Patients’ characteristics
Seventy-one consecutive out-patients with autoimmune liver diseases were asked to join this study. All patients agreed to participate in this study. After assessing them for the inclusion criteria, we found that no patients had previously read the descriptions about COVID-19 and its vaccines, and thus all were eligible to participate in the present study. Therefore, the required sample size we had calculated prior to the study was met. The numbers of patients with each etiology of autoimmune liver disease were: 30 with AIH, 30 with PBC, seven with overlap syndrome, and four with PSC (Table 1). According to the severity of liver disease, 86% of patients had chronic hepatitis because ten cirrhotic patients were included. Of the 71 patients, 85% were female. No patient had overt hepatic encephalopathy or jaundice. Laboratory data were summarized in Table 1.
Table 1
Etiology | | | |
| Autoimmune hepatitis | 30 | |
| Primary Biliary cholangitis | 30 | |
| Overlap syndrome | 7 | |
| Primary sclerosing cholangitis | 4 | |
Severity | Chronic hepatitis: liver cirrhosis | 61 : 10 | |
Sex | Female | 60 | |
Age | | Years | 61 | (21–81) |
Medication | Ursodeoxycholic acid (+) : (-) | 45 : 26 | |
| Prednisolone (+) : (-) | 35 : 36 | |
| Azathioprine | 14 : 54 | |
Laboratory data | | Median | Range |
| Alb | mg/dL | 4.0 | (2.1–4.6) |
| T-Bil | mg/dL | 0.8 | (0.2–2.5) |
| AST | U/L | 27 | (12–99) |
| ALT | U/L | 25 | (8-149) |
| gGT | U/L | 46 | (12–449) |
| ALP | U/L | 85 | (30–361) |
| Cre | mg/dL | 0.70 | (0.20–1.34) |
| Plt | 103/mL | 225 | (62–548) |
| PT-INR | | 1.00 | (0.91–1.12) |
Provision of information regarding COVID-19 and its vaccine supported self-decision for vaccination and reduced anxiety toward the vaccine
Before information-sharing of the description of COVID-19 and its vaccines, the number of patients who would receive vaccination was 50, while 23% (16/71) of patients could not decide on receiving the vaccine (Table 2). After information-sharing, the number of patients who could not decide on receiving the vaccine decreased to six (8%). Of the remaining 65 patients, 59 decided to receive the vaccine, while six did not. There was a significant difference in the distribution of the answer to “Will you receive the vaccine for SARS-CoV-2?” after information-sharing (p = 0.00533, Wilcoxon signed-rank test).
Table 2
Effect of information sharing to answer for questionnaire and VAS for anxiety to vaccine for SARS-CoV-2 in all subjects.
Will you receive vaccine for SARS-CoV-2? | Before | After | p value |
I will | 50 | 59 | *p = 0.00533 |
I will not | 5 | 6 |
Uncertain | 16 | 6 |
Do you feel anxiety to vaccine for SARS-CoV-2? | Before | After | p value |
Yes | 46 | 23 | **p = 0.0000108 |
No | 25 | 48 |
| Median (Range) | Median (Range) | |
VAS (mm) | 35(0-100) | 72(0-100) | *p < 0.00001 |
Asterisk indicated that data was analyzed using Wilcoxon signed-rank test. Double asterisks indicated that data was analyzed using McNemar test. |
VAS, Visual Analog Scale |
When evaluating anxiety regarding the vaccine, 65% of the patients felt anxiety toward the vaccine initially (Table 2). Because the median value was 35 mm on the VAS, which implied feeling anxiety before receiving the information, the results of the questionnaire and VAS showed similar tendencies. After information-sharing by reading the provided description, only 32% of the patients felt anxiety regarding the vaccine, thus indicating a significant decrease (p = 0.0000108, McNemar test). Similarly, a 72 mm median VAS was noted after information-sharing, indicating a significant improvement (p < 0.00001, Wilcoxon signed-rank test).
Information-sharing was more effective for patients who felt strong anxiety before receiving information
To assess the effect of information-sharing on patients’ anxiety, the correlation between the change in VAS after providing information (Delta-VAS) and either VAS before- (Pre-VAS) or after receiving the information (Post-VAS) was evaluated (Fig. 2a and 2b). Delta-VAS was calculated as subtracted values between Post-VAS and Pre-VAS responses. Delta-VAS negatively correlated with Pre-VAS (rho = − 0.4050, p = 0.00046; Spearman’s correlation), and positively correlated with Post-VAS (rho = 0.3020, p = 0.0104; Spearman’s correlation). Patients who answered with low values on Pre-VAS exhibited reduced anxiety after being provided information, while only a small part of the patients with high values on Post-VAS had answered with high values on Pre-VAS regardless of receiving the information.
Age, medication, or etiology of autoimmune liver disease were not associated with anxiety or the effect of information-sharing on anxiety
To assess the specific characteristics of patients who felt strong anxiety or required support for self-decision, we compared the correlations of VAS with age, medication, or etiology of autoimmune liver disease. We evaluated the correlation of patient age with Pre-VAS, Post-VAS, or Delta-VAS (Fig. 3a, 3b, and 3c). There was no significant correlation in any comparison. Because elderly age was known as a risk factor of unfavorable prognosis in patients with COVID-19, subjects were divided into two groups: over 65 years old and less than 65 years old. There was no significant difference regarding the Pre-VAS, Post-VAS, or Delta-VAS between these two groups (Fig. 4). Because autoimmune liver disease was treated using ursodeoxycholic acid (UDCA) and/or prednisolone (PSL), elucidating whether there was a difference in anxiety among patients treated with UDCA and PSL was desired. To assess this, subjects were divided by administration of UDCA and PSL, with Pre-VAS, Post-VAS, or Delta-VAS compared. There was no significant difference between groups with or without UDCA and with or without PSL (Fig. 5a and 5b). Because the etiology of autoimmune liver disease might affect anxiety about the SARS-CoV-2 vaccine, we compared VAS among each etiology. On comparing Pre-VAS, Post-VAS, or Delta-VAS, there were no significant differences associated with any etiology of autoimmune hepatitis (Fig. 6).
Information-sharing was effective in supporting self-decision among AIH patients and reduced anxiety in both AIH and PBC patients
Because the number of patients with both AIH and PBC satisfied our sample size requirements, the effect of information-sharing for both self-decision and anxiety was evaluated within both AIH and PBC groups. In the AIH group, providing information increased the number of patients who decided to receive the vaccine and decreased those who could not decide on receiving a vaccination (Table 3. p = 0.0105, Wilcoxon signed-rank test). Conversely, information-sharing did not significantly change the number of patients able to self-decide on vaccination in the PBC group (Table 4). On evaluating the effect of information-sharing on anxiety regarding vaccines, the number of anxious patients significantly decreased in both AIH and PBC groups after receiving the information (Tables 3 and 4; p = 0.004427 for AIH, p = 0.0159 for PBC, McNemar test). Similarly, VAS for anxiety also improved in both AIH and PBC groups after receiving the information (Tables 3 and 4. p = 0.0000717 for AIH, p = 0.000395 for PBC, Wilcoxon signed-rank test).
Table 3
Effect of information sharing to answer for questionnaire and VAS for anxiety to vaccine for SARS-CoV-2 in subjects with autoimmune hepatitis.
Will you receive vaccine for SARS-CoV-2? | Before | After | p value |
I will | 18 | 25 | *p = 0.0105 |
I will not | 2 | 2 |
Uncertain | 10 | 3 |
Do you feel anxiety to vaccine for SARS-CoV-2? | Before | After | p value |
Yes | 18 | 8 | **p = 0.004427 |
No | 12 | 22 |
| Median (Range) | Median (Range) | |
VAS (mm) | 35(0-100) | 74(20–100) | *p = 0.0000717 |
Asterisk indicated that data was analyzed using Wilcoxon signed-rank test. Double asterisks indicated that data was analyzed using McNemar test. |
VAS, Visual Analog Scale |
Table 4
Effect of information sharing to answer for questionnaire and VAS for anxiety to vaccine for SARS-CoV-2 in subjects with primary biliary cholangitis.
Will you receive vaccine for SARS-CoV-2? | Before | After | p value |
I will | 23 | 23 | *n.s. |
I will not | 3 | 4 |
Uncertain | 4 | 3 |
Do you feel anxiety to vaccine for SARS-CoV-2? | Before | After | p value |
Yes | 18 | 9 | **p = 0.0159 |
No | 12 | 21 |
| Median (Range) | Median (Range) | |
VAS (mm) | 46(0–95) | 72(0-100) | *p = 0.000395 |
Asterisk indicated that data was analyzed using Wilcoxon signed-rank test. Double asterisks indicated that data was analyzed using McNemar test. |
VAS, Visual Analog Scale |