The factors affecting implementing shared decision-making in clinical trials: a cross-sectional survey of clinical research coordinators’ perceptions in Japan
Abstract Background The shared decision-making model has been proposed as the ideal treatment decision-making process in medical encounters. However, the decision to participate in clinical trials rarely involves shared decision-making. In this study, we investigated the perceptions of Japanese clin...
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| Format: | Article |
| Language: | English |
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BMC
2023-02-01
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| Series: | BMC Medical Informatics and Decision Making |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12911-023-02138-y |
| _version_ | 1797864519680131072 |
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| author | Miho Fujita Yuki Yonekura Kazuhiro Nakayama |
| author_facet | Miho Fujita Yuki Yonekura Kazuhiro Nakayama |
| author_sort | Miho Fujita |
| collection | DOAJ |
| description | Abstract Background The shared decision-making model has been proposed as the ideal treatment decision-making process in medical encounters. However, the decision to participate in clinical trials rarely involves shared decision-making. In this study, we investigated the perceptions of Japanese clinical research coordinators who routinely support the informed consent process. Methods This study aimed to (1) identify clinical research coordinators’ perceptions of the current status of shared decision-making implementation and its influencing factors, and (2) obtain suggestions to enhance the shared decision-making process in clinical trials. A cross-sectional survey was conducted using a web questionnaire based on the Theory of Planned behaviour. Invitations were sent to 1087 Japanese medical institutions, and responses from the participants were captured via the web. The shared decision-making process in clinical trials was defined according to the Shared Decision-Making Questionnaire for Doctors. The effect of the attitudes toward shared decision-making, clinical research coordinators’ subjective norms towards its implementation, perceived barriers to autonomous decision-making, and the number of difficult steps in the shared decision-making process on the shared decision-making current status as the shared decision-making intention was assessed by multiple regression analysis. Results In total, 373 clinical research coordinators responded to the questionnaire. Many believed that they were already implementing shared decision-making. Attitudes toward shared decision-making (t = 3.400, p < .001), clinical research coordinators’ subjective norms towards its implementation (t = 2.239, p = .026), perceived barriers to autonomous decision-making (t = 3.957, p < .001), and the number of difficult steps in the shared decision-making process (t = 3.317, p = .001) were found to significantly influence current status (Adjusted R 2 = .123). However, results on perceived barriers to autonomous decision-making and the number of difficult steps in the shared decision-making process indicate a lack of knowledge of shared decision-making and decision-support skills among clinical research coordinators. Conclusions Clinical research coordinators might positively perceive shared decision-making based on normative beliefs without sufficient knowledge of it. Therefore, providing appropriate training on shared decision-making to clinical research coordinators and increasing awareness among stakeholders could enable its improvement. Trial registration Not applicable. |
| first_indexed | 2024-04-09T22:53:13Z |
| format | Article |
| id | doaj.art-c2977a10cdfe4e10a1e05b168ffc973f |
| institution | Directory Open Access Journal |
| issn | 1472-6947 |
| language | English |
| last_indexed | 2024-04-09T22:53:13Z |
| publishDate | 2023-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Informatics and Decision Making |
| spelling | doaj.art-c2977a10cdfe4e10a1e05b168ffc973f2023-03-22T11:31:38ZengBMCBMC Medical Informatics and Decision Making1472-69472023-02-0123111110.1186/s12911-023-02138-yThe factors affecting implementing shared decision-making in clinical trials: a cross-sectional survey of clinical research coordinators’ perceptions in JapanMiho Fujita0Yuki Yonekura1Kazuhiro Nakayama2Clinical Research Support Office, Showa University Northern Yokohama HospitalGraduate School of Nursing Science, St. Luke’s International UniversityGraduate School of Nursing Science, St. Luke’s International UniversityAbstract Background The shared decision-making model has been proposed as the ideal treatment decision-making process in medical encounters. However, the decision to participate in clinical trials rarely involves shared decision-making. In this study, we investigated the perceptions of Japanese clinical research coordinators who routinely support the informed consent process. Methods This study aimed to (1) identify clinical research coordinators’ perceptions of the current status of shared decision-making implementation and its influencing factors, and (2) obtain suggestions to enhance the shared decision-making process in clinical trials. A cross-sectional survey was conducted using a web questionnaire based on the Theory of Planned behaviour. Invitations were sent to 1087 Japanese medical institutions, and responses from the participants were captured via the web. The shared decision-making process in clinical trials was defined according to the Shared Decision-Making Questionnaire for Doctors. The effect of the attitudes toward shared decision-making, clinical research coordinators’ subjective norms towards its implementation, perceived barriers to autonomous decision-making, and the number of difficult steps in the shared decision-making process on the shared decision-making current status as the shared decision-making intention was assessed by multiple regression analysis. Results In total, 373 clinical research coordinators responded to the questionnaire. Many believed that they were already implementing shared decision-making. Attitudes toward shared decision-making (t = 3.400, p < .001), clinical research coordinators’ subjective norms towards its implementation (t = 2.239, p = .026), perceived barriers to autonomous decision-making (t = 3.957, p < .001), and the number of difficult steps in the shared decision-making process (t = 3.317, p = .001) were found to significantly influence current status (Adjusted R 2 = .123). However, results on perceived barriers to autonomous decision-making and the number of difficult steps in the shared decision-making process indicate a lack of knowledge of shared decision-making and decision-support skills among clinical research coordinators. Conclusions Clinical research coordinators might positively perceive shared decision-making based on normative beliefs without sufficient knowledge of it. Therefore, providing appropriate training on shared decision-making to clinical research coordinators and increasing awareness among stakeholders could enable its improvement. Trial registration Not applicable.https://doi.org/10.1186/s12911-023-02138-yShared decision-makingImplementationClinical trialClinical research coordinators’ perceptionThe Theory of Planned behaviourSDM-Q-Doc |
| spellingShingle | Miho Fujita Yuki Yonekura Kazuhiro Nakayama The factors affecting implementing shared decision-making in clinical trials: a cross-sectional survey of clinical research coordinators’ perceptions in Japan BMC Medical Informatics and Decision Making Shared decision-making Implementation Clinical trial Clinical research coordinators’ perception The Theory of Planned behaviour SDM-Q-Doc |
| title | The factors affecting implementing shared decision-making in clinical trials: a cross-sectional survey of clinical research coordinators’ perceptions in Japan |
| title_full | The factors affecting implementing shared decision-making in clinical trials: a cross-sectional survey of clinical research coordinators’ perceptions in Japan |
| title_fullStr | The factors affecting implementing shared decision-making in clinical trials: a cross-sectional survey of clinical research coordinators’ perceptions in Japan |
| title_full_unstemmed | The factors affecting implementing shared decision-making in clinical trials: a cross-sectional survey of clinical research coordinators’ perceptions in Japan |
| title_short | The factors affecting implementing shared decision-making in clinical trials: a cross-sectional survey of clinical research coordinators’ perceptions in Japan |
| title_sort | factors affecting implementing shared decision making in clinical trials a cross sectional survey of clinical research coordinators perceptions in japan |
| topic | Shared decision-making Implementation Clinical trial Clinical research coordinators’ perception The Theory of Planned behaviour SDM-Q-Doc |
| url | https://doi.org/10.1186/s12911-023-02138-y |
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