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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