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Research article
Validation of the Simplified Chinese Version of FACT-Hep for Patients with Hepatocellular Carcinoma Based on Combinations of Classical Test Theory and Generalizability Theory
chonghua wan
Guangdong Medical University
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Quality of life (QOL) is now concerned worldwide in cancer clinical fields and the specific instrument FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary questionnaire) is widely used in English-spoken countries. However, the specific instruments for hepatocellular carcinoma patients in China were seldom and no formal validation on the Simplified Chinese Version of the FACT-Hep was carried out. This study was aimed to validate the Chinese FACT-Hep based on Combinations of Classical Test Theory and Generalizability Theory.
Methods
The Chinese Version of FACT-Hep and the QLICP-LI were used to measure QOL three times before and after treatments from a sample of 114 in-patients of hepatocellular carcinoma. The scale were evaluated by indicators such as validity and reliability coefficients Cronbach α, Pearson r, intra-class correlation (ICC), and standardized response mean. The Generalizability Theory (G theory) was also applied to addresses the dependability of measurements and estimation of multiple sources of variance.
Results
The Internal consistency Cronbach’s α coefficients were greater than 0.70 for all domains, and test-retest reliability coefficients for all domains and the overall were greater than 0.80 (exception of emotional Well-being 0.74) with the range from 0.81 to 0.96. G-coefficients and Ф-coefficients confirmed the reliability of the scale further with exact variance components. The domains of PWB, FWB and the overall scale had significant changes after treatments with SRM ranging from 0.40 to 0.69.
Conclusions
The Chinese version of FACT-Hep has good validity, reliability, and responsiveness, and can be used to measure QOL for patients with hepatocellular carcinoma in China.
Keywords
Quality of life, Psychometric properties, Standardized response mean, Generalizability Theory, FACT-Hep, QLICP-LI
Socio-demographic And Clinical Characteristics Of Participants
The total sample included 114 inpatients with HCC. The mean age was 51 years (SD: 10; range: 31–73 years). About 80% of patients were male; the majority (96.5%) were married; 80% with Han ethnic background and more than 70% of patients had hepatitis history. The distributions of occupations were worker 14 cases (12.3%), farmer 41 (36.0%) and others 59 (51.7%). Regarding the educational level, 37 (32.5%) patients finished primary school, while 64(56.1%) completed high school of professional secondary school, and 13 (11.4%) had a college degree. Regarding the treatments, 16 cases (14.0%) had surgery; 69 (60.5%) had minimally invasive treatments; and 29 (25.5%) had other treatments.
Construct Validity
Table 1 shows the correlation between items and domains of the FACT-Hep. All correlation coefficients r were higher than 0.40 and most of them higher than 0.60 (exception of a few items of HCS such as Hep1, Hep2, Hep4 with HCS domain), which indicates strong correlations between items and their relevant domains and suggests a good item convergent validity. Additionally, there were weak correlations between items and non-relevant domains, which indicates a good discriminant validity. For example, the coefficients between domain of FWB and items within this domain (GF1-GF7) were higher than 0.70, higher than the correlation between the domain and any other items in other domains.
| Item | PWB | SWB | EWB | FWB | HCS | Total |
|---|---|---|---|---|---|---|
| GP1 | 0.66 | 0.08 | 0.34 | 0.53 | 0.48 | 0.57 |
| GP2 | 0.42 | 0.06 | 0.13 | 0.24 | 0.38 | 0.36 |
| GP3 | 0.72 | 0.15 | 0.22 | 0.39 | 0.36 | 0.49 |
| GP4 | 0.64 | 0.23 | 0.30 | 0.41 | 0.46 | 0.55 |
| GP5 | 0.62 | 0.00 | 0.16 | 0.35 | 0.36 | 0.42 |
| GP6 | 0.71 | 0.23 | 0.54 | 0.36 | 0.45 | 0.58 |
| GP7 | 0.69 | 0.19 | 0.31 | 0.43 | 0.38 | 0.53 |
| GS1 | 0.02 | 0.68 | 0.04 | 0.17 | 0.09 | 0.24 |
| GS2 | 0.05 | 0.71 | 0.01 | 0.15 | 0.05 | 0.23 |
| GS3 | 0.06 | 0.79 | 0.03 | 0.17 | 0.10 | 0.28 |
| GS4 | 0.24 | 0.72 | 0.43 | 0.50 | 0.35 | 0.56 |
| GS5 | 0.23 | 0.72 | 0.38 | 0.40 | 0.32 | 0.51 |
| GS6 | 0.24 | 0.67 | 0.15 | 0.34 | 0.30 | 0.45 |
| GS7 | 0.36 | 0.61 | 0.12 | 0.28 | 0.34 | 0.45 |
| GE1 | 0.29 | 0.19 | 0.67 | 0.40 | 0.42 | 0.50 |
| GE2 | 0.28 | 0.33 | 0.44 | 0.30 | 0.31 | 0.42 |
| GE3 | 0.40 | 0.07 | 0.42 | 0.31 | 0.27 | 0.37 |
| GE4 | 0.15 | 0.02 | 0.59 | 0.07 | 0.19 | 0.22 |
| GE5 | 0.18 | 0.10 | 0.62 | 0.17 | 0.18 | 0.23 |
| GE6 | 0.27 | 0.23 | 0.53 | 0.06 | 0.10 | 0.24 |
| GF1 | 0.56 | 0.28 | 0.25 | 0.80 | 0.49 | 0.66 |
| GF2 | 0.47 | 0.29 | 0.23 | 0.77 | 0.43 | 0.60 |
| GF3 | 0.40 | 0.27 | 0.19 | 0.79 | 0.43 | 0.59 |
| GF4 | 0.30 | 0.39 | 0.37 | 0.59 | 0.39 | 0.54 |
| GF5 | 0.44 | 0.23 | 0.35 | 0.70 | 0.57 | 0.65 |
| GF6 | 0.45 | 0.35 | 0.30 | 0.79 | 0.53 | 0.67 |
| GF7 | 0.41 | 0.20 | 0.23 | 0.70 | 0.40 | 0.54 |
| C1 | 0.27 | 0.17 | 0.26 | 0.32 | 0.57 | 0.48 |
| C2 | 0.23 | 0.17 | 0.09 | 0.25 | 0.42 | 0.36 |
| C3 | 0.24 | 0.08 | 0.30 | 0.26 | 0.47 | 0.40 |
| C4 | 0.34 | 0.13 | 0.33 | 0.40 | 0.64 | 0.55 |
| C5 | 0.22 | 0.07 | 0.15 | 0.18 | 0.42 | 0.30 |
| C6 | 0.39 | 0.17 | 0.25 | 0.47 | 0.66 | 0.58 |
| Hep1 | 0.24 | 0.00 | 0.17 | 0.09 | 0.36 | 0.26 |
| CNS7 | 0.33 | 0.15 | 0.22 | 0.27 | 0.39 | 0.39 |
| CX6 | 0.18 | 0.20 | 0.08 | 0.27 | 0.39 | 0.34 |
| HI7 | 0.51 | 0.38 | 0.45 | 0.62 | 0.58 | 0.69 |
| An7 | 0.53 | 0.28 | 0.25 | 0.68 | 0.54 | 0.64 |
| Hep2 | 0.12 | 0.10 | 0.06 | 0.08 | 0.28 | 0.21 |
| Hep3 | 0.31 | 0.10 | 0.17 | 0.22 | 0.58 | 0.44 |
| Hep4 | 0.06 | 0.01 | 0.04 | 0.00 | 0.21 | 0.10 |
| Hep5 | 0.40 | 0.17 | 0.21 | 0.36 | 0.63 | 0.54 |
| Hep6 | 0.36 | 0.08 | 0.19 | 0.16 | 0.48 | 0.38 |
| HN2 | 0.32 | 0.24 | 0.21 | 0.33 | 0.58 | 0.51 |
| Hep8 | 0.36 | 0.15 | 0.25 | 0.31 | 0.48 | 0.45 |
| PWB : Physical Well-being, SWB : Social / Family Well-being, EWB : Emotional Well-being, FWB : Functioning Well-being, HCS : Additional Concerns for HCC | ||||||
Criteria-related Validity
Table 2 presents the Pearson correlation coefficients between domains of FACT-Hep and QLICP-LI. The correlation coefficients of relevant domains in these two instruments were higher than those of non-relevant domains. For example, the correlation between EWB of FACT-Hep and PSD of QLICP-LI was 0.53, higher than other any correlations in this row. The correlations of HCS in FACT-Hep with SSD and SPD in QLICP-LI were 0.74 and 0.75 respectively. The correlation between total scores of FACT-Hep and QLICP-LI was 0.86.
| FACT-Hep | QLICP-LI | |||||
|---|---|---|---|---|---|---|
| PHD | PSD | SOD | SSD | SPD | TOT | |
| Physical Well-being(PWB) | 0.62 | 0.41 | 0.44 | 0.64 | 0.42 | 0.70 |
| Social / Family Well-being(SWB) | 0.30 | 0.21 | 0.12 | 0.26 | 0.26 | 0.33 |
| Emotional Well-being(EWB) | 0.28 | 0.53 | 0.18 | 0.30 | 0.38 | 0.48 |
| Functioning Well-being(FWB) | 0.70 | 0.44 | 0.27 | 0.61 | 0.51 | 0.73 |
| Additional Concerns(HCS) | 0.71 | 0.39 | 0.25 | 0.74 | 0.75 | 0.82 |
| Overall Scales (Total) | 0.76 | 0.50 | 0.33 | 0.74 | 0.68 | 0.86 |
Reliability From Classical Test Theory
Table 3 shows the Cronbach’s α and test-retest reliability coefficients (correlation coefficients r and ICC) of all domains. 63 inpatients completed the questionnaires that were used for test-retest reliability analysis. The paired t-tests indicated that there was no statistically significant change in domain scores between the first and the second assessments (p > 0.05), indicating equal traits and suitable conditions for test-retest reliability. Cronbach’s α coefficients of all domains were greater than 0.70. Both correlation coefficients r and ICC for all domains were larger than 0.80 exception of EWB (0.74).
| Domains(subscales/items) | Internal consistency (Cronbach’s α) | Test-retest reliability * (Correlation coefficients r ) | Test-retest reliability ( ICC and 95% CI ) |
|---|---|---|---|
| Physical Well-being(PWB) | 0.76 | 0.89 | 0.89 (0.82–0.93) |
| Social / Family Well-being(SWB) | 0.81 | 0.81 | 0.81 (0.70–0.88) |
| Emotional Well-being(EWB) | 0.72 | 0.74 | 0.73 (0.59–0.83) |
| Functioning Well-being(FWB) | 0.85 | 0.92 | 0.92 (0.86–0.95) |
| General module (FACT-G) | 0.89 | 0.93 | 0.93 (0.88–0.96) |
| Additional Concerns(HCS) | 0.81 | 0.96 | 0.96 (0.93–0.98) |
| Overall Scale (Total) | 0.92 | 0.95 | 0.95 (0.92–0.97) |
| Trial Outcome Index (TOI) | 0.90 | 0.96 | 0.96 (0.94–0.98) |
| * All correlation coefficients are statistically significant (p < 0.05). ICC: intra-class correlation, CI: confidence interval | |||
Reliability From Generalizability Theory
Table 4 showed the estimated G study results based on the p × i design, in which 114 patients filled out the 45 items of FACT-Hep. For most domains, the largest source of variance was due to item, such as 90.25% in PWB, 91.11% in SWB, 97.66% in EWB, 85.78% in HEPCS. D studies were performed to estimate the G-coefficients and Φ-coefficients for the p × i design, as well as the alternative design with different numbers of items in the five domains (see Table 5 in detail), with PWB ranging from 6 to 13, SWB and FWB from 6 to 10, EWB from 6 to 18,and HCS from 13 to 28. Generally, the G coefficients and Φ coefficients increased as the number of items in each domain increased. Under the current designs, the G and Φ coefficients were higher or close to 0.70 in four out of five domains, except for EWB. In addition, Table 5 showed the effects of the various levels of items (from 6 to 22) on reliability with G ranging from 0.517 to 0.888, and Ф ranging from 0.335 to 0.883.
| p(person) | i(item) | p* i(person*item) | ||||||
|---|---|---|---|---|---|---|---|---|
| Domain | Variance component | Percent (%) | Variance component | Percent (%) | Variance component | Percent (%) | ||
| PWB() | 2.011 | 7.83 | 23.168 | 90.25 | 0.493 | 1.92 | ||
| SWB() | 2.047 | 7.49 | 24.887 | 91.11 | 0.382 | 1.40 | ||
| EWB() | 0.997 | 1.58 | 61.626 | 97.66 | 0.482 | 0.76 | ||
| FWB | 3.508 | 47.40 | 3.357 | 45.36 | 0.536 | 7.24 | ||
| HCS() | 3.536 | 11.93 | 25.418 | 85.78 | 0.677 | 2.28 | ||
| p: person effect, i: item effect, p × i: person-by-item interaction effect | ||||||||
Due to technical limitations, Table 5 is provided in the Supplementary Files section.
Responsiveness
68 patients completed the questionnaires with regard to evaluation of responsiveness at the third assessment. As shown in Table 6, the scores of SRM regarding PWB and FWB were 0.69 and 0.40 (p < 0.05) indicate the statistically significant changes after treatments. In addition, the score changes in the general module, the overall scale and Trial Outcome Index were statistically significant with SRM being 0.56, 0.46 and 0.40, and ES being 0.50, 0.47 and 0.30 respectively.
| Domains (subscales) | Pre-treatment Mean SD | Post-treatment Mean SD | Differences Mean SD | t | p | SRM | ES | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Physical Well-being | 22.49 | 3.88 | 19.34 | 4.22 | 3.15 | 4.54 | 5.72 | 0.000 | 0.69 | 0.81 |
| Social / Family Well-being | 20.90 | 3.77 | 20.63 | 3.56 | 0.27 | 2.75 | 0.81 | 0.419 | 0.10 | 0.07 |
| Emotional Well-being | 18.68 | 2.68 | 18.25 | 2.67 | 0.43 | 2.77 | 1.27 | 0.209 | 0.15 | 0.16 |
| Functioning Well-being | 17.35 | 5.12 | 15.56 | 4.13 | 1.79 | 4.44 | 3.33 | 0.001 | 0.40 | 0.35 |
| General module | 79.42 | 11.19 | 73.78 | 11.04 | 5.64 | 10.11 | 4.60 | 0.000 | 0.56 | 0.50 |
| Additional Concerns | 58.43 | 7.57 | 57.78 | 7.09 | 0.65 | 5.54 | 0.96 | 0.339 | 0.12 | 0.09 |
| Overall Scale | 137.84 | 17.20 | 131.56 | 16.47 | 6.29 | 13.71 | 3.78 | 0.000 | 0.46 | 0.37 |
| Trial Outcome Index | 98.26 | 14.14 | 92.68 | 13.05 | 5.59 | 11.28 | 4.09 | 0.000 | 0.50 | 0.40 |
| SD: standard deviation, SRM: standardized response mean, ES: effect size | ||||||||||
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Research article
Validation of the Simplified Chinese Version of FACT-Hep for Patients with Hepatocellular Carcinoma Based on Combinations of Classical Test Theory and Generalizability Theory
chonghua wan
Guangdong Medical University
Corresponding Author
Badges
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This manuscript passed our Prescreen assessment
Complete author information
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Prescreen
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CURRENT STATUS: Posted
Version 1
Posted 23 May, 2020
No community comments so far
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PDF Downloads: ...
HTML Views: ...
Subject Areas
Gastroenterology & Hepatology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Quality of life (QOL) is now concerned worldwide in cancer clinical fields and the specific instrument FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary questionnaire) is widely used in English-spoken countries. However, the specific instruments for hepatocellular carcinoma patients in China were seldom and no formal validation on the Simplified Chinese Version of the FACT-Hep was carried out. This study was aimed to validate the Chinese FACT-Hep based on Combinations of Classical Test Theory and Generalizability Theory.
Methods
The Chinese Version of FACT-Hep and the QLICP-LI were used to measure QOL three times before and after treatments from a sample of 114 in-patients of hepatocellular carcinoma. The scale were evaluated by indicators such as validity and reliability coefficients Cronbach α, Pearson r, intra-class correlation (ICC), and standardized response mean. The Generalizability Theory (G theory) was also applied to addresses the dependability of measurements and estimation of multiple sources of variance.
Results
The Internal consistency Cronbach’s α coefficients were greater than 0.70 for all domains, and test-retest reliability coefficients for all domains and the overall were greater than 0.80 (exception of emotional Well-being 0.74) with the range from 0.81 to 0.96. G-coefficients and Ф-coefficients confirmed the reliability of the scale further with exact variance components. The domains of PWB, FWB and the overall scale had significant changes after treatments with SRM ranging from 0.40 to 0.69.
Conclusions
The Chinese version of FACT-Hep has good validity, reliability, and responsiveness, and can be used to measure QOL for patients with hepatocellular carcinoma in China.
Socio-demographic And Clinical Characteristics Of Participants
The total sample included 114 inpatients with HCC. The mean age was 51 years (SD: 10; range: 31–73 years). About 80% of patients were male; the majority (96.5%) were married; 80% with Han ethnic background and more than 70% of patients had hepatitis history. The distributions of occupations were worker 14 cases (12.3%), farmer 41 (36.0%) and others 59 (51.7%). Regarding the educational level, 37 (32.5%) patients finished primary school, while 64(56.1%) completed high school of professional secondary school, and 13 (11.4%) had a college degree. Regarding the treatments, 16 cases (14.0%) had surgery; 69 (60.5%) had minimally invasive treatments; and 29 (25.5%) had other treatments.
Construct Validity
Table 1 shows the correlation between items and domains of the FACT-Hep. All correlation coefficients r were higher than 0.40 and most of them higher than 0.60 (exception of a few items of HCS such as Hep1, Hep2, Hep4 with HCS domain), which indicates strong correlations between items and their relevant domains and suggests a good item convergent validity. Additionally, there were weak correlations between items and non-relevant domains, which indicates a good discriminant validity. For example, the coefficients between domain of FWB and items within this domain (GF1-GF7) were higher than 0.70, higher than the correlation between the domain and any other items in other domains.
| Item | PWB | SWB | EWB | FWB | HCS | Total |
|---|---|---|---|---|---|---|
| GP1 | 0.66 | 0.08 | 0.34 | 0.53 | 0.48 | 0.57 |
| GP2 | 0.42 | 0.06 | 0.13 | 0.24 | 0.38 | 0.36 |
| GP3 | 0.72 | 0.15 | 0.22 | 0.39 | 0.36 | 0.49 |
| GP4 | 0.64 | 0.23 | 0.30 | 0.41 | 0.46 | 0.55 |
| GP5 | 0.62 | 0.00 | 0.16 | 0.35 | 0.36 | 0.42 |
| GP6 | 0.71 | 0.23 | 0.54 | 0.36 | 0.45 | 0.58 |
| GP7 | 0.69 | 0.19 | 0.31 | 0.43 | 0.38 | 0.53 |
| GS1 | 0.02 | 0.68 | 0.04 | 0.17 | 0.09 | 0.24 |
| GS2 | 0.05 | 0.71 | 0.01 | 0.15 | 0.05 | 0.23 |
| GS3 | 0.06 | 0.79 | 0.03 | 0.17 | 0.10 | 0.28 |
| GS4 | 0.24 | 0.72 | 0.43 | 0.50 | 0.35 | 0.56 |
| GS5 | 0.23 | 0.72 | 0.38 | 0.40 | 0.32 | 0.51 |
| GS6 | 0.24 | 0.67 | 0.15 | 0.34 | 0.30 | 0.45 |
| GS7 | 0.36 | 0.61 | 0.12 | 0.28 | 0.34 | 0.45 |
| GE1 | 0.29 | 0.19 | 0.67 | 0.40 | 0.42 | 0.50 |
| GE2 | 0.28 | 0.33 | 0.44 | 0.30 | 0.31 | 0.42 |
| GE3 | 0.40 | 0.07 | 0.42 | 0.31 | 0.27 | 0.37 |
| GE4 | 0.15 | 0.02 | 0.59 | 0.07 | 0.19 | 0.22 |
| GE5 | 0.18 | 0.10 | 0.62 | 0.17 | 0.18 | 0.23 |
| GE6 | 0.27 | 0.23 | 0.53 | 0.06 | 0.10 | 0.24 |
| GF1 | 0.56 | 0.28 | 0.25 | 0.80 | 0.49 | 0.66 |
| GF2 | 0.47 | 0.29 | 0.23 | 0.77 | 0.43 | 0.60 |
| GF3 | 0.40 | 0.27 | 0.19 | 0.79 | 0.43 | 0.59 |
| GF4 | 0.30 | 0.39 | 0.37 | 0.59 | 0.39 | 0.54 |
| GF5 | 0.44 | 0.23 | 0.35 | 0.70 | 0.57 | 0.65 |
| GF6 | 0.45 | 0.35 | 0.30 | 0.79 | 0.53 | 0.67 |
| GF7 | 0.41 | 0.20 | 0.23 | 0.70 | 0.40 | 0.54 |
| C1 | 0.27 | 0.17 | 0.26 | 0.32 | 0.57 | 0.48 |
| C2 | 0.23 | 0.17 | 0.09 | 0.25 | 0.42 | 0.36 |
| C3 | 0.24 | 0.08 | 0.30 | 0.26 | 0.47 | 0.40 |
| C4 | 0.34 | 0.13 | 0.33 | 0.40 | 0.64 | 0.55 |
| C5 | 0.22 | 0.07 | 0.15 | 0.18 | 0.42 | 0.30 |
| C6 | 0.39 | 0.17 | 0.25 | 0.47 | 0.66 | 0.58 |
| Hep1 | 0.24 | 0.00 | 0.17 | 0.09 | 0.36 | 0.26 |
| CNS7 | 0.33 | 0.15 | 0.22 | 0.27 | 0.39 | 0.39 |
| CX6 | 0.18 | 0.20 | 0.08 | 0.27 | 0.39 | 0.34 |
| HI7 | 0.51 | 0.38 | 0.45 | 0.62 | 0.58 | 0.69 |
| An7 | 0.53 | 0.28 | 0.25 | 0.68 | 0.54 | 0.64 |
| Hep2 | 0.12 | 0.10 | 0.06 | 0.08 | 0.28 | 0.21 |
| Hep3 | 0.31 | 0.10 | 0.17 | 0.22 | 0.58 | 0.44 |
| Hep4 | 0.06 | 0.01 | 0.04 | 0.00 | 0.21 | 0.10 |
| Hep5 | 0.40 | 0.17 | 0.21 | 0.36 | 0.63 | 0.54 |
| Hep6 | 0.36 | 0.08 | 0.19 | 0.16 | 0.48 | 0.38 |
| HN2 | 0.32 | 0.24 | 0.21 | 0.33 | 0.58 | 0.51 |
| Hep8 | 0.36 | 0.15 | 0.25 | 0.31 | 0.48 | 0.45 |
| PWB : Physical Well-being, SWB : Social / Family Well-being, EWB : Emotional Well-being, FWB : Functioning Well-being, HCS : Additional Concerns for HCC | ||||||
Criteria-related Validity
Table 2 presents the Pearson correlation coefficients between domains of FACT-Hep and QLICP-LI. The correlation coefficients of relevant domains in these two instruments were higher than those of non-relevant domains. For example, the correlation between EWB of FACT-Hep and PSD of QLICP-LI was 0.53, higher than other any correlations in this row. The correlations of HCS in FACT-Hep with SSD and SPD in QLICP-LI were 0.74 and 0.75 respectively. The correlation between total scores of FACT-Hep and QLICP-LI was 0.86.
| FACT-Hep | QLICP-LI | |||||
|---|---|---|---|---|---|---|
| PHD | PSD | SOD | SSD | SPD | TOT | |
| Physical Well-being(PWB) | 0.62 | 0.41 | 0.44 | 0.64 | 0.42 | 0.70 |
| Social / Family Well-being(SWB) | 0.30 | 0.21 | 0.12 | 0.26 | 0.26 | 0.33 |
| Emotional Well-being(EWB) | 0.28 | 0.53 | 0.18 | 0.30 | 0.38 | 0.48 |
| Functioning Well-being(FWB) | 0.70 | 0.44 | 0.27 | 0.61 | 0.51 | 0.73 |
| Additional Concerns(HCS) | 0.71 | 0.39 | 0.25 | 0.74 | 0.75 | 0.82 |
| Overall Scales (Total) | 0.76 | 0.50 | 0.33 | 0.74 | 0.68 | 0.86 |
Reliability From Classical Test Theory
Table 3 shows the Cronbach’s α and test-retest reliability coefficients (correlation coefficients r and ICC) of all domains. 63 inpatients completed the questionnaires that were used for test-retest reliability analysis. The paired t-tests indicated that there was no statistically significant change in domain scores between the first and the second assessments (p > 0.05), indicating equal traits and suitable conditions for test-retest reliability. Cronbach’s α coefficients of all domains were greater than 0.70. Both correlation coefficients r and ICC for all domains were larger than 0.80 exception of EWB (0.74).
| Domains(subscales/items) | Internal consistency (Cronbach’s α) | Test-retest reliability * (Correlation coefficients r ) | Test-retest reliability ( ICC and 95% CI ) |
|---|---|---|---|
| Physical Well-being(PWB) | 0.76 | 0.89 | 0.89 (0.82–0.93) |
| Social / Family Well-being(SWB) | 0.81 | 0.81 | 0.81 (0.70–0.88) |
| Emotional Well-being(EWB) | 0.72 | 0.74 | 0.73 (0.59–0.83) |
| Functioning Well-being(FWB) | 0.85 | 0.92 | 0.92 (0.86–0.95) |
| General module (FACT-G) | 0.89 | 0.93 | 0.93 (0.88–0.96) |
| Additional Concerns(HCS) | 0.81 | 0.96 | 0.96 (0.93–0.98) |
| Overall Scale (Total) | 0.92 | 0.95 | 0.95 (0.92–0.97) |
| Trial Outcome Index (TOI) | 0.90 | 0.96 | 0.96 (0.94–0.98) |
| * All correlation coefficients are statistically significant (p < 0.05). ICC: intra-class correlation, CI: confidence interval | |||
Reliability From Generalizability Theory
Table 4 showed the estimated G study results based on the p × i design, in which 114 patients filled out the 45 items of FACT-Hep. For most domains, the largest source of variance was due to item, such as 90.25% in PWB, 91.11% in SWB, 97.66% in EWB, 85.78% in HEPCS. D studies were performed to estimate the G-coefficients and Φ-coefficients for the p × i design, as well as the alternative design with different numbers of items in the five domains (see Table 5 in detail), with PWB ranging from 6 to 13, SWB and FWB from 6 to 10, EWB from 6 to 18,and HCS from 13 to 28. Generally, the G coefficients and Φ coefficients increased as the number of items in each domain increased. Under the current designs, the G and Φ coefficients were higher or close to 0.70 in four out of five domains, except for EWB. In addition, Table 5 showed the effects of the various levels of items (from 6 to 22) on reliability with G ranging from 0.517 to 0.888, and Ф ranging from 0.335 to 0.883.
| p(person) | i(item) | p* i(person*item) | ||||||
|---|---|---|---|---|---|---|---|---|
| Domain | Variance component | Percent (%) | Variance component | Percent (%) | Variance component | Percent (%) | ||
| PWB() | 2.011 | 7.83 | 23.168 | 90.25 | 0.493 | 1.92 | ||
| SWB() | 2.047 | 7.49 | 24.887 | 91.11 | 0.382 | 1.40 | ||
| EWB() | 0.997 | 1.58 | 61.626 | 97.66 | 0.482 | 0.76 | ||
| FWB | 3.508 | 47.40 | 3.357 | 45.36 | 0.536 | 7.24 | ||
| HCS() | 3.536 | 11.93 | 25.418 | 85.78 | 0.677 | 2.28 | ||
| p: person effect, i: item effect, p × i: person-by-item interaction effect | ||||||||
Due to technical limitations, Table 5 is provided in the Supplementary Files section.
Responsiveness
68 patients completed the questionnaires with regard to evaluation of responsiveness at the third assessment. As shown in Table 6, the scores of SRM regarding PWB and FWB were 0.69 and 0.40 (p < 0.05) indicate the statistically significant changes after treatments. In addition, the score changes in the general module, the overall scale and Trial Outcome Index were statistically significant with SRM being 0.56, 0.46 and 0.40, and ES being 0.50, 0.47 and 0.30 respectively.
| Domains (subscales) | Pre-treatment Mean SD | Post-treatment Mean SD | Differences Mean SD | t | p | SRM | ES | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Physical Well-being | 22.49 | 3.88 | 19.34 | 4.22 | 3.15 | 4.54 | 5.72 | 0.000 | 0.69 | 0.81 |
| Social / Family Well-being | 20.90 | 3.77 | 20.63 | 3.56 | 0.27 | 2.75 | 0.81 | 0.419 | 0.10 | 0.07 |
| Emotional Well-being | 18.68 | 2.68 | 18.25 | 2.67 | 0.43 | 2.77 | 1.27 | 0.209 | 0.15 | 0.16 |
| Functioning Well-being | 17.35 | 5.12 | 15.56 | 4.13 | 1.79 | 4.44 | 3.33 | 0.001 | 0.40 | 0.35 |
| General module | 79.42 | 11.19 | 73.78 | 11.04 | 5.64 | 10.11 | 4.60 | 0.000 | 0.56 | 0.50 |
| Additional Concerns | 58.43 | 7.57 | 57.78 | 7.09 | 0.65 | 5.54 | 0.96 | 0.339 | 0.12 | 0.09 |
| Overall Scale | 137.84 | 17.20 | 131.56 | 16.47 | 6.29 | 13.71 | 3.78 | 0.000 | 0.46 | 0.37 |
| Trial Outcome Index | 98.26 | 14.14 | 92.68 | 13.05 | 5.59 | 11.28 | 4.09 | 0.000 | 0.50 | 0.40 |
| SD: standard deviation, SRM: standardized response mean, ES: effect size | ||||||||||