diarrhea; 7) constipation; 8) numbness; 9) cough; The detailed indicator section and the indicators corresponding to the skin condition include: 1) dry skin; 2) itchy skin; 3) red, swollen and ulcerated skin; The detailed indicators and the indicators corresponding to the impact on life and mental state include: 1) low mood or depression; 2) worry and anxiety; 3) limited daily activities; 4) decline in quality of life.

[0007] Preferably, the assessment level section includes constructing a scoring standard that increases from 1 to 10, specifically including: 1) When the assessment score is 0, the symptom indicator assessment result is determined to be asymptomatic; 2) When the assessment score is 1-3, the symptom indicator assessment result is determined to be mild symptoms; 3) When the assessment score is 4-7, the symptom indicator assessment result is considered to be obvious symptoms; 4) When the assessment score is 8-10, the symptom index is considered to indicate severe symptoms; The self-test supplement section is used to supplement symptoms not mentioned in the detailed indicator section, and the assessment feedback section is used to provide suggestions and individual needs based on daily symptom care.

[0008] A method for developing and validating a symptom assessment scale for esophageal cancer patients undergoing radiotherapy includes the following specific steps: S1. Construct an initial item pool; S2. Item selection to form a preliminary scale; S3. Preliminary simulation assessment of the scale; S4. Cognitive explanation and feedback of the scale items; S5. Characteristic verification based on psychometrics; S6. Correlation verification based on items and core symptoms; S7. Scale determination and application based on verification results.

[0009] Preferably, in step S1, based on literature retrieval, expert and patient interviews, and analysis of existing table indicators, the initial entry pool is constructed, specifically including: 1) Literature search: Based on relevant literature and treatises, search for data on the side effects, symptom management and quality of life of esophageal cancer, chest and upper gastrointestinal radiotherapy, and extract relevant symptom descriptions and assessment items; 2) Clinical expert interviews: Interviews with radiotherapy and oncology medical staff and rehabilitation therapists to understand the common symptoms and problems of esophageal cancer radiotherapy patients; 3) Patient interviews: Semi-structured interviews were conducted with esophageal cancer radiotherapy patients at different stages of radiotherapy, including pre-, mid-, and late-stage radiotherapy. Open-ended questions were used to obtain patients’ real symptom experiences, and different types of patients were covered. 4) Analysis of existing scales: Referencing existing mature general and specific scale techniques, adaptive adjustments are made based on their structure, items, and wording; In step S2, an expert review method is used to select target items for constructing the initial scale based on the symptoms of esophageal cancer radiotherapy. These items include: 1) By forming a multidisciplinary expert group, including personnel from radiotherapy, medical oncology, nursing, psychology, and scale methodology, 2-3 rounds of Delphi method consultation were conducted; 2) In the first round, experts will score the importance, relevance, and clarity of the initial pool of entries and provide specific suggestions for modifying, deleting, or adding entries; 3) In the second round, provide feedback on the results of the first round and summarize the opinions, then score again and discuss the points of disagreement; 4) Reach a final consensus in the third round and retain items with high importance scores and high consensus.

[0010] Preferably, in step S3, a portion of eligible esophageal cancer radiotherapy patients are selected, and the resulting initial scale is distributed to the patients for self-testing. In step S4, the patients read the initial items and undergo cognitive interviews to inquire about their understanding of the meaning of each item. The wording is modified based on the feedback, and the scale is revised based on the interview results to correct ambiguous or difficult-to-answer item questions. Repeat steps S3 and S4 multiple times to simulate patient assessment and scale revision. After assessing a large sample of patients, obtain the revised scale and perform psychometric verification in step S5, including: 1) Based on the internal consistency reliability, each section is considered good. Based on the test-retest reliability, the same patients are selected within a short period of time to re-fill out the scale, and the intragroup correlation coefficient (ICC) is calculated. When the ICC > 0.7, it indicates that the scale is stable. 2) The validity of construct validity, criterion-related validity and discriminant validity were verified respectively to test the goodness of fit between the model and actual data. Correlation analysis was performed on the total score and segment scores of this scale compared with existing related scales. The scale scores were used to predict future clinical outcomes and to anticipate significant differences between groups, demonstrating that the scale distinguishes patient groups with different symptom burdens. 3) Repeat the test on the same group of patients, calculate the effect size ES and the standardized response mean SRM, and assess the sensitivity of the response scale to detect changes in symptoms over time.

[0011] Preferably, in step S6, the correlation between the items and the core symptoms is verified to eliminate scale items with low correlation. This step includes: 1) Analyze the item distribution and response characteristics for each item in the pre-test and formal verification data; 2) Analyze the correlation between item and total score by calculating the correlation coefficient between the score of each item and the total score of its section, after removing the item; 3) Analyze item contribution based on exploratory factor analysis (EFA) and confirmatory factor analysis (CFA); 4) Analyze the discriminant validity based on the ability of the test items to differentiate between known patient groups; 5) Verify responsiveness sensitivity based on the effect size (ES) and standardized response mean (SRM) of the item scores.

[0012] (III) Beneficial Effects Compared with the prior art, the present invention provides a symptom assessment scale for esophageal cancer radiotherapy patients and a method for its development and validation, which has the following beneficial effects: 1. The symptom assessment scale for esophageal cancer radiotherapy patients and its development and validation methods ensured a complete and rigorous assessment scale development process through the construction of a multi-dimensional item pool, multiple rounds of Delphi method screening, and a systematic validation mechanism. By clearly setting exclusion criteria, items with low correlation to core symptoms were systematically excluded, thereby ensuring that each item has clinical significance and reference value.

[0013] 2. The symptom assessment scale for esophageal cancer radiotherapy patients and its development and validation methods were optimized through patient interviews and cognitive interviews to ensure that the scale reflects the patients' true feelings and avoids assessment bias caused by obscure terminology or irrelevant items. Thus, it is patient-centered and aims to emphasize subjective experience. Attached Figure Description

[0014] Figure 1 This is a schematic diagram of the symptom assessment scale for esophageal cancer radiotherapy patients of the present invention; Figure 2 This is a schematic diagram of the process for screening and removing scale items that are not highly correlated with the core symptoms according to the present invention.

[0015] In the diagram: 1. Symptom Types Section; 2. Detailed Indicators Section; 3. Assessment Level Section; 4. Self-Assessment Supplement Section; 5. Assessment Feedback Section. Detailed Implementation

[0016] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments and 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.

[0017] Example 1 In this embodiment, the psychometric properties of the assessment scale obtained after evaluating a large sample of patients are validated, including: 1) Reliability includes internal consistency reliability and test-retest reliability. Based on internal consistency reliability, each section is considered good. Based on test-retest reliability, the same patients are selected within a short period of time to re-fill out the scale, and the intragroup correlation coefficient (ICC) is calculated. When ICC > 0.7, it indicates that the scale is stable.

[0018] 2) Validation verification includes: a. Ensuring validity during the development phase through literature review, expert and patient interviews, and Delphi method content; b. Construct validity: Exploratory factor EFA analysis was conducted by combining the intrinsic relationships between different items. Based on the actual data, the pre-set factor structure was supported, and items with high cross-loads and low factor loads were deleted. Confirmatory factor analysis (CFA) was conducted based on the pre-defined structural model. Statistical indicators included CFI>0.90, TLI>0.90, RMSEA<0.08, and SRMR<0.08 to test the goodness of fit between the model and the actual data and to validate the scale structure. c. Criterion-related validity: The total score and segment scores of this scale were compared with existing related scales to conduct a correlation analysis, including data indicators such as the EORTCQLQ-C30 subscale, the EORTCQLQ-OES18 subscale, the VAS pain score, and the CTCAE severity grading assessed by physicians. The validation threshold was set to achieve a moderate to high correlation. It also examines whether the scale scores can predict important future clinical outcomes, including data on treatment interruption, emergency room visits, hospitalization, changes in quality of life, and survival. d. Discriminant validity: By comparing the specific circumstances of patients with different clinical characteristics, including before, during and after radiotherapy; different radiotherapy doses and fractionation methods; whether concurrent chemotherapy was used; different tumor stages and different physical performance status PS scores, the scale scores were calculated under different circumstances. Based on the analysis of variance, significant differences between different groups were expected, thus demonstrating that the scale can distinguish patient groups with different symptom burdens.

[0019] 3) Response rate: By assessing the sensitivity of the scale to detect changes in symptoms over time, the same group of patients were repeatedly measured at key points during radiotherapy. The effect size ES and the standardized mean response SRM were calculated, and it was observed whether the changes in the scale scores were consistent with clinical expectations.

[0020] Example 2 In this embodiment, during the scale development and validation process, items with low relevance to the patient's core symptoms are systematically removed, and the assessment scale is optimized. Specifically, this includes: 1) Analyze the item distribution and response characteristics, including: a. A missing rate >10% indicates that the problem is difficult to understand or is not applicable; b. When the ceiling or floor effect is >70%, it indicates that the patient's choice of the lowest score (floor) or highest score (ceiling) suggests low item discrimination. c. In an extremely skewed distribution, when |skewness|>2, it indicates that the items cannot effectively distinguish patients; At this point, the criteria for item removal are set as follows: if the item missing rate is >15% or >75% of patients select asymptomatic based on the floor effect, removal should be considered. 2) Analyze the correlation between items and total scores. Calculate the correlation coefficient between the score of each item and the total score of its respective section (after removing the item). The removal criterion is: if the corrected item-total score correlation coefficient is <0.40, it indicates that the item has low consistency with the concept of its respective section and should be considered for removal. 3) Analyze the contribution of each item in the factor analysis, including: a. Exploratory Factor Analysis (EFA): Items with factor loadings > 0.50 and no cross-loadings (other factor loadings < 0.40) are retained; b. When the ceiling or floor effect is >70%, it indicates that the patient's choice of the lowest score (floor) or highest score (ceiling) suggests low item discrimination. The exclusion criteria are set as follows: if the item has a loading of only 0.35 on the gastrointestinal symptom factors, or has cross loadings on multiple factors, it indicates that its measurement target is unclear and should be considered for exclusion. 4) Discriminant validity analysis, including: a. Compare the differences in item scores among patients at different stages of radiotherapy; b. Compare the score differences between the symptom severity groups; At this point, the criteria for item removal are set as follows: if the score of the item does not show significant differences in each stage of radiotherapy (i.e., p>0.05), or is not correlated with the severity of diarrhea assessed by the doctor (i.e., r<0.30), it indicates that its clinical sensitivity is insufficient and should be considered for removal. 5) Reactivity sensitivity verification, including: The item exclusion criteria were set using the effect size (ES) or standardized response mean (SRM) of the item score: if the ES of the item during the period of worsening radiotherapy symptoms was <0.20, it indicated that the item could not capture the dynamic changes in symptoms and should be considered for exclusion.

[0021] Even if the statistical indicators for this item are not fully met, it should be retained if the following conditions are met: 1) Clinical expert consensus: A multidisciplinary expert group has recognized that this symptom has important monitoring value; 2) Patient report priority: >20% of patients actively mention this symptom item in open-ended questions; 3) Predictive value: This item can significantly predict serious complications; Based on the validation results, the final scale items, section structure, and scoring method were determined. At the same time, a detailed user manual was developed to guide how to implement, score, and interpret the results. The scale was promoted and applied in clinical practice and research, and feedback and item updates were continuously collected.

[0022] Example 3 In this embodiment, a symptom assessment scale for esophageal cancer radiotherapy patients is generated according to the assessment scale development method, as shown in the table below: Based on the validation method for the assessment scale, the scale was optimized by removing items that were not highly correlated with the patient's core symptoms, as shown in the table below: The beneficial effects of this invention are as follows: The symptom assessment scale for esophageal cancer radiotherapy patients and its development and validation method ensure a complete and rigorous assessment scale development process through the construction of a multi-dimensional item pool, multiple rounds of Delphi method screening, and a systematic validation mechanism. By clearly setting elimination criteria, items with low correlation to core symptoms are systematically eliminated, thereby ensuring that each item has clinical significance and reference value. Through patient interviews and cognitive interviews, the item design is optimized to ensure that the scale reflects the patient's true feelings and avoids assessment bias caused by obscure terminology or irrelevant items. Thus, it is patient-centered and achieves the goal of emphasizing subjective experience.

[0023] 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 symptom assessment scale for esophageal cancer patients undergoing radiotherapy, characterized in that, It includes a symptom type section (1), a detailed indicator section (2), an assessment level section (3), a self-test supplement section (4), and an assessment feedback section (5).

2. The symptom assessment scale for esophageal cancer radiotherapy patients according to claim 1, characterized in that, The symptom type section (1) includes gastrointestinal symptoms, systemic reaction symptoms, skin condition impact, and life and psychological state impact. The detailed indicator section (2) includes indicators corresponding to gastrointestinal symptoms, such as: 1) pain in swallowing and difficulty in eating; 2) heartburn and regurgitation; 3) nausea, vomiting or dry heaving; 4) dry mouth; 5) loss of appetite; 6) changes or loss of taste. The detailed indicator section (2) includes the following indicators corresponding to systemic reaction symptoms: 1) fatigue and weakness; 2) body pain; 3) shortness of breath or rapid breathing; 4) hoarseness; 5) abdominal distension; 6) diarrhea; 7) constipation; 8) numbness; 9) cough; The detailed indicator section (2) includes the following indicators corresponding to the impact on skin condition: 1) dry skin; 2) itchy skin; 3) red, swollen and ulcerated skin. The detailed indicator section (2) includes indicators corresponding to the impact on life and psychological state, such as: 1) low mood or depression; 2) worry and anxiety; 3) limited daily activities; and 4) decline in quality of life.

3. The symptom assessment scale for esophageal cancer radiotherapy patients according to claim 1, characterized in that, The assessment level section (3) includes the construction of an incremental scoring standard from 1 to 10, specifically including: 1) When the assessment score is 0, the symptom indicator assessment result is determined to be asymptomatic; 2) When the assessment score is 1-3, the symptom indicator assessment result is determined to be mild symptoms; 3) When the assessment score is 4-7, the symptom indicator assessment result is considered to be obvious symptoms; 4) When the assessment score is 8-10, the symptom index is considered to indicate severe symptoms; The self-test supplementary section (4) is used to supplement symptoms not mentioned in the detailed indicator section (2), and the assessment feedback section (5) is used to provide suggestions and personal needs based on daily symptom care.

4. A method for developing and validating a symptom assessment scale for esophageal cancer patients undergoing radiotherapy, characterized in that, The specific steps include the following: S1. Construct an initial item pool; S2. Item selection to form a preliminary scale; S3. Initial simulation assessment of the scale; S4. Explanation and feedback on the understanding of the scale items; S5. Validate characteristics based on psychometrics; S6. Validate the correlation between items and core symptoms; S7. Scale determination and application based on verification results.

5. The method for developing and validating a symptom assessment scale for esophageal cancer radiotherapy patients according to claim 4, characterized in that, In step S1, based on literature retrieval, expert and patient interviews, and analysis of existing table indicators, the initial entry pool is constructed, specifically including: 1) Literature search: Based on relevant literature and treatises, search for data on the side effects, symptom management and quality of life of esophageal cancer, chest and upper gastrointestinal radiotherapy, and extract relevant symptom descriptions and assessment items; 2) Clinical expert interviews: Interviews with radiotherapy and oncology medical staff and rehabilitation therapists to understand the common symptoms and problems of esophageal cancer radiotherapy patients; 3) Patient interviews: Semi-structured interviews were conducted with esophageal cancer radiotherapy patients at different stages of radiotherapy, including pre-, mid-, and late-stage radiotherapy. Open-ended questions were used to obtain patients’ real symptom experiences, and different types of patients were covered. 4) Analysis of existing scales: Referencing existing mature general and specific scale techniques, adaptive adjustments are made based on their structure, items, and wording; In step S2, an expert review method is used to select target items for constructing the initial scale based on the symptoms of esophageal cancer radiotherapy. These items include: 1) By forming a multidisciplinary expert group, including personnel from radiotherapy, medical oncology, nursing, psychology, and scale methodology, 2-3 rounds of Delphi method consultation were conducted; 2) In the first round, experts will score the importance, relevance, and clarity of the initial pool of entries and provide specific suggestions for modifying, deleting, or adding entries; 3) In the second round, provide feedback on the results of the first round and summarize the opinions, then score again and discuss the points of disagreement; 4) Reach a final consensus in the third round and retain items with high importance scores and high consensus.

6. The method for developing and validating a symptom assessment scale for esophageal cancer radiotherapy patients according to claim 4, characterized in that, In step S3, a portion of eligible esophageal cancer radiotherapy patients are selected, and the resulting initial scale is distributed to the patients for self-testing. In step S4, the patients read the initial items and undergo cognitive interviews to inquire about their understanding of the meaning of each item. The wording is modified based on the feedback, and the scale is revised based on the interview results to correct ambiguous or difficult-to-answer questions. Repeat steps S3 and S4 multiple times to simulate patient assessment and scale revision. After assessing a large sample of patients, obtain the revised scale and perform psychometric verification in step S5, including: 1) Based on the internal consistency reliability, each section is considered good. Based on the test-retest reliability, the same patients are selected within a short period of time to re-fill out the scale, and the intragroup correlation coefficient (ICC) is calculated. When the ICC > 0.7, it indicates that the scale is stable. 2) The validity of construct validity, criterion-related validity and discriminant validity were verified respectively to test the goodness of fit between the model and actual data. Correlation analysis was performed on the total score and segment scores of this scale compared with existing related scales. The scale scores were used to predict future clinical outcomes and to anticipate significant differences between groups, demonstrating that the scale distinguishes patient groups with different symptom burdens. 3) Repeat the test on the same group of patients, calculate the effect size ES and the standardized response mean SRM, and assess the sensitivity of the response scale to detect changes in symptoms over time.

7. The method for developing and validating a symptom assessment scale for esophageal cancer radiotherapy patients according to claim 4, characterized in that, In step S6, the correlation between the items and the core symptoms is verified to eliminate scale items with low correlation. This step includes: 1) Analyze the item distribution and response characteristics for each item in the pre-test and formal verification data; 2) Analyze the correlation between item and total score by calculating the correlation coefficient between the score of each item and the total score of its section, after removing the item; 3) Analyze item contribution based on exploratory factor analysis (EFA) and confirmatory factor analysis (CFA); 4) Analyze the discriminant validity based on the ability of the test items to differentiate between known patient groups; 5) Verify responsiveness sensitivity based on the effect size (ES) and standardized response mean (SRM) of the item scores.

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