よむ、つかう、まなぶ。
慶應義塾大学 岸本特任教授 御提出資料 (5 ページ)
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| 出典情報 | 規制改革推進会議 健康・医療・介護ワーキング・グループ（第4回 12／18）《内閣府》 |
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Psychiatry and
Clinical Neurosciences
RCT of 24-week two-way video vs face-to-face treatment
Table 1. Baseline demographic and clinical characteristics
Age (years)
Sex (female), n (%)
Psychiatric history
Duration since the first episode (months)
Duration since current episode (months)
Duration of total treatment (months)
Duration of treatment by a current physician
Diagnosis, n (%)
Depressive disorder
Anxiety disorder
OCD and related disorders
Measures
HAMD-17 (depressive disorders only)
HAMA (anxiety disorders only)
YBOCS (OCD and related disorders only)
Two-way video
(n = 98)
Face-to-face
(n = 90)
P-value
39.7 11.9
48 (49.0)
40.7 11.9
46 (51.1)
0.55
0.88
105.1 90.3
82.7 78.5
78.5 73.6
38.0 45.5
105.7 99.5
72.2 83.2
79.9 78.9
35.4 37.5
0.97
0.38
0.90
0.66
50 (51.0)
30 (30.6)
18 (18.4)
42 (46.7)
31 (34.4)
17 (18.9)
8.3 1.5
10.2 1.9
14.1 1.8
6.1 1.5
11.5 2.1
15.6 2.1
0.08
0.42
0.51
Data are mean SD unless otherwise indicated.
EQ-5D, EuroQol 5 Dimension; HAMA, Hamilton Anxiety Rating Scale; HAMD, Hamilton Depression Rating Scale; OCD, obsessive-compulsive
disorder; SF-36 MCS, 36-Item Short-Form Health Survey Mental Component Summary; YBOCS, Yale-Brown Obsessive Compulsive Scale.
Table 2. SF-36 MCS
Weeks
Noninferiority tests (margin: 5)
SF-36 MCS (FAS)
24
MMRM
SF-36 MCS (FAS)
0 (baseline)
12
24
Noninferiority tests (margin: 5)
SF-36 MCS (PPS)
24
MMRM
SF-36 MCS (PPS)
0 (baseline)
12
24
Two-way video
Face-to-face
Difference in mean (95% CI)
P-value
48.50 0.57 (n = 96)
46.68 10.58 (n = 86)
1.82 ( 1.12 to 4.77)
<0.0001
47.96 1.88 (n = 98)
47.55 1.88 (n = 98)
48.97 1.90 (n = 96)
45.44 1.92 (n = 90)
46.36 1.92 (n = 89)
47.50 1.95 (n = 86)
2.52 ( 0.13 to 5.17)
1.19 ( 1.47 to 3.84)
1.48 ( 1.33 to 4.29)
0.06
0.38
0.30
48.50 9.57 (n = 96)
46.60 10.62 (n = 85)
1.90 ( 1.06 to 4.86)
<0.0001
48.26 1.88 (n = 96)
47.89 1.88 (n = 96)
49.30 1.91 (n = 96)
46.13 1.92 (n = 85)
46.71 1.92 (n = 85)
47.75 1.95 (n = 85)
2.13 ( 0.05 to 4.83)
1.18 ( 1.50 to 3.86)
1.55 ( 1.27 to 4.37)
0.12
0.39
0.28
Data are mean SD.
CI, confidence interval; FAS, full analysis set; MMRM, mixed-effect model for repeated measure; PPS, per protocol set; SF-36 MCS, 36-Item
Short-Form Health Survey Mental Component Summary.
The eight SF-36 subscale scores at weeks 12 and 24 also did not differ significantly between the two groups. All-cause discontinuation
was found in one case (1%) in the two-way video group and one case
(1.1%) in the face-to-face group, with no statistically significant difference (P = 0.95). There was no significant difference in the WAI or
CSQ scores (P = 0.25) between the two groups at weeks 12 and 24.
There were four cases of adverse events in the two-way video group
and five in the face-to-face group, with no significant difference
between the groups with respect to the risk of adverse events
(P = 0.7). Most of the adverse events consisted of physical illnesses
such as cholecystitis, posterior longitudinal ligament ossification, and
abdominal pain, which were not related to the intervention.
Regarding the time required for hospital visits, the two-way video
group spent less time than the face-to-face group (42.9 40.8 min in
the two-way video group and 79.2 61.6 min in the face-to-face
Psychiatry and Clinical Neurosciences
group, respectively; P < 0.001). Regarding the costs incurred for hospital visits (including communication costs for two-way video), nonparametric tests were used because there was a large variation in costs and
high outliers due to the variety of forms of hospital visits and the readiness of the communication environment. As a result, the two-way video
group paid less than the face-to-face group (median, 168.9 [interquartile range, 0–793.3] Japanese yen in the two-way video group and
500.0 [interquartile range, 140.0–1266.7] yen for the face-to-face
group, respectively, P = 0.01) (Table 4). The number of work days
missed for treatment sessions averaged 1.5 2.5 in the two-way video
group and 2.6 7.1 in the face-to-face group, with no significant difference between the two groups (P = 0.15). The EQ-5D scores did not
differ significantly between the two groups (P = 0.97).
There were no significant differences in disease severity between
the two groups at 12 and 24 weeks as assessed based on the HAMD,
5
14401819, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/pcn.13618 by Cochrane Japan, Wiley Online Library on [16/12/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
PCN
Clinical Neurosciences
RCT of 24-week two-way video vs face-to-face treatment
Table 1. Baseline demographic and clinical characteristics
Age (years)
Sex (female), n (%)
Psychiatric history
Duration since the first episode (months)
Duration since current episode (months)
Duration of total treatment (months)
Duration of treatment by a current physician
Diagnosis, n (%)
Depressive disorder
Anxiety disorder
OCD and related disorders
Measures
HAMD-17 (depressive disorders only)
HAMA (anxiety disorders only)
YBOCS (OCD and related disorders only)
Two-way video
(n = 98)
Face-to-face
(n = 90)
P-value
39.7 11.9
48 (49.0)
40.7 11.9
46 (51.1)
0.55
0.88
105.1 90.3
82.7 78.5
78.5 73.6
38.0 45.5
105.7 99.5
72.2 83.2
79.9 78.9
35.4 37.5
0.97
0.38
0.90
0.66
50 (51.0)
30 (30.6)
18 (18.4)
42 (46.7)
31 (34.4)
17 (18.9)
8.3 1.5
10.2 1.9
14.1 1.8
6.1 1.5
11.5 2.1
15.6 2.1
0.08
0.42
0.51
Data are mean SD unless otherwise indicated.
EQ-5D, EuroQol 5 Dimension; HAMA, Hamilton Anxiety Rating Scale; HAMD, Hamilton Depression Rating Scale; OCD, obsessive-compulsive
disorder; SF-36 MCS, 36-Item Short-Form Health Survey Mental Component Summary; YBOCS, Yale-Brown Obsessive Compulsive Scale.
Table 2. SF-36 MCS
Weeks
Noninferiority tests (margin: 5)
SF-36 MCS (FAS)
24
MMRM
SF-36 MCS (FAS)
0 (baseline)
12
24
Noninferiority tests (margin: 5)
SF-36 MCS (PPS)
24
MMRM
SF-36 MCS (PPS)
0 (baseline)
12
24
Two-way video
Face-to-face
Difference in mean (95% CI)
P-value
48.50 0.57 (n = 96)
46.68 10.58 (n = 86)
1.82 ( 1.12 to 4.77)
<0.0001
47.96 1.88 (n = 98)
47.55 1.88 (n = 98)
48.97 1.90 (n = 96)
45.44 1.92 (n = 90)
46.36 1.92 (n = 89)
47.50 1.95 (n = 86)
2.52 ( 0.13 to 5.17)
1.19 ( 1.47 to 3.84)
1.48 ( 1.33 to 4.29)
0.06
0.38
0.30
48.50 9.57 (n = 96)
46.60 10.62 (n = 85)
1.90 ( 1.06 to 4.86)
<0.0001
48.26 1.88 (n = 96)
47.89 1.88 (n = 96)
49.30 1.91 (n = 96)
46.13 1.92 (n = 85)
46.71 1.92 (n = 85)
47.75 1.95 (n = 85)
2.13 ( 0.05 to 4.83)
1.18 ( 1.50 to 3.86)
1.55 ( 1.27 to 4.37)
0.12
0.39
0.28
Data are mean SD.
CI, confidence interval; FAS, full analysis set; MMRM, mixed-effect model for repeated measure; PPS, per protocol set; SF-36 MCS, 36-Item
Short-Form Health Survey Mental Component Summary.
The eight SF-36 subscale scores at weeks 12 and 24 also did not differ significantly between the two groups. All-cause discontinuation
was found in one case (1%) in the two-way video group and one case
(1.1%) in the face-to-face group, with no statistically significant difference (P = 0.95). There was no significant difference in the WAI or
CSQ scores (P = 0.25) between the two groups at weeks 12 and 24.
There were four cases of adverse events in the two-way video group
and five in the face-to-face group, with no significant difference
between the groups with respect to the risk of adverse events
(P = 0.7). Most of the adverse events consisted of physical illnesses
such as cholecystitis, posterior longitudinal ligament ossification, and
abdominal pain, which were not related to the intervention.
Regarding the time required for hospital visits, the two-way video
group spent less time than the face-to-face group (42.9 40.8 min in
the two-way video group and 79.2 61.6 min in the face-to-face
Psychiatry and Clinical Neurosciences
group, respectively; P < 0.001). Regarding the costs incurred for hospital visits (including communication costs for two-way video), nonparametric tests were used because there was a large variation in costs and
high outliers due to the variety of forms of hospital visits and the readiness of the communication environment. As a result, the two-way video
group paid less than the face-to-face group (median, 168.9 [interquartile range, 0–793.3] Japanese yen in the two-way video group and
500.0 [interquartile range, 140.0–1266.7] yen for the face-to-face
group, respectively, P = 0.01) (Table 4). The number of work days
missed for treatment sessions averaged 1.5 2.5 in the two-way video
group and 2.6 7.1 in the face-to-face group, with no significant difference between the two groups (P = 0.15). The EQ-5D scores did not
differ significantly between the two groups (P = 0.97).
There were no significant differences in disease severity between
the two groups at 12 and 24 weeks as assessed based on the HAMD,
5
14401819, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/pcn.13618 by Cochrane Japan, Wiley Online Library on [16/12/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
PCN