Development and validation of the system of quality of life instruments for cancer patients: colorectal cancer (QLICP-CR).

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.

Development and validation of a simplified chinese version of EORTC QLQ-CR38 to measure the quality of life of patients with colorectal cancer.

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.

Development and validation of the system of quality of life instruments for cancer patients: breast cancer (QLICP-BR).

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.

A retrospective study of lymphatic transverse rectus abdominis myocutaneous/deep inferior epigastric perforator flaps for breast cancer treatment-induced upper-limb lymphoedema.

Breast cancer-related lymphoedema (BCRL) is a common and intractable complication. To evaluate the possible complications of using lymphatic transverse rectus abdominis myocutaneous/deep inferior epigastric perforator (TRAM/DIEP) flaps for breast reconstruction and BCRL treatment, 20 patients with moderate or severe BCRL were retrospectively enrolled between November 2012 and October 2014. 10 patients had undergone lymphatic TRAM/DIEP flap surgery were assigned to the surgery group. 10 patients unwilling to undergo reconstruction were assigned to the physiotherapy group treated with traditional physical therapy. Upper-limb movement and circumference were measured and patients' subjective assessment was assessed using a questionnaire. In the surgery group, all flaps were successfully transferred. BCRL in 8 patients was improved by one level. The upper-limb circumference returned to normal in 1 case, and only 1 patient did not improve. In the physiotherapy group, a slight improvement was noted in 6 patients and unchanged in four cases. From the questionnaires, patients underwent lymphatic TRAM/DIEP flap surgery reported a significantly greater improvement in the affected limb (p < 0.05). In the physiotherapy group, the limb subjective did not improve as well as in the surgery group. Lymphatic TRAM/DIEP is a safe and effective option for patients who suffer from post-mastectomy lymphoedema.

Levonorgestrel Inhibits Human Endometrial Cell Proliferation through the Upregulation of Gap Junctional Intercellular Communication via the Nuclear Translocation of Ser255 Phosphorylated Cx43.

OBJECTS: To assess whether LNG exerts antiproliferation effects on human endometrial cells through changes of GJIC function and the phosphorylated Cx43. METHODS: Cell proliferation and apoptosis of human endometrial stromal cells (HESCs) and glandular cells (HEGCs) treated with LNG in a dose- and time-dependent manner. GJIC change and further total Cx43 and serine 368 and 255 phosphorylated Cx43 were measured. RESULTS: 5 × 10(-5) mol/L LNG revealed a time-dependent inhibition of cell proliferation and an increase of apoptosis in both HESCs and HEGCs. Furthermore, these cells demonstrated a significant GJIC enhancement upon treatment with 5 × 10(-5) mol/L for 48 hours. The effects of LNG were most noticeable in HESCs rather than in HEGCs. Associated with these changes, LNG induced a relative increase in total Cx43 in a time-dependent manner but not Ser368 phosphorylated Cx43. Moreover, laser scanning confocal microscope confirmed the increased expression of total Cx43 in the cytoplasm and, interestingly, the nuclear translocation of Ser255 phosphorylated Cx43. CONCLUSIONS: LNG likely inhibits the proliferation and promotes apoptosis in HESCs and HEGCs though an increase in gap junction permeability in vitro, which is achieved through the upregulation of Cx43 expression and the translocation of serine 255 phosphorylated Cx43 from the plasma to the nuclear compartment.

[Development of the system of quality of life instruments for cancer patients: stomach cancer (QLICP-ST)].

BACKGROUND & OBJECTIVE: We have previously developed and reported the general module of the system of quality of life instruments for cancer patients (QLICP-GM). This study was to develop and evaluate the quality of life instrument for patients with stomach cancer (QLICP-ST). METHODS: The QLICP-ST was developed using the structured group methods applicable to Chinese populations. The system of QLICP-ST was evaluated by analyzing data from 86 stomach cancer patients using statistical description, Pearson's correlation, exploratory factor analysis, and paired student's t test. RESULTS: The test-retest reliability of the overall scale was 0.98 and that of each domain was greater than 0.90. The internal consistency coefficient alpha of the overall scale was 0.91 and that of each domain was higher than 0.65. Correlation analysis and the exploratory factor analysis revealed good construct validity of the QLICP-ST. Differences of the quality of life scores before and after the treatment in physical domain, psychological domain, common symptom and side effect domain, specific domain and the overall scale were significant. Moreover, the standardized response mean(SRM) of these domains were greater than 0.30. CONCLUSION: The system of QLICP-ST can be used in clinical evaluation of the quality of life for stomach cancer patients with sound validity, reliability and responsiveness.

Psychometric properties of the simplified Chinese version of the EORTC QLQ-BR53 for measuring quality of life for breast cancer patients.

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.

Validation of the simplified Chinese version of the FACT-B for measuring quality of life for patients with breast cancer.

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.

[Development of the general module of the system of quality of life instruments for cancer patients: item selection and structure of the general module].

BACKGROUND & OBJECTIVE: The researches on quality of life (QOL) of cancer patients are concerned worldwide. Two QOL instrument systems for cancer patients, Functional Assessment of Cancer Therapy (FACT) and Quality of Life Questionnaires (QLQ), have been developed and used widely in the US and Europe, but no one has been developed in China. This study was to develop the general module of the system of quality of life instruments for cancer patients (QLICP-GM) used in China. METHODS: The structured group (nominal group and focus group) methods and the qualitative combined quantitative theory and methodology was used to develop rating scales. The items were preliminarily screened, evaluated, and modified. The QOL data of 448 cancer patients were analyzed by the methods of coefficient of variation, factor analysis, clustering analysis, and correlation analysis. RESULTS: QLICP-GM was developed and evaluated. The module, including 32 items, was consisted of 4 domains: physical function, psychologic function, social function, and general symptoms and side effects. CONCLUSION: QLICP-GM possesses a reasonable content validity because it reflects the WHO definition and connotation of QOL, and common issues of cancer patients as well.

[Development of the general module of the system of quality of life instruments for cancer patients: reliability and validity analysis].

BACKGROUND & OBJECTIVE: The general module of the system of quality of life instruments for cancer patients (QLICP-GM) has been developed by us, but its psychologic properties need to be evaluated. This study was to evaluate the reliability and validity of QLICP-GM. METHODS: The QOL data of 600 patients with lung cancer, breast cancer, colorectal cancer, gastric cancer, and head and neck cancer were analyzed by paired t-tests, correlation analysis, equivalence tests, and structural equation models to evaluate QLICP-GM. RESULTS: The test-retest reliability for all domains and the overall scale was above 0.85. Internal consistency alpha values for all domains except social function domain were above 0.70. The alpha value and split-half reliability of the overall scale were 0.88 and 0.93, respectively. Correlation analyses and structural equation models displayed good construction validity of the scale. It also showed good criterion-related validity when FACT-G was used as the criterion. CONCLUSION: QLICP-GM can be used to measure QOL for cancer patients with good reliability and validity.

[Development of the general module of the system of quality of life instruments for cancer patients: responsiveness analysis].

BACKGROUND & OBJECTIVE: The general module of the system of quality of life instruments for cancer patients, QLICP-GM, has been developed and its reliability and validity has been evaluated by us. This study was to analyze its responsiveness. METHODS: The quality of life of 600 patients with 5 kinds of cancer was measured using QLICP-GM before and after treatment. Traditional significance tests with some indices, such as effect size, standardized response mean and equivalence, were applied to evaluate responsiveness. RESULTS: The quality of life score changed significantly after treatment on 3 domains: physical function, psychologic function, and general symptoms and side effects. The standardized response mean of the overall instrument ranged from 0.16 to 0.67. Equivalence test showed no equivalence on quality of life score changes of these domains and the overall instrument. CONCLUSION: QLICP-GM possesses reasonable responsiveness and can be used in clinical measurement of quality of life for cancer patients.

[Development of the system of quality of life instruments for patients with breast cancer (QLICP-BR)].

BACKGROUND & OBJECTIVE: The general module of the system of quality of life instruments for cancer patients, QLICP-GM, has been developed by us. Based on it, this study was to develop and evaluate the quality of life instrument for patients with breast cancer (QLICP-BR). METHODS: Using the structured group methods of instrument development, the instrument with Chinese cultural background was developed, and evaluated by analyzing the data from 186 breast cancer patients. RESULTS: The test-retest reliability for the overall scale and 5 domains were all above 0.75. The internal consistency alpha for each domain was higher than 0.65 except social domain (0.58). Most correlation coefficients between each item and the domain (that the item belongs to) were above 0.60. The differences between the scores before treatment and the scores after treatment for overall scale, general module, physical domain, psychologic domain, and social domain were significant. CONCLUSION: The QLICP-BR is of good validity, reliability and reasonable responsiveness, and can be used to assess quality of life for breast cancer patients.