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The practice of active patient involvement in rare disease research using ICT: experiences and lessons from the RUDY JAPAN project

BACKGROUND: The role of patients in medical research is changing, as more emphasis is being placed on patient involvement, and patient reported outcomes are increasingly contributing to clinical decision-making. Information and communication technology provides new opportunities for patients to acti...

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Autores principales: Hamakawa, Nao, Kogetsu, Atsushi, Isono, Moeko, Yamasaki, Chisato, Manabe, Shirou, Takeda, Toshihiro, Iwamoto, Kazumasa, Kubota, Tomoya, Barrett, Joe, Gray, Nathanael, Turner, Alison, Teare, Harriet, Imamura, Yukie, Yamamoto, Beverley Anne, Kaye, Jane, Hide, Michihiro, Takahashi, Masanori P., Matsumura, Yasushi, Javaid, Muhammad Kassim, Kato, Kazuto
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7852111/
https://www.ncbi.nlm.nih.gov/pubmed/33526087
http://dx.doi.org/10.1186/s40900-021-00253-6
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author Hamakawa, Nao
Kogetsu, Atsushi
Isono, Moeko
Yamasaki, Chisato
Manabe, Shirou
Takeda, Toshihiro
Iwamoto, Kazumasa
Kubota, Tomoya
Barrett, Joe
Gray, Nathanael
Turner, Alison
Teare, Harriet
Imamura, Yukie
Yamamoto, Beverley Anne
Kaye, Jane
Hide, Michihiro
Takahashi, Masanori P.
Matsumura, Yasushi
Javaid, Muhammad Kassim
Kato, Kazuto
author_facet Hamakawa, Nao
Kogetsu, Atsushi
Isono, Moeko
Yamasaki, Chisato
Manabe, Shirou
Takeda, Toshihiro
Iwamoto, Kazumasa
Kubota, Tomoya
Barrett, Joe
Gray, Nathanael
Turner, Alison
Teare, Harriet
Imamura, Yukie
Yamamoto, Beverley Anne
Kaye, Jane
Hide, Michihiro
Takahashi, Masanori P.
Matsumura, Yasushi
Javaid, Muhammad Kassim
Kato, Kazuto
author_sort Hamakawa, Nao
collection PubMed
description BACKGROUND: The role of patients in medical research is changing, as more emphasis is being placed on patient involvement, and patient reported outcomes are increasingly contributing to clinical decision-making. Information and communication technology provides new opportunities for patients to actively become involved in research. These trends are particularly noticeable in Europe and the US, but less obvious in Japan. The aim of this study was to investigate the practice of active involvement of patients in medical research in Japan by utilizing a digital platform, and to analyze the outcomes to clarify what specific approaches could be put into practice. METHODS: We developed the RUDY JAPAN system, an ongoing rare disease medical research platform, in collaboration with the Rare and Undiagnosed Diseases Study (RUDY) project in the UK. After 2 years of preparation, RUDY JAPAN was launched in December 2017. Skeletal muscle channelopathies were initially selected as target diseases, and hereditary angioedema was subsequently added. Several approaches for active patient involvement were designed through patient-researcher collaboration, namely the Steering Committee, questionnaire development, dynamic consent, and other communication strategies. We analyzed our practices and experiences focusing on how each approach affected and contributed to the research project. RESULTS: RUDY JAPAN has successfully involved patients in this research project in various ways. While not a part of the initial decision-making phase to launch the project, patients have increasingly been involved since then. A high level of patient involvement was achieved through the Steering Committee, a governance body that has made a major contribution to RUDY JAPAN, and the process of the questionnaire development. The creation of the Patient Network Forum, website and newsletter cultivated dialogue between patients and researchers. The registry itself allowed patient participation through data input and control of data usage through dynamic consent. CONCLUSIONS: We believe the initial outcomes demonstrate the feasibility and utility of active patient involvement in Japan. The collaboration realized through RUDY JAPAN was enabled by digital technologies. It allowed busy patients and researchers to find the space to meet and work together for the Steering Committee, questionnaire development and various communication activities. While the practice of active patient involvement in Japan is still in its early stages, this research confirms its viability if the right conditions are in place. (331 words).
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spelling pubmed-78521112021-02-03 The practice of active patient involvement in rare disease research using ICT: experiences and lessons from the RUDY JAPAN project Hamakawa, Nao Kogetsu, Atsushi Isono, Moeko Yamasaki, Chisato Manabe, Shirou Takeda, Toshihiro Iwamoto, Kazumasa Kubota, Tomoya Barrett, Joe Gray, Nathanael Turner, Alison Teare, Harriet Imamura, Yukie Yamamoto, Beverley Anne Kaye, Jane Hide, Michihiro Takahashi, Masanori P. Matsumura, Yasushi Javaid, Muhammad Kassim Kato, Kazuto Res Involv Engagem Research Article BACKGROUND: The role of patients in medical research is changing, as more emphasis is being placed on patient involvement, and patient reported outcomes are increasingly contributing to clinical decision-making. Information and communication technology provides new opportunities for patients to actively become involved in research. These trends are particularly noticeable in Europe and the US, but less obvious in Japan. The aim of this study was to investigate the practice of active involvement of patients in medical research in Japan by utilizing a digital platform, and to analyze the outcomes to clarify what specific approaches could be put into practice. METHODS: We developed the RUDY JAPAN system, an ongoing rare disease medical research platform, in collaboration with the Rare and Undiagnosed Diseases Study (RUDY) project in the UK. After 2 years of preparation, RUDY JAPAN was launched in December 2017. Skeletal muscle channelopathies were initially selected as target diseases, and hereditary angioedema was subsequently added. Several approaches for active patient involvement were designed through patient-researcher collaboration, namely the Steering Committee, questionnaire development, dynamic consent, and other communication strategies. We analyzed our practices and experiences focusing on how each approach affected and contributed to the research project. RESULTS: RUDY JAPAN has successfully involved patients in this research project in various ways. While not a part of the initial decision-making phase to launch the project, patients have increasingly been involved since then. A high level of patient involvement was achieved through the Steering Committee, a governance body that has made a major contribution to RUDY JAPAN, and the process of the questionnaire development. The creation of the Patient Network Forum, website and newsletter cultivated dialogue between patients and researchers. The registry itself allowed patient participation through data input and control of data usage through dynamic consent. CONCLUSIONS: We believe the initial outcomes demonstrate the feasibility and utility of active patient involvement in Japan. The collaboration realized through RUDY JAPAN was enabled by digital technologies. It allowed busy patients and researchers to find the space to meet and work together for the Steering Committee, questionnaire development and various communication activities. While the practice of active patient involvement in Japan is still in its early stages, this research confirms its viability if the right conditions are in place. (331 words). BioMed Central 2021-02-01 /pmc/articles/PMC7852111/ /pubmed/33526087 http://dx.doi.org/10.1186/s40900-021-00253-6 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Hamakawa, Nao
Kogetsu, Atsushi
Isono, Moeko
Yamasaki, Chisato
Manabe, Shirou
Takeda, Toshihiro
Iwamoto, Kazumasa
Kubota, Tomoya
Barrett, Joe
Gray, Nathanael
Turner, Alison
Teare, Harriet
Imamura, Yukie
Yamamoto, Beverley Anne
Kaye, Jane
Hide, Michihiro
Takahashi, Masanori P.
Matsumura, Yasushi
Javaid, Muhammad Kassim
Kato, Kazuto
The practice of active patient involvement in rare disease research using ICT: experiences and lessons from the RUDY JAPAN project
title The practice of active patient involvement in rare disease research using ICT: experiences and lessons from the RUDY JAPAN project
title_full The practice of active patient involvement in rare disease research using ICT: experiences and lessons from the RUDY JAPAN project
title_fullStr The practice of active patient involvement in rare disease research using ICT: experiences and lessons from the RUDY JAPAN project
title_full_unstemmed The practice of active patient involvement in rare disease research using ICT: experiences and lessons from the RUDY JAPAN project
title_short The practice of active patient involvement in rare disease research using ICT: experiences and lessons from the RUDY JAPAN project
title_sort practice of active patient involvement in rare disease research using ict: experiences and lessons from the rudy japan project
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7852111/
https://www.ncbi.nlm.nih.gov/pubmed/33526087
http://dx.doi.org/10.1186/s40900-021-00253-6
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