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The minimal clinically important difference (MCID) is an important concept with big appeal in a field struggling to interpret quality of life (QOL) and other patient-reported outcomes (PRO), is also a bridge between statistics and clinical medicine. This study uses the ROC curve to formulate the MCID value of the Quality of Life Instruments for Chronic Diseases of Systemic lupus erythematosus (QLICD-SLE V2.0) scale. Using the representative item "In general, would you say your health is" of the MOS item short form health survey(SF-36) as an anchor, the questionnaire of QLICD-SLE V2.0 and the anchor item were used to investigate the patients on the first day of hospitalization, and the day before the patient was discharged. 279 patients with lupus erythematosus were participated in this longitudinal follow-up study. The ROC curve was constructed by using the classification based on the anchor item as the gold standard and the difference score of the scale as the test variable. The cut-off point corresponding to the maximum value of the Youden index in the ROC curve is taken as the minimum clinical importance difference (MCID) value of the QLICD-SLE (V2.0) scale. The Results showed that the MCID of physical domain, psychological domain, social domain, general module, specific module and QLICD-SLE (V2.0) total scale are 8.3, 2.3, 2.5, 2.7, 9.2 and 3.2, respectively. Area under the ROC curve of QLICD-SLE (V2.0) is 0.898, P (Area = 0.5) < 0.001, the sensitivity is 100%, the specificity is 66.9%. It concluded that if the total scores after treatments changes at least 3.2 points positively, the treatment intervention can be considered as clinically significant. It is more convincing to use the corresponding cut-off point as the MCID for ROC curve method can visualize the sensitivity and specificity., (© 2024. The Author(s).)

Background: Quality of life research can guide clinical workers to adopt more targeted treatment and intervention measures, so as to achieve the purpose of improving patients' quality of life. The objective of this study was to evaluate health-related quality of life in Chinese patients with cervical cancer and to explore its influencing factors., Methods: A total of 186 patients with cervical cancer were investigated by using the QLICP-CE (V2.0) scale (Quality of Life Instruments for Cancer Patients-Cervical Cancer) developed by our group in China. The data were analyzed by t-test, one-way ANOVA, univariate analysis, and multivariate linear regression., Results: The total score of quality of life scale for cervical cancer patients was (62.58 ± 12.69), Univariate analysis of objective clinical indexes showed that creatinine concentration was a negative influence factor in the psychological domain, potassium ion concentration was a negative influence factor in the common symptoms and side effect domain, erythrocyte content was a positive influence factor physical domain and common general domain. Multiple linear regression results suggested that clinical staging was the influencing factor of common symptom and side effect domain, common general module and total score of scale. Marital status has different degrees of influence on the psychological, social, and common general domains. The level of education also influenced scores in the social domain., Conclusion: The total score of quality of life in patients with cervical cancer who received active treatment was acceptable. Marital status, clinical staging, and educational level are the factors that affect the quality of life of patients with cervical cancer. At the same time, potassium ion concentration, red blood cell count and creatinine concentration also have important effects on quality of life in patients with cervical cancer. Therefore, it is very important to give personalized treatment and nursing to patients based on various factors., (© 2024. The Author(s).)

Background: Quality of life of osteoporosis patients had caused widespread concern, due to high incidence and difficulty to cure. Scale specifics for osteoporosis and suitable for Chinese cultural background lacked. This study aimed to develop an osteoporosis scale in Quality of Life Instruments for Chronic Diseases system, namely QLICD-OS (V2.0)., Methods: Procedural decision-making approach of nominal group, focus group and modular approach were adopted. Our scale was developed based on experience of establishing scales at home and abroad. In this study, Quality of life measurements were performed on 127 osteoporosis patients before and after treatment to evaluate the psychometric properties. Validity was evaluated by qualitative analysis, item-domain correlation analysis, multi-scaling analysis and factor analysis; the SF-36 scale was used as criterion to carry out correlation analysis for criterion-related validity. The reliability was evaluated by the internal consistency coefficients Cronbach's α, test-retest reliability Pearson correlation r. Paired t-tests were performed on data of ​​the scale before and after treatment, with Standardized Response Mean (SRM) being calculated to evaluate the responsiveness., Results: The QLICD-OS, composed of a general module (28 items) and an osteoporosis-specific module (14 items), had good content validity. Correlation analysis and factor analysis confirmed the construct, with the item having a strong correlation (most > 0.40) with its own domains/principle components, and a weak correlation (< 0.40) with other domains/principle components. Correlation coefficient between the similar domains of QLICD-OS and SF-36 showed reasonable criterion-related validity, with all coefficients r being greater than 0.40 exception of physical function of SF-36 and physical domain of QLICD-OS (0.24). Internal consistency reliability of QLICD-OS in all domains was greater than 0.7 except the specific module. The test-retest reliability coefficients (Pearson r) in all domains and overall score are higher than 0.80. Score changes after treatment were statistically significant, with SRM ranging from 0.35 to 0.79, indicating that QLICD-OS could be rated as medium responsiveness., Conclusion: As the first osteoporosis-specific quality of life scale developed by the modular approach in China, the QLICD-OS showed good reliability, validity and medium responsiveness, and could be used to measure quality of life in osteoporosis patients., (© 2024. The Author(s).)

Rheumatoid Arthritis is a more serious threatening to people and suitable for QOL measurement. A few specific QOL instruments are available without considering Chinese culture. The present study was aimed to develop and validate the Rheumatoid Arthritis Scale among the System of Quality of Life Instruments for Chronic Diseases (QLICD-RA V2.0). The data collected from 379 patients with RA was used to evaluate the psychometric properties of the scale. The reliability was evaluated by the internal consistency Cronbach's α, test-retest reliability Pearson correlation r and intra-class correlation (ICC). We evaluated the construct validity and criteria-related validity by correlation analysis and structural equation modeling. We compared the differences in scores of QLICD-RA before and after treatment and used the Standard Response Mean (SRM) to assess the responsiveness. The results showed that the internal consistency coefficient Cronbach's α values were greater than 0.70. The correlations r and ICCs were greater than 0.80. The correlation analysis and structural equation modeling confirmed good construct validity and criterion-related validity. The SRM ranges from 0.07 to 0.27 for significant domains/facets. It concluded that QLICD-RA (2.0) is a reliable and valid instrument to measure QOL among patients with RA., (© 2024. The Author(s).)

Objective: The present study is aimed to develop and validate a quality of life scale for systemic lupus erythematosus (SLE) patients with Chinese cultural background, QLICD-SLE (V2.0)., Methods: The QLICD-SLE (V2.0) was developed using a systematic approach that involved focus groups, nominal discussions, and pilot testing. A total of 428 SLE patients participated in the scale's assessment. Validity was examined through qualitative analysis, item domain correlation, multidimensional scaling, and factor analysis. Reliability was assessed using Pearson's correlation and Cronbach's alpha coefficients. To evaluate responsiveness, paired T-tests were conducted to compare pre- and post-treatment measurements with the standardised response mean (SRM) being calculated., Results: Correlation and factor analyses demonstrated strong construct validity. When using SF-36 as criteria, the correlation between various domains of QLICD-SLE and SF-36 ranged from 0.55 to 0.70. Test-retest correlation coefficients exceeded 0.71, and Cronbach's alpha coefficients for both measurements in each domain were greater than or equal to 0.75. T-test results showed that both the overall score and most facet scores within each domain showed statistically significant changes after treatment (P < 0.05), indicating reasonable responsiveness., Conclusion: The QLICD-SLE (V2.0) appears to be a valid and reliable instrument for assessing the quality of life in patients with SLE., (© 2023. The Author(s).)

Introduction: The study explored the relationship between subjective well-being and the quality of life among older adults. It highlights the importance of understanding how these factors are interconnected in the context of an aging population., Methods: Descriptive statistics were used to analyze the scores of general demographic characteristics, subjective wellbeing and quality of life. Simple correlation analysis and canonical correlation analysis were employed to analyze the relationship between subjective wellbeing and quality of life among older adults., Results: Data from 892 older adults were collected. Canonical correlation analysis revealed four pairs of canonical variables, with the first four pairs of canonical correlation coefficients all being statistically significant (0.695, 0.179, 0.147, 0.121) ( p < 0.05), and the first pair of canonical variables explaining 93.03% of the information content. From the canonical loading coefficients, Vitality and mental health contributed the most to the quality of life (U1) canonical variable. The canonical variable V1, which corresponded to subjective wellbeing, was reflected by a combination of positive affect, negative affect, positive experience and negative experience. X1 (physical functioning), X2 (role-physical), X3 (bodily pain), X4 (general health), X5 (vitality), X6 (social functioning), X7 (role-emotional) and X8 (mental health) were positively correlated with Y1 (positive affect) and Y3 (positive experience), negatively correlated with Y2 (negative affect) and Y4 (negative experience). Cross-loadings revealed that physical functioning, bodily pain, general health, vitality, social functioning and mental health were the main factors reflecting the subjective wellbeing of older adults., Discussion: As quality of life among older adults was highly correlated with subjective wellbeing, appropriate measures should be taken to account for individual characteristics of older adults, and various factors should be integrated to improve their subjective wellbeing., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Liu, Gan, Tan, Sun, Liu and Wan.)

The purpose of the present study is to develop and validate the hypertension scale of the Quality of Life Instruments (QoL) for Chronic Diseases system, QLICD-HY (V2.0). The QLICD-HY (V2.0) was developed via a programmed decision method with several focus groups, nominal discussions and pilot testing. The data was collected from 370 hypertensive inpatients and measured their QoL three times before and after treatment. Using correlation, factor analyses, as well as t-tests, the psychometric properties of the scale were assessed with regard to validity, reliability and responsiveness. Correlation and factor analysis supported good construct validity and criterion-related validity when using Short Form 36 as a criterion. Test-retest reliability coefficients for the overall scale score and all domains, with the exception of the psychological and social domain (0.77, 0.78), were greater than 0.80, with a range of 0.77-0.92. The internal consistency for all domains was higher than 0.70. With the exception of the psychological domain and social domain, the overall score and scores for the majority of aspects within each domain underwent statistically significant changes (t-tests) after the treatment. The QLICD-HY (V2.0) has good validity, reliability and responsiveness and can be used as a QoL measure for hypertensive patients., (© 2023. Springer Nature Limited.)

Background: To establish the lowest score reflecting meaningful changes from the perspective of patients is very important for explaining the results of patient reports. The measurement scale of quality of life in patients with chronic gastritis has been used in clinical practice, but the minimal clinically important difference (MCID) has not been worked out. In this paper, we use a distribution-based method to calculate the MCID of the scale QLICD-CG (Quality of Life Instruments for Chronic Diseases- Chronic Gastritis) (V2.0)., Methods: The QLICD-CG(V2.0) scale was used to evaluate the quality of life in patients with chronic gastritis. Since the methods for developing MCID were diverse and there was no uniform standard, we took MCID developed by anchor-based method as the gold standard, and compared the MCID of QLICD-CG(V2.0) scale developed by various distribution-based methods for selection. Standard deviation method (SD), effect size method (ES), standardized response mean method (SRM), standard error of measurement method (SEM) and reliable change index method (RCI) are given in the distribution-based methods., Results: A total of 163 patients, with an average age of (52.37 ± 12.96) years old, were calculated according to the various methods and formulas given by the distribution-based method, and the results were compared with the gold standard. It was suggested that the results of the SEM method at the moderate effect (1.96) should be taken as the preferred MCID of the distribution-based method. And thus the MCID of the physical domain, psychological domain, social domain, general module, specific module and total score of the QLICD-CG(V2.0) scale were 9.29, 13.59, 9.27, 8.29, 13.49 and 7.86, respectively., Conclusions: With anchor-based method as the gold standard, each method in distribution-based method has its own advantages and disadvantages. In this paper, 1.96SEM was found to have a good effect on the minimum clinically significant difference of the QLICD-CG(V2.0) scale, and it is recommended as the preferred method to establish MCID., (© 2023. The Author(s).)

Background: A short instrument would enhance the viability of a study. Therefore, we aimed to shorten the specific module (SPD-10) of the Quality of Life Instrument for Chronic Diseases - Chronic Renal Failure (QLICD-CRF) for assessing the quality of life of patients with chronic renal failure., Methods: The 10-item SPD-10 was self-administered to 164 patients with chronic renal failure. A shortened form was first obtained by a tandem use of the classical test theory (CTT), the generalizability theory (GT), and the item response theory (IRT). In addition, we also shortened the SPD-10 by the Optimal Test Assembly (OTA)., Results: Both the tandem use of GT, CTT and IRT, and the OTA derived the same 7-item shortened version (SPD-7). It included items CRF1, CRF2, CRF3, CRF4, CRF6, CRF8, and CRF9 of the SPD-10. The SPD-7 had a Cronbach alpha of 0.78. The correlation coefficients of its total and factor scores with those of the SPD-10 were 0.96 and 0.98, respectively. Confirmatory factor analysis confirmed the unidimensional structure of the SPD-7, with the comparative fit index=0.96, the Tucker-Lewis index=0.94, and the root mean square error of approximation=0.09., Conclusion: The short-form SPD-7 is reliable and valid for assessing the impact of clinical symptoms and side effects on the quality of life of patients with chronic renal failure. It is an efficient option without compromising the measurement performance of the SPD-10., (© 2022. The Author(s).)

Background: The Quality of Life Instrument for Chronic Diseases (QLICD)-COPD (V2.0) was designed to assess the health condition of patients with chronic obstructive pulmonary disease (COPD). The objective of this study was to evaluate the quality of life (QOL) of patients, the influential clinical factors and the relationships between QOL and clinical objective indicators., Methods: Two hundred and sixty-one inpatients with COPD in the acute exacerbation stage were evaluated using the QLICD-COPD (V2.0) and data on clinical objective indicators were collected. The relationships between QOL and the clinical objective indicators were determined using canonical correlation analysis., Results: The standardised scores for the patients in four domains, namely, physical function, psychological function, social function and a disease-specific module, were 49.00±12.91, 59.89±13.51, 68.59±11.94 and 51.84±13.58, respectively. The total score for the QOL of patients was 57.17±10.26. Two pairs of canonical variables were statistically significant (r 1 =0.35, p<0.0001; r 2 =0.26, p<0.05). These variables accounted for 45.8% and 33.8% of the variance, respectively. The levels of total protein, albumin, serum sodium and alkaline phosphatase and the percentages of neutrophils and lymphocytes were correlated with the QOL, with correlation coefficients ranging from -0.435 to 0.675., Conclusion: Clinicians should pay close attention to the levels of total protein, albumin, serum sodium and alkaline phosphatase and the percentages of neutrophils and lymphocytes to improve the QOL of patients., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Purpose: Psoriasis (PS) is difficult to cure with a high incidence. Therefore, the quality of life (QOL) of people with Psoriasis has caused widespread concern. Universal scales respond poorly to subtle changes caused by specific diseases, which makes it challenging to fully understand the impact of QOL in patients with psoriasis. In view of the deficiencies of the universal scale and the lack of a specific scale suitable for Chinese cultural background, this study aims to develop the psoriasis scale among the system of QOL instruments for chronic diseases QLICD-PS (V2.0)., Methods: The scale QLICD-PS (V2.0) was developed based on the procedural decision-making approach and the experience of establishing scales at home and abroad. 122 patients with psoriasis were participated in measuring QOL 3 times before and after treatments. The reliability was assessed by test-retest reliability (Pearson's correlation coefficients) and also internal consistency (Cronbach's alpha coefficients). Qualitative analysis was adopted to evaluate content validity; item-domain correlation analysis, multi-dimensional scaling analysis, and factor analysis were adopted to evaluate the construct validity; the SF-36 scale was used as the criterion to evaluate the criterion-related validity due to lack of gold standard. Paired t tests were performed to evaluate the responsiveness on each domain/facet as well as the total of the scale, with Standardized Response Mean (SRM) being calculated., Results: The QLICD-PS was composed of the general module including 3 domains (28 items) and the psoriasis specific module (13 items). The Cronbach's α of the specific module, the general module and the total scale of the QLICD-PS was 0.78, 0.87 and 0.74 respectively, the split-half reliability of the specific module, the general module and the total scale was 0.81, 0.91 and 0.81, respectively, both indicating high reliability. Correlation and factor analysis confirmed good construct validity and criterion-related validity. After treatments, the score changes in the total scale were statistically significant with SRM being 0.5, showing moderate responsiveness., Conclusion: As the first psoriasis-specific QOL scale developed by the modular approach in Chinese, the QLICD-PS showed good reliability, validity and responsiveness, and could be used to measure the QOL of Patients with psoriasis specifically and sufficiently., (© 2022. The Author(s).)

Background and Aim: Quality of life (QOL) for patients with chronic gastritis (CG) is of interest worldwide and disease-specific instruments are needed for clinical research and practice. This paper focused on the development and validation of the CG scale under the system of Quality of Life Instruments for Chronic Diseases (QLICD-CG) by the modular approach and both classical test theory and generalizability theory., Methods: The QLICD-CG was developed based on programmed decision procedures including multiple nominal and focus group discussions, in-depth interviews and quantitative statistical procedures. Based on the data measuring QOL 3 times before and after treatments from 142 inpatients with CG, the psychometric properties of the scale were evaluated with respect to validity, reliability and responsiveness employing correlation analysis, multi-trait scaling analysis, factor analyses, t tests and also G studies and D studies of generalizability theory analysis., Results: Correlation, multi-trait scaling and factor analyses confirmed good construct validity and criterion-related validity when using SF-36 as a criterion. The internal consistency α for all domains were higher than 0.70 except for the social domain (0.62). Test-retest reliability coefficients (Pearson r and intraclass correlations) for the overall score and all domains were higher than 0.80 except for the social domain (0.77), while they were ranging between 0.72 to 0.94 at facets level; The overall score and scores for all domains/facets had statistically significant changes (P<0.01) after treatments except for facets of social effects and sexual function with standardized response mean ranging from 0.04 to 1.03, but from 0.34 to 1.03 for the domain level scores. G-coefficients and index of dependability (Ф coefficients) confirmed the reliability of the scale further with more exact variance components, and decision information on number of items changing., Conclusions: The QLICD-CG could be used as a useful instrument in assessing QoL for patients with CG, with good psychometric properties including validity, reliability and responsiveness and also several advantages., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Quality of life (QOL) in patients with Chronic obstructive pulmonary disease (COPD) is a major global concern in respiratory care with the specific instruments used rarely being developed using a modular approach. This paper is aimed to develop the COPD scale of the system of QOL Instruments for Chronic Diseases (QLICD-COPD) by the modular approach based on Classical Test Theory and Generalizability Theory (GT). 114 inpatients with COPD were used to provide the data measuring QOL three times before and after treatments. The psychometric properties of the scale were evaluated with respect to validity, reliability and responsiveness employing correlation analysis, factor analyses, multi-trait scaling analysis, and also GT analysis. The Results showed that Multi-trait scaling analysis, correlation and factor analyses confirmed good construct validity and criterion-related validity with almost all correlation coefficients or factor loadings being above 0.40. The internal consistency α and test-retest reliability coefficients (Pearson r and Intra-class correlations ICC) for all domains except for the social domain were larger than 0.70, ranging between 0.70-0.86 with r = 0.85 for the overall. The overall score and scores for physical and the specific domains had statistically significant changes after treatments with moderate effect size SRM (standardized response mean) ranging from 0.32 to 0.44. All G-coefficients and index of dependability were all greater than 0.80 exception of social domain (0.546 and 0.500 respectively), confirming the reliability of the scale further. It concluded that the QLICD-COPD has good validity, reliability, and moderate responsiveness, and can be used as the QOL instrument for patients with COPD.

Background: The development of the minimum clinical important difference (MCID) can make it easier for researchers or doctors to judge the significance of research results and the effect of intervention measures, and improve the evaluation system of efficacy. This paper is aimed to calculate the MCID based on anchor and to develop MCID for esophageal cancer scale (QLICP-ES)., Methods: The item Q29 (How do you evaluate your overall health in the past week with 7 grades answers from 1 very poor to 7 excellent)of EORTC QLQ-C30 was used as the subjective anchor to calculate the score difference between each domain at discharge and admission. MCID was established according to two standards, "one grade difference"(A) and "at least one grade difference"(B), and developed by three methods: anchor-based method, ROC curve method and multiple linear regression models. In terms of anchor-based method, the mean of the absolute value of the difference before and after treatments is MCID. The point with the best sensitivity and specificity-Yorden index at the ROC curve is MCID for ROC curve method. In contrast, the predicted mean value based on a multiple linear regression model and the parameters of each factor is MCID., Results: Most of the correlation coefficients of Q29 and various domains of the QLICP-ES were higher than 0.30. The rank of MCID values determined by different methods and standards were as follows: standard B > standard A, anchor-based method > ROC curve method > multiple linear regression models. The recommended MCID values of physical domain, psychological domain, social domain, common symptom and side-effects domain, the specific domain and the overall of the QLICP-ES were 7.8, 9.7, 4.7, 3.6, 4.3, 2.3 and 2.9, respectively., Conclusion: Different methods have their own advantages and disadvantages, and also different definitions and standards can be adopted according to research purposes and methods. A lot of different MCID values were presented in this paper so that it can be easy and convenient to select by users.

Health-related quality of life (HRQOL) assessment is important to facilitate decisions in the current treatment landscape of chronic myeloid leukemia (CML). Therefore, the availability of a validated HRQOL questionnaire, specifically developed for CML patients treated with tyrosine kinase inhibitors (TKIs), may enhance quality of research in this area. We performed an international study including 782 CML patients to assess the validity of the EORTC QLQ-CML 24 questionnaire, and to generate HRQOL reference values to facilitate interpretation of results in future studies. Internal consistency, assessed with Cronbach's alpha coefficients, ranged from 0.66 to 0.83. In the confirmatory factor analysis, all standardized factor loadings exceeded the threshold of 0.40 (range 0.49-0.97), confirming the hypothesized scale structure. Reference values stratified by age and sex were also generated. Our findings support the use of the EORTC QLQ-CML 24, in conjunction with the EORTC QLQ-C30, as a valuable measure to assess HRQOL in CML patients.

Background: Quality of life (QOL) for patients with Peptic ulcer disease (PUD) is of interest worldwide and disease-specific instruments are needed for clinical research and practice. This paper focus on the development and validation of the PUD scale under the system of quality of life instruments for chronic diseases (QLICD-PU) by the modular approach and both classical test theory and Generalizability Theory., Methods: The QLICD-PU is developed based on programmatic decision-making procedures, including multiple nominal and focus group discussions, in-depth interviews, and quantitative statistical procedures. Based on the data of 153 PUD inpatients, correlation analysis, factor analysis, t-test, and Generalizability Theory analysis (including generalizability study and decision study, ie. G-study and D-study) were used to assess the validity, reliability, and responsiveness of the scale., Results: When the popular scale health survey short form (SF-36) was used as the standard, correlation and factor analysis confirmed good construct validity and criterion-related validity of QLICD-PU. Except for the social domain (0.62), the internal consistency α of all domains is higher than 0.70. The overall score and the test-retest reliability coefficients (Pearson r and intra-class correlation ICC) in all domains are higher than 0.80 (0.77 in the social domain). After treatments, the overall score and scores of all domains have statistically significant changes (P < 0.01), except for social impact and sexual function scores. The SRM (Standardized response mean) of domain-level scores ranges from 0.34 to 1.03. The G coefficient and reliability index (Ф coefficient) further confirm the reliability of the scale through more accurate variance components and decision-making information about changes in the number of items., Conclusions: The QLICD-PU can be used as a useful measurement to assess the quality of life of PUD patients with good psychometric characteristics and multiple advantages.

Objective: We compare the reliability and validity of the Short Form 36 (version 1, SF-36) and the Short Form 12 (version 1, SF-12) in adolescence, the period of life when a child develops into an adult, i.e., the period from puberty to maturity terminating legally at the age of majority (10-19 years), thus supplying evidence for the selection of instruments measuring the quality of life (QOL) and decision-making processes of adolescents in China., Methods: Stratified cluster random sampling was adopted according to geographical location, and the SF-36 was administered to assess QOL. The Pearson correlation coefficient was used to show correlation. Cronbach's alpha and construct reliability (CR) were used to evaluate the reliability of SF-36 and SF-12, while criterion validity and average variance extracted (AVE, convergence validity) were used to evaluate validity. Confirmatory factor analysis was used to calculate the load factors for the items of the SF-36 and SF-12, then to obtain the CR and AVE. The Semejima grade response model (logistic two-parameter module) in item response theory was used to estimate item discrimination, item difficulty, and item average information for the items of the SF-36 and SF-12., Results: 19,428 samples were included in the study. The mean age of respondents was 14.78 years (SD = 1.77). Reliability of each domain of the SF-36 was better than for the corresponding domain of the SF-12. The domains of PF, RP, BP, and GH in SF-36 had good construct reliability (CR > 0.6). The criterion validities of some domains of the SF-36 were a little higher in some corresponding dimensions of the SF-12, except for PCS. The convergence validities of the SF-12 were higher than the SF-36 in PF, RP, BP, and PCS. The items of BP, SF, RP, and VT in the SF-12 had acceptable discrimination of items that were higher than in the SF-36. The items' average amounts of information on BP, VT, SF, RE, and MH in the SF-36 and SF-12 were poor., Conclusion: Two component (PCS and MCS) measurements of the SF-12 appeared to perform at least as well as the SF-36 in cross-sectional settings in adolescence, but the reliability and validity of the 8 domains of the SF-36 were better than those of the SF-12. Some domains, for instance SF and BP, were not suitable for adolescents or need to be studied further.

Objectives: Patient-reported outcome (PRO) measurements used in cancer research can assess a number of health domains. Our primary objective was to investigate which broad types of PRO domains (namely, functional health, symptoms, and global quality of life [QoL]) most frequently yielded significant differences between treatments in randomized controlled trials (RCTs)., Methods: A total of 229 RCTs published between January 2004 and February 2019, conducted on patients diagnosed with the most common solid malignancies and assessed using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, were considered. Studies were identified systematically using literature searches in key electronic databases. Unlike other PRO measurements typically used in RCTs, the scoring algorithm of the multidimensional EORTC QLQ-C30 allowed us to clearly distinguish the 3 broad types of PRO domains., Results: In total, 134 RCTs (58.5%) reported statistically significant differences between treatment arms for at least 1 of the QLQ-C30 domains. Most frequently, differences were reported for 2 or all 3 broad types of PRO domains (78 of 134 trials; 58.2%). In particular, 35 trials (26.1%) found significant differences for symptoms, functional health, and global QoL, 24 trials (17.9%) for symptoms and functional health, 11 trials (8.2%) for functional health and global QoL, and 8 trials (6.0%) for symptoms and global QoL. The likelihood of finding a statistically significant difference between treatment arms was not associated with key study characteristics, such as study design (ie, open-label vs blinded trials) and industry support., Conclusions: Our findings emphasize the importance of a multidimensional PRO assessment to most comprehensively capture the overall burden of therapy from the patients' standpoint., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Chinese economic development has led to a significant rise in internal migration over the last 20 years, including large numbers of elderly. When elderly Chinese people migrate, they still register their residency to their place of origin and often do not register with the new administrative office at the destination due to the household registration (hukou) system in China. Thus, most of these migrant elderly do not receive full social services, possibly leading to poor subjective well-being. This study aims to qualitatively examine the level of subjective well-being and its determinants among migrants and local elderly in Dongguan City of Guangdong province, one of the most rapid economically developing areas in China. We also present the results of in-depth interviews among 27 elderly, 15 elderly migrants and 12 local elderly living in Dongguan. The results reveal that the overall subjective well-being of the two groups were good. Most migrants believed their well-being had remained stable or even improved over time due to family reunion and a better physical environment. Elderly's most valuable needs and the main reason of migration is family reunion; however, inadequacy of social support, including community support and government support (e.g., gift during holiday season, free health examination, healthcare expenditure reimbursement), cannot be neglected for maintaining a good level of well-being. The well-being of migrant elderly can be further enhanced by promoting social services and welfare, recreational activities, and enhancing healthcare reimbursement in their new home.

Quality of life is an important outcome indicator to evaluate whether treatment is successful or not. Chronic gastritis leads to ongoing deterioration of subjectively perceived quality of life. There are several generic measures, but they are not developed particularly to assess chronic gastritis problems. The Quality of Life Instruments for Chronic Diseases-Chronic Gastritis (QLICD-CG V2.0) questionnaire is a 39-item, multi-dimensional, self-report instrument to assess chronic gastritis patients' perception of their health related quality of life in four domains. The instrument was developed in China. The current study aimed to evaluate the psychometric properties of the QLICD-CG V2.0. 194 patients with chronic gastritis were enrolled from 4 hospitals in China. The QLICD-CG V2.0 was administered to patients by trained research assistants. In addition, their demographic characteristics were also recorded. The psychometric testing included construct validity, convergent validity, discriminant validity, test-retest, and responsiveness. The results showed good internal consistency and acceptable floor and ceiling effects (Cronbach's alpha range from 0.80 to 0.93). CFA showed that the instrument structure has a reasonable fitness (RMSEA = 0.063, 95%CI = [0.057 0.079], CFI = 0.93, GFI = 0.95, SRMR = 0.028). The convergent validity was considered appropriate, with 38 of the 39 items correlated stronger with their assigned scale than a competing scale, except for GPS1. Known groups comparisons showed that the QLICD-CG V2.0 discriminated well between subgroups on the basis of gender, marriage status, and economy status, thus providing evidence of discriminative validity. Convergent validity testing revealed that the QLICD-CG V2.0 domain scores correlated significantly with SF-36 dimension scores, which ranged from 0.21 to 0.58. Test-retest coefficients were satisfactory. A majority of intraclass correlation coefficients were above 0.70, except the psychological domain (0.60) and the items of social support/security (0.61). Responsiveness was tested on 157 patients. Significant differences were found on all QLICD-CG V2.0 domains, between baseline responses and after a treatment, except for the items of appetite and sleep. Robust sensitivity to change was observed. The QLICD-CG V2.0 appears to be a valid and reliable instrument to measure QOL in chronic gastritis patients. Scores were reproducible., Competing Interests: The authors have declared that no competing interests exist.

Background: Generic assessments are less responsive to subtle changes due to specific diseases, making it challenging to fully understand the impact of pulmonary tuberculosis (TB) on patient's quality of life (QOL)., Methods: We applied programmed decision procedures and theories on instrument development to develop the scale. Two hundred patients with pulmonary TB participated in measuring QOL three times before and after treatments. We assessed the validity, reliability, and responsiveness of QLICD-PT using correlation analysis, factor analysis, multi-trait scaling analysis, randomized block analyses of variance with Least Significant Difference post-hoc tests., Results: We composed QLICD-PT with 3 domains (28 items) for general QOL and 1 pulmonary TB specific domain (12 items). Correlation and factor analysis confirmed good structure validity and criterion-related validity when using Chinese version of the Medical Outcomes Short-Form Health Survey (SF-36) as a criterion. The internal consistency of α values were higher than 0.70. The score changes after treatment were of statistical significance for the overall scale, physical domain and specific domain with effect size ranging from 0.32 to 0.72. No floor effects but small ceiling effects were observed at domain level., Conclusions: As the first pulmonary TB-specific QOL scale developed by a module approach in Chinese, QLICD-PT has an acceptable degree of validity, reliability and responsiveness, and can be used to measure the life quality of PT patients specifically and sufficiently.

Background: The Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scale, a leukemia-specific instrument for determining the health-related quality of life (HRQOL) in patients with leukemia, had been developed and validated, but there have been no reports on the development of a simplified Chinese version of this scale. This is a new exploration to analyze the reliability of the HRQOL measurement using multivariate generalizability theory (MGT). This study aimed to develop a Chinese version of the FACT-Leu scale and evaluate its reliability using MGT to provide evidence to support the revision and improvement of this scale., Methods: The Chinese version of the FACT-Leu scale was developed by four steps: forward translation, backward translation, cultural adaptation and pilot-testing. The HRQOL was measured for eligible inpatients with leukemia using this scale to provide data. A single-facet multivariate Generalizability Study (G-study) design was demonstrated to estimate the variance-covariance components and then several Decision Studies (D-studies) with varying numbers of items were analyzed to obtain reliability coefficients and to understand how much the measurement reliability could be vary as the number of items in MGT changes., Results: One-hundred and one eligible inpatients diagnosed with leukemia were recruited and completed the HRQOL measurement at the time of admission to the hospital. In the G-study, the variation component of the patient-item interaction was largest while the variation component of the item was the smallest for the four of five domains, except for the leukemia-specific (LEUS) domain. In the D-study, at the level of domain, the generalizability coefficients (G) and the indexes of dependability (Ф) for four of the five domains were approximately equal to or greater than 0.80 except for the Emotional Well-being (EWB) domain (>0.70 but <0.80). For the overall scale, the composite G and composite Ф coefficients were greater than 0.90. Based on the G coefficient and Ф coefficient, two decision options for revising this scale considering the number of items were obtained: one is a 37-item version while the other is a 45-item version., Conclusion: The Chinese version of the FACT-Leu scale has good reliability as a whole based on the results of MGT and the implementation of MGT could lead to more informed decisions in complex questionnaire design and improvement.

This study aimed to develop and validate the Simplified Chinese Version of the Quality of Life Questionnaire for Hepatocellular Carcinoma (the QLQ-HCC18). It was developed by the strict translation procedure of EORTC guidelines, and the psychometrics were evaluated on a sample of 114 patients. The internal consistency Cronbach's α were greater than 0.60 for all domains (exception of Jaundice 0.38), and all test-retest reliability coefficients were greater than 0.80. Four out of eight domains had statistically significant changes with effect size standardized response mean (SRM) ranging from 0.31 to 0.73. The Simplified Chinese version of QLQ-HCC18 demonstrates good validity, reliability, and responsiveness.

Purpose: This paper is aimed to develop the irritable bowel syndrome (IBS) scale of the system of Quality of Life Instruments for Chronic Diseases (QLICD-IBS) by the modular approach and validate it by both classical test theory and generalizability theory., Methods: The QLICD-IBS was developed based on programmed decision procedures with multiple nominal and focus group discussions, in-depth interview, and quantitative statistical procedures. One hundred twelve inpatients with IBS were used to provide the data measuring QOL three times before and after treatments. The psychometric properties of the scale were evaluated with respect to validity, reliability, and responsiveness employing correlation analysis, factor analyses, multi-trait scaling analysis, t tests and also G studies and D studies of generalizability theory analysis., Results: Multi-trait scaling analysis, correlation, and factor analyses confirmed good construct validity and criterion-related validity when using SF-36 as a criterion. Test-retest reliability coefficients (Pearson r and intra-class correlation (ICC)) for the overall score and all domains were higher than 0.80; the internal consistency α for all domains at two measurements were higher than 0.70 except for the social domain (0.55 and 0.67, respectively). The overall score and scores for all domains/facets had statistically significant changes after treatments with moderate or higher effect size standardized response mean (SRM) ranging from 0.72 to 1.02 at domain levels. G coefficients and index of dependability (Ф coefficients) confirmed the reliability of the scale further with more exact variance components., Conclusions: The QLICD-IBS has good validity, reliability, responsiveness, and some highlights and can be used as the quality of life instrument for patients with IBS.

Background: The assessment of Health Related Quality of Life (HRQOL) has been applied as a significant outcome indicator for patients with chronic diseases. No HRQOL study, however, has looked at HRQOL in patients with chronic gastritis and peptic ulcers. This paper focuses on comparing HRQOL in patients with chronic gastritis and peptic ulcers and examining the factors that influence the HRQOL of such patients. Results can be used for making decisions in clinical trials as well as aiding individual management and preventive care of these diseases., Methods: The Chinese version of the SF-36 (CSF-36) was administered twice to 244 patients with chronic gastritis and peptic ulcers. Mean scores across the two disease groups were compared using t-tests, change over time was analyzed with paired samples t-tests, and factors predicting HRQOL were investigated using the univariate general linear model., Results: The mean domain scores of patients with chronic gastritis were lower than those for patients with peptic ulcers, with the exception of physical functioning. Both groups had lower HRQOL compared with population norms. Mean domain scores increased after treatment in both groups. HRQOL in patients with these two chronic diseases differed by age, education level, marriage, income, and gender, but their explanatory power was relatively low., Conclusion: Quality of life of patients with chronic gastritis was lower than that of patients with peptic ulcers, which was lower than population norms. Quality of life in both patients groups was associated with socio-demographic risk factors.

Background: Quality of life (QOL) for patients with coronary heart disease (CHD) is now concerned worldwide with the specific instruments being seldom and no one developed by the modular approach., Objectives: This paper is aimed to develop the CHD scale of the system of Quality of Life Instruments for Chronic Diseases (QLICD-CHD) by the modular approach and validate it by both classical test theory and Generalizability Theory., Methods: The QLICD-CHD was developed based on programmed decision procedures with multiple nominal and focus group discussions, in-depth interview, pre-testing and quantitative statistical procedures. 146 inpatients with CHD were used to provide the data measuring QOL three times before and after treatments. The psychometric properties of the scale were evaluated with respect to validity, reliability and responsiveness employing correlation analysis, factor analyses, multi-trait scaling analysis, t-tests and also G studies and D studies of Genralizability Theory analysis., Results: Multi-trait scaling analysis, correlation and factor analyses confirmed good construct validity and criterion-related validity when using SF-36 as a criterion. The internal consistency α and test-retest reliability coefficients (Pearson r and Intra-class correlations ICC) for the overall instrument and all domains were higher than 0.70 and 0.80 respectively; The overall and all domains except for social domain had statistically significant changes after treatments with moderate effect size SRM (standardized response mea) ranging from 0.32 to 0.67. G-coefficients and index of dependability (Ф coefficients) confirmed the reliability of the scale further with more exact variance components., Conclusions: The QLICD-CHD has good validity, reliability, and moderate responsiveness and some highlights, and can be used as the quality of life instrument for patients with CHD. However, in order to obtain better reliability, the numbers of items for social domain should be increased or the items' quality, not quantity, should be improved.

Purpose: To develop and validate a quality of life (QOL) instrument for patients with colorectal cancer, QLICP-CR., Methods: Using the programmed decision method and the theory in instrument development, the QLICP-CR was developed and evaluated based on the data measuring QOL thrice from a sample of 110 inpatients of colorectal cancer., Results: The internal consistency α and the test-retest reliability for the overall scale and domains are above 0.70 and 0.79, respectively; the score differences between pretreatment and posttreatment have statistical significance for three domains and the overall instrument, with higher Standardized Response Mean of 0.61, 0.62, 1.33, and 0.80., Conclusions: The QLICP-CR is of good validity, reliability, and responsiveness.

Quality of life for patients with head and neck is now concerned worldwide, but the available QOL instruments are seldom and lack of Chinese culture. Therefore, this paper aimed to develop and validate a QOL instrument for patients with head and neck cancer, QLICP-HN. Using the programmed decision methods and the theory in instrument development, the QLICP-HN was developed and evaluated based on the data measuring QOL three times before and after treatment from a sample of 133 in-patients of head and neck cancer. The psychometric properties of the scale were evaluated by indicators such as validity and reliability coefficients: Cronbach α, Pearson r, standardized response mean. The statistical methods included Pearson correlation, multi-trait scaling analysis, factor analysis, cluster analysis and paired t test. The internal consistency α for the overall scale and domains is above 0.70 with the exception of the social function (0.65) and common symptom and side effect (0.66); the test-retest reliability for each domain and the overall scale is higher than 0.80; most correlation coefficients between each item and its domain are above 0.40; the scores differences between pre-treatment and post-treatment have statistical significance for three domains of physical, psychological, the specific, and the overall instrument, with higher SRM of 0.33, 0.59, 0.44 and 0.53. The QLICP-HN is of good validity, reliability and responsiveness, and can be used to assess quality of life for patients with head and neck cancer in China., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Goals: A simplified Chinese version of EORTC QLQ-H&N35 was developed using strict translation procedures according to EORTC translation guidelines. Psychometric properties were evaluated., Patients and Methods: Three instruments (QLQ-H&N35, QLICP-HN, and FACT-H&N) were used in a sample of 133 patients with head and neck cancer at the time of their admission to the hospital. Each patient was assessed for the second time 1-2 days after hospitalization so that the test-retest reliability could be calculated. A sub-sample of patients was sampled and measured for the third time at discharge in order to evaluate the responsiveness., Results: Correlation analysis among domains and items of the three instruments showed good construct validity and criterion-related validity. Comparisons of QLQ-H&N35 between treatment groups and age groups supported clinical validity. The internal consistency reliability measured by Cronbach's coefficient α was greater than 0.70 for all multi-item domains, and test-retest reliability coefficients for all domains were greater than 0.80, ranging from 0.88 to 0.95. Score changes between pre- and post-treatment were observed in 6 out of 18 domains, with effect size SRM ranging from 0.27 to 0.87., Conclusions: The simplified Chinese version of QLQ-H&N35 demonstrates good validity, reliability, and responsiveness and can be used to measure QOL for Chinese patients with head and neck cancer.

Aims: This paper is aimed to develop and validate the hypertension scale of the system of Quality of Life Instruments for Chronic Diseases, QLICD-HY., Methods: The QLICD-HY instrument was developed based on programmed decision procedures with multiple nominal and focus group discussions and pilot testing. A total of 157 inpatients with hypertension were used to provide the data measuring QOL three times before and after treatment. The psychometric properties of the scale were evaluated with respect to validity, reliability and responsiveness employing correlation and factor analyses, and t-tests., Results: Correlation and factor analyses confirmed good construct validity and criterion-related validity when using Short Form (36) Health Survey (SF-36) as a criterion. Test-retest reliability coefficients (Pearson r and intra-class correlation (ICC)) for the overall instrument score and all domains except for the hypertension-specific domain (SPD) (0.75) were higher than 0.80 with a range of 0.75-0.91; the internal consistency α for all domains except for the hypertension-specific domain (0.66) was higher than 0.70. The overall score and scores for most facets within each domain except for the social domain (SOD) had statistically significant changes (t-tests) after treatment with moderate effect sizes., Conclusion: QLICD-HY has good validity, reliability, responsiveness and can be used as the quality-of-life instrument for patients with hypertension., (© 2011 Elsevier Ltd. All rights reserved.)

Objectives: This study aimed to develop and validate the simplified Chinese version of the EORTC Quality of Life Questionnaire for Colorectal Cancer, QLQ-CR38., Methods: It was developed by the strict translation procedure of EORTC translation guidelines, including translation, back translation, a pilot test and a cultural adaptation. Three instruments (QLQ-CR38, Quality of Life Instruments for Cancer Patients-Colorectal Cancer, and Functional Assessment of Cancer Therapy-Colorectal) were used on a sample of 110 patients with colorectal cancer at the time of their admission to the hospital and 1-2 days after hospitalization, and a subsample of patients was measured a third time at discharge. The psychometric properties were evaluated by correlational analysis, multi-trait scaling analysis, factor analysis, and t tests., Results: Multi-trait scaling analysis and correlation analysis among domains and items of the three instruments showed good construct validity and criterion-related validity. Cronbach's α and the test-retest reliability coefficients were greater than 0.70 for all domains (except chemotherapy side effects, 0.44 and 0.60, respectively). All domains had statistically significant changes after treatment with the standardized response mean ranging from 0.44 to 2.47., Conclusions: The simplified Chinese version of QLQ-CR38 has good validity, reliability, and responsiveness and can be used to measure the quality of life of Chinese patients with colorectal cancer., (Copyright © 2012 S. Karger AG, Basel.)

Aim: Our goal was to develop a self-administered quality of life scale for patients with drug addiction/dependence (QOL-DA) and compare it with the SF-36 and the WHOQOL-100., Methods: Employing theory and methodology of rating scale construction, a self-administered quality of life instrument for individuals with drug dependence QOL-DA was developed and evaluated utilizing responses from 212 drug-dependent subjects at the Kunming Municipal Mandatory Detoxification and Rehabilitation Center in China. Quality of life was measured using the SF-36, WHOQOL-100 and QOL-DA three times during the detoxification., Results: Test-retest reliability in the domains of physical function, psychological function, social function and toxicity were 0.82, 0.64, 0.78, and 0.76, respectively. Cronbach's coefficient α for the 4 domains was 0.87, 0.89, 0.93 and 0.86, respectively. Correlations and factor analysis showed good construct validity. Criterion-related and convergent validity was confirmed by using the SF-36 and the WHOQOL-100 simultaneously. The instrument does show the change in QOL after two weeks of detoxification with higher standardized response mean higher than that of SF-36 and WHOQOL-100., Conclusion: The instrument developed has good validity, reliability and better responsiveness than instruments currently used, and can be employed effectively to measure the quality of life of individuals with drug dependence., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Context: Quality of life (QOL) for patients is now a worldwide concern, but there are few specific instruments developed by modular approach to measure outcomes in chronic diseases., Objectives: This study aimed to develop and validate the System of Quality of Life Instruments for Chronic Diseases--General Module (QLICD-GM)., Methods: Based on the World Health Organization's definition of QOL and programmed decision procedures, the QLICD-GM was developed using focus group discussions, pilot tests of 201 cases, and field tests of 620 cases representing seven different chronic diseases. The number of items in the final version was reduced to 30 from a 73-item pool, and the psychometric properties of the scale were evaluated by indicators, such as validity and reliability coefficients, standardized response mean, and statistical methods of correlational analysis, t-tests, and structural equation modeling., Results: Correlational and structural equation model analyses confirmed good construct validity with root mean square error of approximation of 0.0606, nonnormed fit index of 0.941, and comparative fit index of 0.947. Test-retest reliability coefficients for all domains and facets were higher than 0.70, with a range of 0.71-0.92, and the internal consistency alphas for most domains and facets were higher than 0.65 (ranging from 0.52 to 0.89). All domains and overall scores of the QLICD-GM had a statistically significant change after treatment, with moderate effect size., Conclusion: The QLICD-GM has good validity, reliability, and better responsiveness compared with the SF-36® Health Survey and can be used as the general module for chronic diseases., (Copyright © 2011 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Objective: To develop a self-administered quality of life instrument for patients with liver cancer., Methods: The programmed decision procedure, the theory and methodology in developing rating scale were used to establish the instrument. On the basis of the data from 105 liver cancer patients, the psychometric properties of the scale were evaluated by indicators of validity, reliability coefficients, and statistical methods like structural equation modeling., Results: The test-retest coefficients for physical, psychological, symptom/side effects, social domains, and the overall scale are 0.76, 0.86, 0.71, 0.80, and 0.84, respectively. The α coefficients for the above 4 domains are 0.78, 0.81, 0.75, and 0.68, respectively. The correlation analysis and the structural equation model showed good construct validity. The criterion-related was confirmed by using the functional living index-cancer simultaneously. The scale can reflect the changes of patients' quality of life after treatment., Conclusions: The instrument is of good validity, reliability, and responsiveness and has been broadly used in China.

Goals: To develop and validate a quality of life (QOL) instrument for patients with breast cancer, QLICP-BR, which is one of the system of QOL instruments for cancer patients in China., Methods: Using the programmed decision methods of instrument development, the quality of life instrument for cancer patients-breast cancer (QLICP-BR) with considering Chinese cultural background was developed, and evaluated on the data from 186 inpatients with breast cancer. The statistical methods used in this research included statistical description, Pearson correlation, factor analysis, and paired t test., Results: The test-retest reliability for the overall scale and five domains are all above 0.75. Internal consistency alpha for each domain is higher than 0.65 except social domain (0.58). Most correlation coefficients between each item and it's domain are above 0.60. The scores differences between pretreatment and post-treatment for overall scale, general module, physical domain, psychological domain and social domain have statistical significance., Conclusions: The QLICP-BR is of good validity, reliability, and reasonable responsiveness, and can be used to assess quality of life for patients with breast cancer in China.

Purpose: To validate the simplified Chinese version of the EORTC QLQ-LC43 for lung cancer patients., Methods: The simplified Chinese version of the QLQ-LC43 was used to measure quality of life (QOL) of 181 in-patients with lung cancer at three time points before and after treatment. Psychometric properties of the instrument were evaluated based on the QOL data collected from the patients using correlation analysis, factor analysis and paired t-test., Results: The test-retest reliability r for most domains was higher than 0.60 with a range from 0.53 to 0.80. The internal consistency alpha for all domains was higher than 0.65 except for cognitive functioning (0.32). Correlation analysis and factor analysis demonstrated good construct validity. The instrument reflected the differences in QOL scores among different age groups, indicating known-groups validity, and revealed good criterion-related validity when FACT-L was used as the criterion. The instrument detected changes of QOL with higher standardized response mean for the patients before and after treatment., Conclusion: The Chinese version of QLQ-LC43 can be used to measure QOL for Chinese patients with lung cancer with good validity, reliability and responsiveness.

Using the structured group methods (nominal and focus group) and the theory in instrument development, the quality of life instrument for lung cancer (QLICP-LU) with Chinese cultural background was developed, and evaluated based on the data from a sample of 85 in-patients of lung cancer. Statistical methods used were correlation analysis, factor analysis and paired t-test, etc. The results showed that test-retest reliability of the overall scale was 0.78, and test-retest reliability and internal consistency alpha for most domains were higher than 0.70; correlation and factor analysis demonstrated good construct validity; criterion-related validity were confirmed given FACT-L and QLQ-LC43 (QLQ-C30 plus QLQ-LC13) as the criterions; statistically significant changes were found for each domain and the overall scale with standardized response mean SRM being greater than 0.80 except for the social function domain. We conclude that the QLICP-LU can be used to measure QOL for patients with lung cancer with better validity, reliability and responsiveness in China.

Based on World Health Organization (WHO)'s definition of Quality of Life (QOL) and programmed decision procedures, we developed a general module of the System of Quality of Life Instruments for Cancer Patients (QLICP-GM) utilizing focus group discussions, pilot tests of 448 cases and field tests of 600 cases of 5 different cancer patients. The number of items in the final version was reduced to 32 from a 78-item pool. The psychometric properties of the scale were evaluated by indicators such as validity and reliability coefficients, SRM, and statistical methods of correlational analysis, t tests, and structural equation modeling. Correlational and structural equation model analyses indicate good construct validity with RMSEA 0.086, NNFI 0.947 and CFI 0.961. Good criterion-related validity was found when FACT-G was used as the criterion. The test-retest reliability for all domains and the overall scale is above 0.85; the internal consistency alpha for each domain is higher than 0.70 except of the social function; alpha and the split-half reliability of the overall scale is 0.88 and 0.93, respectively. The pre-post changes of QOL scores are of statistical significances in 3 domains of physical function, psychological function, common symptoms and side effects, and the overall instrument, with standardized response mean ranging from 0.16 to 0.67. Equivalence tests showed nonequivalence on quality of life score changes of these domains and the overall instrument. Our study shows that the QLICP-GM has good validity, reliability, responsiveness, and can be used as the general module for cancer patients in China., (Copyright 2007 Wiley-Liss, Inc.)

The simplified Chinese version of the FACT-B was evaluated by QOL data measured from 376 patients with breast cancer. The results showed that test-retest reliability for five domains: physical well-being, social/family well-being, emotional well-being, functional well-being, additional concerns, and the overall scales and trial outcome index were 0.82, 0.85, 0.91, 0.86, 0.90, 0.84 and 0.91, 0.89 respectively. The internal consistency alpha for the five domains mentioned above were 0.85, 0.82, 0.84, 0.84 and 0.59 respectively. Correlation analysis, factor analysis and structural equation model showed good construct validity. Criterion-related validity was also confirmed using QLICP-BR as a criterion. The instrument can find the change of QOL for cancer patients after treatment. It's concluded that the simplified Chinese version of FACT-B can be used to measure QOL for Chinese patients with breast cancer with good validity, reliability and responsiveness.

A Simplified Chinese version of the EORTC QLQ-BR53 was evaluated using responses from 233 patients with breast cancer in China by assessing the construct and criterion-related validity, internal consistency and test-retest reliability, and responsiveness as measured by score changes of the scales. Internal consistency reliability measured by Cronbach's coefficient alpha is greater than 0.75 for most multi-item scales except cognitive functioning (0.41) and breast symptoms (0.71). Test-retest reliability coefficients for all domains are greater than 0.80 with the exception of physical functioning (0.65), social functioning (0.75), appetite loss (0.75), diarrhea (0.72), and body image (0.72). Correlation and factor analysis among domains and items showed good construct validity for both QLQ-C30 and QLQ-BR23. Score changes over time were observed in most domains except emotional functioning, global health status/QOL, dyspnoea, constipation, diarrhea, financial difficulties, sexual functioning, sexual enjoyment, and breast symptoms. Therefore, the Simplified Chinese version of QLQ-BR53 shows reasonable validity, reliability, and responsiveness and can be used to measure QOL for Chinese patients with breast cancer.

A Simplified Chinese version of the FACT-L was evaluated using responses from 181 patients with lung cancer in China by assessing the construct, discriminative and criterion-related validity, internal consistency, test-retest reliability, and responsiveness as measured by score changes of the scales. Correlation and factor analysis among domains and items showed good construct validity, correlation analysis of domain scores between FACT-L and Quality of Life Instruments for Cancer Patients-Lung cancer (QLICP-LU) displayed good criterion-related validity, and comparison of two age groups demonstrated discriminative validity. Test-retest reliability and Internal consistency coefficients for all domains were greater than 0.75 with the exception of the domain of additional concerns (alpha=0.56). Score changes over time were statistically significant in the overall scale and all domains: standardized response mean (SRM) for physical well-being is 1.56, social/ family well-being 0.70, emotional well-being 0.93, and functioning well-being 1.51. Therefore, the Simplified Chinese version of FACT-L can be used to measure quality of life (QOL) for Chinese patients with lung cancer with good validity, reliability, and responsiveness.

Background The quality of life of patients with nephrotic syndrome requires a lot of focus, and improvements. A relevant scale can be used to measure it, but there is no nephrotic syndrome-specific quality of scale. Objective To develop a Quality of Life Instruments for Chronic Diseases-Nephrotic Syndrome〔QLICD-NS (V2.0) 〕 combined with QLICD-GM (V2.0), then verify it using the classical test theory. Methods From 2017 to 2021, an item pool was established according to literature review and the results of a semi-structured questionnaire, then the items were screened in accordance with a pre-test and importance score rated by physicians and patients, after that, the draft of the QLICD-NS (V2.0) was developed. The draft version was tested using onsite interview and questionnaire survey in nephrotic syndrome patients treated in Department of Nephrology, the Affiliated Hospital of Guangdong Medical University from March to November 2021. The first measurement was conducted on the day of admission, the second measurement was conducted with some of the patients, and the third measurement was conducted on the day of discharge. The coefficient of variation, correlation coefficient and Cronbach's α, factor analysis and classical test theory were used to evaluate QLICD-NS (V2.0) . Results The QLICD-NS (V2.0) contains 15 items, belonging to three domains of clinical symptoms, adverse drug reactions and psychological effects. The Cronbach's α measuring the split-half reliability was greater than 0.7 for the scale and each of the three domains. With the Chinese version of SF-36 as the calibration standard, the domains of the QLICD-NS (V2.0) were highly correlated with their counterpart domains of the Chinese version of SF-36. The standardized response mean was greater than 0.80 for all domains and items (except for the cognition and social support items), indicating that the responsiveness of the QLICD-NS (V2.0) was good. Scanning the QR code in the text can obtain the detailed evaluation of the scale. Conclusion The QLICD-NS (V2.0) compiled by us includes 15 items, and has proven with good reliability, validity and responsiveness.

Scale assessment for irritable bowel syndrome (IBS) has been widely implemented in clinical practice, how to choose an appropriate assessment tool is very important. In view of this, we used literature research methodology to search patient-reported outcomes and disease-specific health-related quality of life instruments for IBS, summarized their main contents and psychometric properties, then put forward recommendations on the selection of the instruments. A total of 37 commonly used instruments for IBS were retrieved, which have proven to have good reliability, validity and responsiveness, and can be better applied in clinical practice. We suggest medical professionals and researchers choose an assessment instrument for IBS according to the purpose and content of their research.

ObjectiveTo analyze the quality of life and related factors in patients with depression， and to provide evidence for formulating the corresponding measures to improve the patients' quality of life.MethodsA total of 117 inpatients who met the International Classification of Diseases， tenth edition（ICD-10） for depression were selected in Central People's Hospital of Zhanjiang， Affiliated Hospital of Guangdong Medical University and Guangdong 999 Brain Hospital from November 19， 2018 to September 7， 2019. The values of patients' clinical objective indicators consisted of routine blood test， routine urine examination， blood biochemical tests and blood gas analysis were collected by reviewing their medical records， and all subjects were assessed using Quality of Life Instruments for Chronic Diseases-Depression V2.0 ［QLICD-DE（V2.0）］. Simple correlation analysis was used to explore the correlation between the QLICD-DE （V2.0） scores and various clinical objective indicators， and multiple linear regression was adopted to further screen factors affecting quality of life of patients with depression.ResultsSimple correlation analysis suggested that QLICD-DE （V2.0） total score was positively correlated with total protein and platelet distribution width in patients with depression （r=0.198， 0.281， P

Coronary heart disease (CHD) is a common and frequent disease with a long and incurable course, and the quality of life of patients is severely reduced. This study was to develop and validate a quality of life scale for patients with CHD based on the Chinese context. Methods: The scale QLICD-CHD (V2.0) was developed based on the QLICD-CHD (V1.0), using a programmed decision procedures. Based on the data measuring QoL 3 times before and after treatments from 189 patients with CHD, the psychometric properties of the scale were evaluated with respect to validity, reliability and responsiveness employing correlation analysis, multi-trait scaling analysis, structural equation modeling, t-test and also G-study and D-study of generalizability theory analysis. The SF-36 scale was used as the criterion to evaluate the criterion-related validity. Paired t tests were conducted to evaluate the responsiveness on each domain/facet as well as the total of the scale, with Standardized Response Mean (SRM) being calculated. Results: The QLICD-CHD (V2.0) has been developed with 42 items in 4 domains. The Cronbach's α of the general module, the specific module and the total scale were 0.91, 0.92 and 0.91 respectively. The overall score and the test-retest reliability coefficients in all domains are higher than 0.60, except for the specific module. Correlation and factor analysis confirmed good construct validity and criterion-related validity. After treatments, the overall score and score of all domains have statistically significant changes (P< 0.01). The SRM of domain-level score ranges from 0.27 to 0.50. Generalizability Theory further confirm the reliability of the scale through more accurate variance component studies. Conclusion: The QLICD-CHD (V2.0) could be used as a useful instrument in assessing QoL for patients with CHD, with good psychometric properties. [ABSTRACT FROM AUTHOR]

Purpose: Coronary heart disease (CHD) is difficult to cure, so more attention should be paid to improving patients' health-related quality of life (HRQoL). This paper focuses on identifying factors that affect HRQoL.Patients and Methods: Overall, 189 in-patients with coronary heart disease were investigated at the Affiliated Hospital of Guangdong Medical University between 2015 and 2016. The scale Quality of Life Instruments for Chronic Diseases-Coronary heart disease (QLICD-CHD V2.0) was used to evaluate HRQoL and collect demographic information. Medical records were applied to collect patients' clinical indicators. A simple correlation analysis, Student's t-test, and a one-way analysis of variance were first performed to filter factors that might associate with HRQoL, and multiple linear regression was applied to finally identify related factors.Results: Findings from multiple linear regression showed that the total score was related to family economy, treatment, indirect bilirubin, and albumin with regression coefficient B=5.209, − 6.615, 0.378, and 0.548, respectively. The physical functions were related to treatment, albumin, globular proteins, chloride, and red blood cell count with B=− 9.031, 1.000, 0.612, 1.320, and 5.161, respectively. The psychological function was in association with family economy, clinical course, serum phosphorus, and percentage of lymphocyte population with B=7.487, 6.411, − 16.458, and 0.090, respectively. The social function was associated with family economy, blood urea nitrogen, serum creatinine, and platelet distribution width with B=7.391, 1.331, − 0.060, and − 0.929, respectively. The special module was in association with treatment, indirect bilirubin, and serum calcium with B=− 7.791, 0.414, and 23.017, respectively.Conclusion: Clinical indicators including albumin, globular proteins, chloride, red blood cell count, serum phosphorus, percentage of lymphocyte population, blood urea nitrogen, serum creatinine, platelet distribution width, indirect bilirubin, and serum calcium, as well as socio-demographic factors including the family economy, clinical course, and treatment, may affect coronary heart disease patients' HRQoL. [ABSTRACT FROM AUTHOR]