Table 4 Benefits, pitfalls, challenges and enablers of Remote Trial Delivery
Benefits | Pitfalls | Challenges | Enablers | |
|---|---|---|---|---|
Participant experience | Broader reach and inclusivity (in IT-enabled groups); increased research opportunity Flexibility in study delivery, increased convenience (e.g. not having to arrange transport and parking at the study site) Reduced infection risk Socially or geographically targeted recruitment | The impression of being “alone” (unsupported) Reduced contact with the study team might impact on retention Potential for non-compliance (intentional and unintentional) Potential for bias (e.g. due to limitations in remote communication e.g. computer literacy (digital divide, age-related/socioeconomic), literacy, audio-visual impairments) Reduced ability to ask questions or seek clarification Loss of non-verbal communication/difficulty with holistic assessment | Digital infrastructure and literacy Pathways to approach potential participants/care partners Adaptations required for inclusivity—e.g. hearing, visual or cognitive impairment Failure to maintain participant engagement Communication, including post-trial | Digital infrastructure and literacy Provision of guidance and support with technology and trouble-shooting Ensuring participant well-prepared and followed up regularly Provision of guidance and training on protocol adherence Peer support opportunities for participants (e.g. virtual coffee mornings) Safety net of regular video contact Clear route for communicating with the study team |
Infrastructure and processes | Can be standardised/centralised Improved efficiency | Threat to privacy/confidentiality Data security Protocol compliance more difficult to assess | Outdated NHS IT systems (NHS IT—National Health Service Information Technology) Quality control/standardisation harder to ensure in diverse environments More resource-demanding Increased preparation time for remote monitoring Variation in information governance processes and standards Maintenance of essential documentation | Electronic patient/medical record/HSCN (Health and Social Care Network) Standardised processes (e.g. FHIR Fast Healthcare Interoperability Resources) Approved e-consent process Central coordination Consent and ethics approval in place for remote monitoring Flexible mindset within organisations Experienced workforce with appropriate skills |
Assessments and interventions | Greater ecological validity Potentially greater clinical validity than “snap-shot” in-clinic assessments Captured with greater granularity Reduced data capture error Reduced risk of research fraud More efficient data analysis | May not be validated Potential for reduced safety assessments Potential for increased heterogeneity within measurements | Unsupervised environment for delivery Requirement for demonstration of validity/equivalence Need to be acceptable to regulators Lack of staff familiarity Should be feasible and acceptable to patients Not all interventions can be delivered remotely | Developed and validated for remote delivery Equivalence to traditional measure demonstrated |