| dc.description.abstract | Background: During the COVID-19 pandemic, many healthcare services were carried out digitally, limiting access of vulnerable populations to healthcare due to inequitable technology access and low digital literacy known as the digital divide. Similarly, increased technology use in decentralised clinical trials (DCTs) may limit access to clinical trials affecting diversity. Currently, the digital skill requirements of DCTs are unknown, which limits further assessments of implications on diversity.
Methods: Six semi-structured interviews were conducted to develop an initial list of digital competencies. A three-round modified Delphi study was performed with 27 panel members. Skills were rated on a 5-point Likert scale and lists were built for five decentralised clinical trial elements: online recruitment and screening, remote consent, telemedicine, trial applications, and remote measurement devices of digital competencies. Consensus criteria was based on the interquartile range and skills were classified as “critical skills”, “not critical skills” and “not required skills” based on their median scores. Additionally, a list of fundamental digital skills for effective participation in clinical trials was constructed by asking panel members to choose the five most important skills out of all the skills listed in the study with cut-off points at 50% and 25%. All identified skills were mapped on the European Digital Competence Framework for Citizens (DigComp) to identify the major required digital competence areas.
Results: In total 57 skills were identified: 33 skills were rated critical, 17 skills not critical and 7 skills not required. Two main themes emerged from the received feedback: 1) skill requirements are dependent on the specific tool, and 2) the relevancy of a skill depends on the trial. In total, 12 skills were listed for the fundamental digital skills required for effective participation, of which 6 were chosen by the majority: ability to create and sign-in to an account in a mobile device application or computer software, ability to fill out online forms, ability to share information through applications (e.g., entering data, filling in an e-diary), ability to connect a device to the internet, ability to recognise lack of internet connection, ability to connect one or more Bluetooth devices to a mobile device. Mapping of skills to DigComp showed that required skills mostly fall into 1) device and software operations, 2) information and data literacy and 3) communication and collaboration competence areas.
Conclusion: To our knowledge, this study is the first attempt to identify digital skills required in DCTs and map these to DigComp. The required proficiency level was identified as the “foundation” level according to the framework. One exception to this was skills identified for online recruitment and screening, where participants may need to be able to find a clinical trial and leave their contact details autonomously. In line with this finding, critical skills for online recruitment and screening were all listed in the fundamental digital skills for DCTs. This list also included skills that may have an impact on data integrity, such as using charging devices, and ensuring connectivity (e.g., Bluetooth, internet). Currently, it is not possible to conclude if the digital divide may impact trial population diversity. However, the findings of this research can be used to navigate existing statistical data to assess the vulnerability of a target population, enabling the incorporation of certain design elements into the clinical trial protocol, to bridge the potential digital divide. | |
