Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology

  1. Taishiro Kishimoto
  2. Shotaro Kinoshita
  3. Shogyoku Bun
  4. Yasunori Sato
  5. Momoko Kitazawa
  6. Toshiaki Kikuchi
  7. Mitsuhiro Sado
  8. Akihiro Takamiya
  9. Masaru Mimura
  10. Takashi Nakamae
  11. Yoshinari Abe
  12. Tetsufumi Kanazawa
  13. Yasuo Kawabata
  14. Hiroaki Tomita
  15. Koichi Abe
  16. Akitoyo Hishimoto
  17. Takeshi Asami
  18. Akira Suda
  19. Yoshinori Watanabe
  20. Toru Amagai
  21. Kei Sakuma
  22. Hisashi Kida
  23. Michitaka Funayama
  24. Hiroshi Kimura
  25. Aiko Sato
  26. Shuichiro Fujiwara
  27. Kiichiro Nagao
  28. Naoya Sugiyama
  29. Maki Takamiya
  30. Hideyuki Kodama
  31. Takaharu Azekawa

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Abstract

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  1. Version published to 10.1016/j.cct.2021.106596
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    SciScore for 10.1101/2021.06.23.21259366: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsConsent: The inclusion criteria for participants will be as follows: 1) patients who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for depressive disorders, anxiety disorders, or OCD and related disorders and are outpatients at a participating medical institution; 2) patients who are 18 years old or older at the time of obtaining consent; 3) patients who need continuous treatment for the next 6 months or more (at the discretion of the attending physician); 4) patients who have a smart phone or PC and have access to video calling over the Internet (even if it is only available with family support); 5) patients whose psychiatric conditions are stable enough to receive telepsychiatry by clinical judgement of the attending physician; 6) patients whose psychiatric conditions are stable enough to have sufficient capacity provide consent by clinical judgement of the attending physician; and 7) patients who have provided written consent to participate in the study.
    Sex as a biological variableIn this study, to avoid inter-institutional differences and biases in the types of disorders among the groups, randomization process is carried out by a blinded, independent third party using a modified minimization method with a biased-coin assignment balanced for age group (60 years old or older, or younger), gender (male or female), target disorder, and participating institution.
    RandomizationThe main objective of this study will be to show that the telepsychiatry group is non-inferior to the FTF group after 6 months of practice in patients with depressive disorder, anxiety disorder, or OCD and related disorders. 2.2. Participants: This study will be a multi-site, prospective randomized controlled trial.
    BlindingIn this study, to avoid inter-institutional differences and biases in the types of disorders among the groups, randomization process is carried out by a blinded, independent third party using a modified minimization method with a biased-coin assignment balanced for age group (60 years old or older, or younger), gender (male or female), target disorder, and participating institution.
    Power AnalysisIn the present study, assuming that the SF36MCS of the telemedicine and FTF groups at 6 months is 45 (no difference between the two groups), with a standard deviation of 12, and a non-inferiority margin of 5, the required number of patients in each group would be 92 under the conditions of 80% power and a one-sided significance level of 2.5%.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    All statistical analyses will be performed using the SAS software version 9.4 (SAS Institute, Cary, NC, USA).
    SAS
    suggested: (SASqPCR, RRID:SCR_003056)
    SAS Institute
    suggested: (Statistical Analysis System, RRID:SCR_008567)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    The limitations of this study are as follows. First, we targeted three disorder groups, namely depressive disorders, anxiety disorders, and OCD and related disorders. In addition to targeting three disorders in one trial, the demographic characteristics of the participants may vary over a wide range. This may lead to difficulty in finding a comparative effect size of telemedicine; however, this is an inherent difficulty of pragmatic trials, and limiting participation to a specific patient population may limit the generalizability of the results. Related to this point, IT literacy might be the largest modulator of the results, and since Japan is a world-leading aging society, this fact is of particular consideration. Elderly people generally experience more hurdles to telemedicine because of IT literacy issues [20]. By randomizing the whole population, we reduce the risk of the impact of this possible modulator. At the same time, by asking the participants regarding their impressions or hurdles regarding telemedicine utilization in a free-answer format, we hope to gather information that will enable us to help elderly or low-IT literacy patients to take advantage of telemedicine in the future. Finally, the implementation of this study may be affected by the status of the COVID-19 pandemic. If the pandemic becomes serious, there is a risk that hospitals will suspend FTF treatment or that patients will refuse to come to the hospital for fear of the risk of infection. In any case...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.06.23.21259366v1 on medRxiv