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 (4 ページ)
出典
| 公開元URL | https://www8.cao.go.jp/kisei-kaikaku/kisei/meeting/wg/2310_04medical/231218/medical04_agenda.html |
| 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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Table 1 presents the baseline demographic and clinical characteristics of the participants. No significant differences were noted
between the two groups, including in terms of age, sex, disease duration, and total treatment period. In the two-way video group, the average percentage of two-way video use after baseline was 76.95%
22.93%. Of these, there were a total of 38 patients who utilized twoway video 100% of the time.
Primary Outcome
The SF-36 MCS scores at week 24 in the two-way video and faceto-face groups were 48.50 9.57 and 46.68 10.58, respectively. The
criteria for noninferiority, for which the margin was set as 5.0, were
met (mean between-treatment group difference, 1.82; 95% confidence
interval, 1.12 to 4.77; P < 0.0001) (Table 2). With regard to
Enrollment
Psychiatry and
Clinical Neurosciences
sensitivity analysis based on the PPS, the criteria for noninferiority
were also met, with a mean between-treatment group difference of 1.90
points (48.50 9.57 vs 46.60 10.62 in the two-way video and faceto-face groups, respectively [95% confidence interval, 1.06 to 4.86];
P < 0.0001). As a post hoc analysis, only the patients who utilized
two-way video 100% of the time were extracted. The SF-36 MCS
scores at week 24 for that group were 47.58 9.16, and the criteria for
noninferiority in the face-to-face group were also met (Supplementary
Table S1).
Secondary Outcomes
There was no significant difference between the two-way video and
face-to-face groups with regard to the SF-36 MCS score at week
12 (P = 0.38) or the SF-36 PCS scores at weeks 12 and 24 (Table 3).
Assessed for eligibilityand gave informed consent (n = 199)
Depressive disorders (n = 98)
Anxiety disorders (n = 66)
Obsessive compulsive and related disorders (n = 35)
Allocation
Allocated to two-way video (n = 105)
Depressive disorders (n = 53)
Anxiety disorders (n = 34)
Obsessive compulsive and related disorders
(n = 18)
Allocated to face-to-face (n = 94)
Depressive disorders (n = 45)
Anxiety disorders (n = 32)
Obsessive compulsive and related disorders
(n = 17)
Follow-up
Completed intervention (n = 97)
Discontinued intervention (n = 7)
⬪ Withdraw consent (n = 1)
⬪ Did not meet inclusion criteria (n = 1)
⬪ Adverse events (n = 1)
⬪ Patient’s request (n = 1)
⬪ Time commitment challenges (n = 1)
⬪ Other reasons (n = 2)
Completed intervention (n = 90)
Lost to follow-up (n = 3)
⬪ Lost to contact (n = 3)
Discontinued intervention (n = 1)
⬪ Withdraw consent (n = 1)
Analysis
Included in full analysis set (n = 98)
Depressive disorders (n = 50)
Anxiety disorders (n = 30)
Obsessive compulsive and related disorders
(n = 18)
Included in full analysis set (n = 90)
Depressive disorders (n = 42)
Anxiety disorders (n = 31)
Obsessive compulsive and related disorders
(n = 17)
Included in perprotocol set (n = 96)
Depressive disorders (n = 49)
Anxiety disorders (n = 29)
Obsessive compulsive and related disorders
(n = 18)
Included in per protocol set (n = 85)
Depressive disorders (n = 37)
Anxiety disorders (n = 31)
Obsessive compulsive and related disorders
(n = 17)
Fig. 1 CONSORT (Consolidated Standards of Reporting Trials) diagram of participant flow through the study.
4
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
between the two groups, including in terms of age, sex, disease duration, and total treatment period. In the two-way video group, the average percentage of two-way video use after baseline was 76.95%
22.93%. Of these, there were a total of 38 patients who utilized twoway video 100% of the time.
Primary Outcome
The SF-36 MCS scores at week 24 in the two-way video and faceto-face groups were 48.50 9.57 and 46.68 10.58, respectively. The
criteria for noninferiority, for which the margin was set as 5.0, were
met (mean between-treatment group difference, 1.82; 95% confidence
interval, 1.12 to 4.77; P < 0.0001) (Table 2). With regard to
Enrollment
Psychiatry and
Clinical Neurosciences
sensitivity analysis based on the PPS, the criteria for noninferiority
were also met, with a mean between-treatment group difference of 1.90
points (48.50 9.57 vs 46.60 10.62 in the two-way video and faceto-face groups, respectively [95% confidence interval, 1.06 to 4.86];
P < 0.0001). As a post hoc analysis, only the patients who utilized
two-way video 100% of the time were extracted. The SF-36 MCS
scores at week 24 for that group were 47.58 9.16, and the criteria for
noninferiority in the face-to-face group were also met (Supplementary
Table S1).
Secondary Outcomes
There was no significant difference between the two-way video and
face-to-face groups with regard to the SF-36 MCS score at week
12 (P = 0.38) or the SF-36 PCS scores at weeks 12 and 24 (Table 3).
Assessed for eligibilityand gave informed consent (n = 199)
Depressive disorders (n = 98)
Anxiety disorders (n = 66)
Obsessive compulsive and related disorders (n = 35)
Allocation
Allocated to two-way video (n = 105)
Depressive disorders (n = 53)
Anxiety disorders (n = 34)
Obsessive compulsive and related disorders
(n = 18)
Allocated to face-to-face (n = 94)
Depressive disorders (n = 45)
Anxiety disorders (n = 32)
Obsessive compulsive and related disorders
(n = 17)
Follow-up
Completed intervention (n = 97)
Discontinued intervention (n = 7)
⬪ Withdraw consent (n = 1)
⬪ Did not meet inclusion criteria (n = 1)
⬪ Adverse events (n = 1)
⬪ Patient’s request (n = 1)
⬪ Time commitment challenges (n = 1)
⬪ Other reasons (n = 2)
Completed intervention (n = 90)
Lost to follow-up (n = 3)
⬪ Lost to contact (n = 3)
Discontinued intervention (n = 1)
⬪ Withdraw consent (n = 1)
Analysis
Included in full analysis set (n = 98)
Depressive disorders (n = 50)
Anxiety disorders (n = 30)
Obsessive compulsive and related disorders
(n = 18)
Included in full analysis set (n = 90)
Depressive disorders (n = 42)
Anxiety disorders (n = 31)
Obsessive compulsive and related disorders
(n = 17)
Included in perprotocol set (n = 96)
Depressive disorders (n = 49)
Anxiety disorders (n = 29)
Obsessive compulsive and related disorders
(n = 18)
Included in per protocol set (n = 85)
Depressive disorders (n = 37)
Anxiety disorders (n = 31)
Obsessive compulsive and related disorders
(n = 17)
Fig. 1 CONSORT (Consolidated Standards of Reporting Trials) diagram of participant flow through the study.
4
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