Feasibility metric | Feasibility measure | Key feasibility criteria |
---|---|---|
Process: | ||
 Recruitment | Response to recruitment strategies | Proportion remaining interested in the study after provided study information and completing eligibility screening. |
 Refusal | Total number of eligible participants declining to participate | Proportion who met eligibility criteria but did not consent to participate. |
 Enrolment | Total number of participants enrolled | Enrol 50 participants in 8 months. |
 Retention | Total number of participants completing the protocol | Completed protocol in 35 participants (70%). Drop-out rates reported in similar studies are ~ 30%, and sample sizes between 24 and 50 have been previously recommended for feasibility studies [22, 23]. |
Resources: | ||
 Compliance with data collection protocol | Weighed food record with concurrent pain and mood measures. Sleep log. GENEActiv wear time | Complete entries for 75% of participants who complete the protocol. A complete entry will include date and time of day of each eating occasion, food, and beverage intake (food and amount), with concurrent pain VAS and mood VAS rating, completed sleep log, and at least 4 days of ~ 20 h of GENEActiv wear time. |
Scientific: | ||
 Safety | Questionnaire | Absence of adverse effects. |
 Participant’s view on intervention | Exit survey | Proportion of participants reporting that self-reported data collection processes were burdensome. Proportion of participants satisfied with study setting and procedures (responding neutral and above). |
 Research identified as appropriate for the target group | Food-related behaviours questionnaire | Participant responses identify pain influences diet (proportion reporting agreement with statements). |