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Table 2 Adaptations selected for in-depth discussion within semi-structured interviews

From: Learning from COVID-19 related trial adaptations to inform efficient trial design—a sequential mixed methods study

Group Adaptation Description
Recruitment adaptations Two-stage remote-first eligibility assessment A two-stage eligibility assessment, where eligibility is assessed remotely prior to an in-person eligibility assessment
Recruitment outside the NHS via a charity The use of charities to identify and contact potential participants
Remote consent (online or telephone) The gaining of consent remotely, either via telephone or online
Remote consent (postal) Where consent for participation in the trial is obtained through the participant sending the consent form via the postal service
Intervention delivery adaptations Couriering of the IMP to the participant Where the study drug is sent to the participant, rather than having to attend a pharmacy
Remote delivery of the intervention by CTU staff Where CTU remotely deliver the trial intervention, instead of site-based NHS staff
Outcome assessment adaptations Remote collection of PROMs, blood pressures and a measure of blood glucose Telephone or postal collection of PROMs, and remote collection of biological measures—blood pressures and a measure of blood glucose
Prioritisation of in-person assessments Where the trial team contact the participant prior to a scheduled in-person visit to ascertain the safety or necessity of undertaking the assessment
Prioritisation of in-person visits Where the need to collect trial outcomes is reviewed for the entire trial
Remote collection of spirometry and cough data Where spirometry and cough data are automatically collected by a device and sent to the study team
Collection of biological measures at another facility / use of routinely collected outcome measures Instead of collecting the measure directly from the participant, another routine source is instead used