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 (6 ページ)
出典
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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
Table 3. Secondary outcomes
SF-36 PCS
WAI
CSQ
EQ-5D
Degree of anxiety about
COVID-19 (VAS)
HAMD-17 (depressive disorders
only)
HAMA (anxiety disorders only)
YBOCS (OCD and related
disorders only)
Weeks
Two-way video
Face-to-face
Difference in mean (95% CI)
P-value
0 (baseline)
12
24
12
24
12
24
0 (baseline)
12
24
0 (baseline)
48.19 1.72 (n = 98)
47.92 1.71 (n = 98)
49.48 1.75 (n = 96)
71.7 2.8 (n = 98)
71.6 2.8 (n = 96)
26.9 0.9 (n = 98)
27.3 0.9 (n = 96)
0.811 0.029 (n = 98)
0.807 0.030 (n = 98)
0.828 0.029 (n = 96)
46.3 5.3 (n = 98)
48.35 1.77 (n = 90)
47.06 1.75 (n = 89)
47.49 1.79 (n = 86)
68.1 2.9 (n = 87)
69.5 2.9 (n = 85)
26.2 0.9 (n = 87)
26.5 1.0 (n = 85)
0.823 0.030 (n = 89)
0.822 0.031 (n = 88)
0.829 0.030 (n = 86)
49.0 5.5 (n = 89)
0.17 ( 2.63 to 2.30)
0.86 ( 1.51 to 3.24)
2.00 ( 0.60 to 4.60)
3.6 ( 0.1 to 7.4)
2.1 ( 1.9 to 6.0)
0.7 ( 0.5 to 2.0)
0.8 ( 0.6 to 2.1)
0.011 ( 0.052 to 0.029)
0.014 ( 0.062 to 0.033)
0.001 ( 0.0045 to 0.043)
2.7 ( 10.7 to 5.2)
0.90
0.48
0.13
0.06
0.31
0.24
0.25
0.58
0.55
0.97
0.50
12
24
0 (baseline)
44.3 5.4 (n = 98)
43.2 5.3 (n = 96)
8.3 1.5 (n = 50)
47.0 5.5 (n = 87)
44.2 5.4 (n = 86)
6.1 1.5 (n = 42)
2.8 ( 11.0 to 5.4)
0.9 ( 8.7 to 6.9)
2.2 ( 0.3 to 4.6)
0.50
0.82
0.09
12
24
0 (baseline)
12
24
0 (baseline)
8.8 1.5 (n = 50)
7.9 1.6 (n = 48)
10.2 1.9 (n = 30)
9.7 2.0 (n = 29)
8.7 1.8 (n = 29)
14.1 1.8 (n = 18)
6.0 1.6 (n = 41)
5.9 1.7 (n = 39)
11.5 2.1 (n = 31)
12.2 2.1 (n = 31)
9.0 1.9 (n = 30)
15.6 2.1 (n = 17)
2.8 (0.2 to 5.4)
2.0 ( 1.0 to 5.0)
1.3 ( 4.7 to 2.0)
2.5 ( 6.1 to 1.0)
0.3 ( 2.8 to 2.2)
1.5 ( 6.2 to 3.2)
0.03
0.18
0.42
0.15
0.81
0.52
12
24
14.0 1.8 (n = 18)
12.9 1.8 (n = 18)
15.0 2.1 (n = 16)
14.0 2.1 (n = 16)
1.0 ( 5.8 to 3.8)
1.1 ( 5.7 to 3.5)
0.67
0.62
Data are mean SD.
CI, confidence interval; CSQ, Client Satisfaction Questionnaire; EQ-5D, EuroQol 5 Dimension; HAMA, Hamilton Anxiety Rating Scale; HAMD,
Hamilton Depression Rating Scale; OCD, obsessive-compulsive disorder; SF-36 PCS, 36-Item Short-Form Health Survey Physical Component
Summary; VAS, visual analog scale; WAI, Working Alliance Inventory; YBOCS, Yale-Brown Obsessive Compulsive Scale.
the changes from the respective baseline values in the two groups, are
presented in the Supplementary Tables S2 and S3.
Table 4. Hospital visit costs and time
Two-way video
(n = 98)
Face-to-face
(n = 90)
Number of hospital visit during the study period
Mean SD
6.3 2.8
5.7 2.5
95% CI
5.7–6.8
2.1–6.2
Time required per hospital visit (minutes)
Mean SD
42.9 40.8
79.2 61.6
95% CI
34.7–51.1
66.3–92.1
Cost per hospital visit (Japanese yen)
Median
168.9
500.0
IQR
0.0–793.3
140–1266.7
Number of work days missed for hospital visits
Mean SD
1.5 2.5
2.6 7.1
95% CI
1.1–2.0
1.2–4.1
P-value
0.12
<0.0001
0.0104
0.15
CI, confidence interval; IQR, interquartile range.
HAMA, and YBOCS scores, except that the HAMD score at 12 weeks
in the two-way video group was higher than that in the face-to-face
group (P = 0.03). Data regarding other secondary outcomes, including
6
Discussion
Here, we report the results of a large-scale, long-term study comparing two-way video and face-to-face treatment in the real-world clinical setting. The most important feature of this pragmatic trial is that it
adapted relatively broad inclusion criteria, namely depressive disorder,
anxiety disorders, OCD and related disorders, and examined the effect
of long-term treatment over 6 months. The treatment provided was
the same as that in general outpatient care with no restrictions on the
number of visits or treatment content. In other words, the psychiatrists
in the study provided the best insurance-covered treatment they considered appropriate in a two-way video or face-to-face setting. In
addition, the study was validated in a modern telemedicine setting,
where patients easily accessed and received treatment from a psychiatrist at home or in the office using smartphones, tablets, or personal
computers. Most of the telemedicine RCTs to date have been relatively short-term trials for a single disorder, often with some form of
specific treatment. To our knowledge, there are very few pragmatic
RCTs validating two-way video treatment that incorporate multiple
psychiatric disorders.9 In addition, each trial design has limitations,
such as a limited follow-up period of less than 6 months11 or, in the
case of long-term follow-up studies, the number of participants is limited to a few dozen12 to 140.10 Through the COVID-19 pandemic,
two-way video appointments became established as a common
method of psychiatric care delivery. Patients can now easily see their
Psychiatry and Clinical Neurosciences
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
RCT of 24-week two-way video vs face-to-face treatment
Clinical Neurosciences
Table 3. Secondary outcomes
SF-36 PCS
WAI
CSQ
EQ-5D
Degree of anxiety about
COVID-19 (VAS)
HAMD-17 (depressive disorders
only)
HAMA (anxiety disorders only)
YBOCS (OCD and related
disorders only)
Weeks
Two-way video
Face-to-face
Difference in mean (95% CI)
P-value
0 (baseline)
12
24
12
24
12
24
0 (baseline)
12
24
0 (baseline)
48.19 1.72 (n = 98)
47.92 1.71 (n = 98)
49.48 1.75 (n = 96)
71.7 2.8 (n = 98)
71.6 2.8 (n = 96)
26.9 0.9 (n = 98)
27.3 0.9 (n = 96)
0.811 0.029 (n = 98)
0.807 0.030 (n = 98)
0.828 0.029 (n = 96)
46.3 5.3 (n = 98)
48.35 1.77 (n = 90)
47.06 1.75 (n = 89)
47.49 1.79 (n = 86)
68.1 2.9 (n = 87)
69.5 2.9 (n = 85)
26.2 0.9 (n = 87)
26.5 1.0 (n = 85)
0.823 0.030 (n = 89)
0.822 0.031 (n = 88)
0.829 0.030 (n = 86)
49.0 5.5 (n = 89)
0.17 ( 2.63 to 2.30)
0.86 ( 1.51 to 3.24)
2.00 ( 0.60 to 4.60)
3.6 ( 0.1 to 7.4)
2.1 ( 1.9 to 6.0)
0.7 ( 0.5 to 2.0)
0.8 ( 0.6 to 2.1)
0.011 ( 0.052 to 0.029)
0.014 ( 0.062 to 0.033)
0.001 ( 0.0045 to 0.043)
2.7 ( 10.7 to 5.2)
0.90
0.48
0.13
0.06
0.31
0.24
0.25
0.58
0.55
0.97
0.50
12
24
0 (baseline)
44.3 5.4 (n = 98)
43.2 5.3 (n = 96)
8.3 1.5 (n = 50)
47.0 5.5 (n = 87)
44.2 5.4 (n = 86)
6.1 1.5 (n = 42)
2.8 ( 11.0 to 5.4)
0.9 ( 8.7 to 6.9)
2.2 ( 0.3 to 4.6)
0.50
0.82
0.09
12
24
0 (baseline)
12
24
0 (baseline)
8.8 1.5 (n = 50)
7.9 1.6 (n = 48)
10.2 1.9 (n = 30)
9.7 2.0 (n = 29)
8.7 1.8 (n = 29)
14.1 1.8 (n = 18)
6.0 1.6 (n = 41)
5.9 1.7 (n = 39)
11.5 2.1 (n = 31)
12.2 2.1 (n = 31)
9.0 1.9 (n = 30)
15.6 2.1 (n = 17)
2.8 (0.2 to 5.4)
2.0 ( 1.0 to 5.0)
1.3 ( 4.7 to 2.0)
2.5 ( 6.1 to 1.0)
0.3 ( 2.8 to 2.2)
1.5 ( 6.2 to 3.2)
0.03
0.18
0.42
0.15
0.81
0.52
12
24
14.0 1.8 (n = 18)
12.9 1.8 (n = 18)
15.0 2.1 (n = 16)
14.0 2.1 (n = 16)
1.0 ( 5.8 to 3.8)
1.1 ( 5.7 to 3.5)
0.67
0.62
Data are mean SD.
CI, confidence interval; CSQ, Client Satisfaction Questionnaire; EQ-5D, EuroQol 5 Dimension; HAMA, Hamilton Anxiety Rating Scale; HAMD,
Hamilton Depression Rating Scale; OCD, obsessive-compulsive disorder; SF-36 PCS, 36-Item Short-Form Health Survey Physical Component
Summary; VAS, visual analog scale; WAI, Working Alliance Inventory; YBOCS, Yale-Brown Obsessive Compulsive Scale.
the changes from the respective baseline values in the two groups, are
presented in the Supplementary Tables S2 and S3.
Table 4. Hospital visit costs and time
Two-way video
(n = 98)
Face-to-face
(n = 90)
Number of hospital visit during the study period
Mean SD
6.3 2.8
5.7 2.5
95% CI
5.7–6.8
2.1–6.2
Time required per hospital visit (minutes)
Mean SD
42.9 40.8
79.2 61.6
95% CI
34.7–51.1
66.3–92.1
Cost per hospital visit (Japanese yen)
Median
168.9
500.0
IQR
0.0–793.3
140–1266.7
Number of work days missed for hospital visits
Mean SD
1.5 2.5
2.6 7.1
95% CI
1.1–2.0
1.2–4.1
P-value
0.12
<0.0001
0.0104
0.15
CI, confidence interval; IQR, interquartile range.
HAMA, and YBOCS scores, except that the HAMD score at 12 weeks
in the two-way video group was higher than that in the face-to-face
group (P = 0.03). Data regarding other secondary outcomes, including
6
Discussion
Here, we report the results of a large-scale, long-term study comparing two-way video and face-to-face treatment in the real-world clinical setting. The most important feature of this pragmatic trial is that it
adapted relatively broad inclusion criteria, namely depressive disorder,
anxiety disorders, OCD and related disorders, and examined the effect
of long-term treatment over 6 months. The treatment provided was
the same as that in general outpatient care with no restrictions on the
number of visits or treatment content. In other words, the psychiatrists
in the study provided the best insurance-covered treatment they considered appropriate in a two-way video or face-to-face setting. In
addition, the study was validated in a modern telemedicine setting,
where patients easily accessed and received treatment from a psychiatrist at home or in the office using smartphones, tablets, or personal
computers. Most of the telemedicine RCTs to date have been relatively short-term trials for a single disorder, often with some form of
specific treatment. To our knowledge, there are very few pragmatic
RCTs validating two-way video treatment that incorporate multiple
psychiatric disorders.9 In addition, each trial design has limitations,
such as a limited follow-up period of less than 6 months11 or, in the
case of long-term follow-up studies, the number of participants is limited to a few dozen12 to 140.10 Through the COVID-19 pandemic,
two-way video appointments became established as a common
method of psychiatric care delivery. Patients can now easily see their
Psychiatry and Clinical Neurosciences
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
RCT of 24-week two-way video vs face-to-face treatment