Table 2 Comparison of data recorded in the eight RCTs. Summary of data recorded using the SEAR framework

T1

Patient initials, NHS number, age, gender, screening ID, date of qualifying intervention.

Screening criteria: Yes. Complete for all patients referred for Treatment X

Ineligible recorded as final screening outcome Reason for ineligibility (open response) Histology, pathology

Date two written information sheets provided Non-approach recorded as final screening outcome Reason for non-approach (open response)

Randomisation ID and allocation If not randomised, reason for non-participation (open response)

T2

Patient initials, gender, date of potential recruitment. Screening criteria: No

Reason for exclusion or ineligibility (using coded inclusion and exclusion criteria printed on back of the log)

Not recorded

Reason for eligible patients declining the trial (6 codes) Final treatment recorded for all screened participants Treatment preferences for eligible decliners

T3

Patient initials, age, screening ID, date screening initiated. Screening criteria: Yes. Complete for all patients with whom the trial is discussed.

Clinical data – nodal status (+/), tumour size Was the patient eligible? (Y/N) Reason for ineligibility (open response)

Not recorded

Consent (Y/N) for main and two substudies and participant ID Reason to decline main study and two substudies (open response) Final treatment received for all screened participants

T4

Patient initials, screening ID, age range, gender, MDT date. Screening criteria: Yes. Complete for all patients referred for Treatment X

MDT decision – potentially eligible (Y/N) and reason (open response); eligibility checked against each inclusion/exclusion criteria; Final MDT decision eligible (Y/N). If not, reason recorded (coded and/or open response).

‘Reason not eligible’ includes 3 coded responses why patient not approached

Randomisation ID Reason eligible patients decline trial (open response) Treatment received by non-randomised patients

T5

Patient initial, gender, age, hospital ID, referral from (5 codes). Screening criteria: No.

Eligible (Y/N)

Written information given (Y/N) Date trial discussed

Randomisation ID Patient consent (Y/N). If no, record reason Final treatment decision (non-randomised patients)

T6

Patient name, study ID, hospital number. Screening criteria: Complete for all patients referred for intervention X. Kept on site form – not entered into database if patient does not join the trial.

Eligibility (Y/N) against all trial inclusion/ exclusion criteria

Written information given (Y/N), date provided, reason not given (open response) Date of trial discussed Approached to participate in trial (Y/N) and reason not approached (open response) Coded when added to the study database

Reason eligible patient declined consent Final treatment decision (non-randomised patients) Coded when added to the study database

T7

Patient initials, date of birth, study number, gender, date of MDT decision, pathology. Screening criteria: Yes. 3 ‘initial’ trial eligibility criteria

Eligibility against all trial inclusion/exclusion criteria (Y/N). Reason for ineligibility (open response)

Patient invite to join study (Y/N). Reason (2 codes/open response)

Reason eligible patient declined trial (open response) Final treatment received (non-randomised patients)

T8

Patient initials, NHS no., date first screened. Screening criteria: Please enter all patients recommended by MDT as potentially eligible for Trial X

Inclusion/exclusion criteria met (Y/N) Reason for ineligibility

Provision of written information (Y/N) Approach consent for trial (Y/N)

Consent given (Y/N) Randomised (Y/N) Reason eligible patients declined (open response)