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      The Evaluation of Web-Based Communication Interventions to Support Decisions About COVID-19 Vaccination Among Patients With Underlying Medical Conditions: Protocol for a Randomized Controlled Trial

      , PhD 1 , 2 , , MD 3 , , PhD 4 , , MPH 5 , , PhD 6 ,
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      COVID-19, vaccine, decision-making, randomized controlled trial, patient decision aid

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          The timeliness of raising vaccine acceptance and uptake among the public is essential to overcoming COVID-19; however, the decision-making process among patients with underlying medical conditions is complex, leading individuals to vaccine hesitancy because of their health status. Although vaccine implementation is more effective when deployed as soon as possible, vaccine hesitancy is a significant threat to the success of vaccination programs.


          This study aims to evaluate the effectiveness of a communication tool for patients with underlying medical conditions who should decide whether to receive a COVID-19 vaccine.


          This 3-arm prospective randomized controlled trial will test the effect of the developed communication intervention, which is fully automated, patient decision aid ( SMART-DA), and user-centered information ( SMART-DA-α). The web-based intervention was developed to help decision-making regarding COVID-19 vaccination among patients with underlying medical conditions. Over 450 patients will be enrolled on the web from a closed panel access website and randomly assigned to 1 of 3 equal groups stratified by their underlying disease, sex, age, and willingness to receive a COVID-19 vaccine. SMART-DA-α provides additional information targeted at helping patients’ decision-making regarding COVID-19 vaccination. Implementation outcomes are COVID-19 vaccination intention, vaccine knowledge, decisional conflict, stress related to decision-making, and attitudes toward vaccination, and was self-assessed through questionnaires.


          This study was funded in 2020 and approved by the Clinical Research Information Service, Republic of Korea. Data were collected from December 2021 to January 2022. This paper was initially submitted before data analysis. The results are expected to be published in the winter of 2023.


          We believe that the outcomes of this study will provide valuable new insights into the potential of decision aids for supporting informed decision-making regarding COVID-19 vaccination and discovering the barriers to making informed decisions regarding COVID-19 vaccination, especially among patients with underlying medical conditions. This study will provide knowledge about the common needs, fears, and perceptions concerning vaccines among patients, which can help tailor information for individuals and develop policies to support them.

          Trial Registration

          Korea Clinical Information Service KCT0006945; https://cris.nih.go.kr/cris/search/detailSearch.do/20965

          International Registered Report Identifier (IRRID)


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          Most cited references39

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          Knowledge, attitudes, and practices towards COVID-19 among Chinese residents during the rapid rise period of the COVID-19 outbreak: a quick online cross-sectional survey

          Unprecedented measures have been adopted to control the rapid spread of the ongoing COVID-19 epidemic in China. People's adherence to control measures is affected by their knowledge, attitudes, and practices (KAP) towards COVID-19. In this study, we investigated Chinese residents' KAP towards COVID-19 during the rapid rise period of the outbreak. An online sample of Chinese residents was successfully recruited via the authors' networks with residents and popular media in Hubei, China. A self-developed online KAP questionnaire was completed by the participants. The knowledge questionnaire consisted of 12 questions regarding the clinical characteristics and prevention of COVID-19. Assessments on residents' attitudes and practices towards COVID-19 included questions on confidence in winning the battle against COVID-19 and wearing masks when going out in recent days. Among the survey completers (n=6910), 65.7% were women, 63.5% held a bachelor degree or above, and 56.2% engaged in mental labor. The overall correct rate of the knowledge questionnaire was 90%. The majority of the respondents (97.1%) had confidence that China can win the battle against COVID-19. Nearly all of the participants (98.0%) wore masks when going out in recent days. In multiple logistic regression analyses, the COVID-19 knowledge score (OR: 0.75-0.90, P<0.001) was significantly associated with a lower likelihood of negative attitudes and preventive practices towards COVID-2019. Most Chinese residents of a relatively high socioeconomic status, in particular women, are knowledgeable about COVID-19, hold optimistic attitudes, and have appropriate practices towards COVID-19. Health education programs aimed at improving COVID-19 knowledge are helpful for Chinese residents to hold optimistic attitudes and maintain appropriate practices. Due to the limited sample representativeness, we must be cautious when generalizing these findings to populations of a low socioeconomic status.
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            Developing a quality criteria framework for patient decision aids: online international Delphi consensus process.

            To develop a set of quality criteria for patient decision support technologies (decision aids). Two stage web based Delphi process using online rating process to enable international collaboration. Individuals from four stakeholder groups (researchers, practitioners, patients, policy makers) representing 14 countries reviewed evidence summaries and rated the importance of 80 criteria in 12 quality domains on a 1 to 9 scale. Second round participants received feedback from the first round and repeated their assessment of the 80 criteria plus three new ones. Aggregate ratings for each criterion calculated using medians weighted to compensate for different numbers in stakeholder groups; criteria rated between 7 and 9 were retained. 212 nominated people were invited to participate. Of those invited, 122 participated in the first round (77 researchers, 21 patients, 10 practitioners, 14 policy makers); 104/122 (85%) participated in the second round. 74 of 83 criteria were retained in the following domains: systematic development process (9/9 criteria); providing information about options (13/13); presenting probabilities (11/13); clarifying and expressing values (3/3); using patient stories (2/5); guiding/coaching (3/5); disclosing conflicts of interest (5/5); providing internet access (6/6); balanced presentation of options (3/3); using plain language (4/6); basing information on up to date evidence (7/7); and establishing effectiveness (8/8). Criteria were given the highest ratings where evidence existed, and these were retained. Gaps in research were highlighted. Developers, users, and purchasers of patient decision aids now have a checklist for appraising quality. An instrument for measuring quality of decision aids is being developed.
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              Validation of a Decisional Conflict Scale


                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                19 January 2023
                19 January 2023
                : 12
                : e42837
                [1 ] Institute of Health and Environment Seoul National University Seoul Republic of Korea
                [2 ] Department of Dental Education Seoul National University Seoul Republic of Korea
                [3 ] Department of Family Medcine SMG-SNU Boramae Medical Center Seoul Republic of Korea
                [4 ] Division of Social Welfare and Health Administration Wonkwang University Ik-san Republic of Korea
                [5 ] Department of Public Health Sciences Graduate School of Public Health Seoul National University Seoul Republic of Korea
                [6 ] Department of Environmental Health Korea National Open University Seoul Republic of Korea
                Author notes
                Corresponding Author: Young-Il Jung extra012@ 123456knou.ac.kr
                Author information
                ©Minjung Lee, Bumjo Oh, Nan-He Yoon, Shinkyeong Kim, Young-Il Jung. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 19.01.2023.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 20 September 2022
                : 17 October 2022
                : 30 December 2022
                : 3 January 2023

                covid-19,vaccine,decision-making,randomized controlled trial,patient decision aid


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