Study of the effectiveness and safety of treatments to help patients with anaemia recover from major emergency surgery. Perioperative Iron and ESA Intervention Study (POP-I).

Approved 16/10/2023, London - Hampstead Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8248; hampstead.rec@hra.nhs.uk), ref: 23/LO/0425

Days at home at 30 days (DAH30). Reported by participants or their personal legal representative or other person with close knowledge of the participant (e.g. staff from a nursing home), DAH30 is an integer between 0 and 30 that reflects, out of the 30 days following randomisation, the total number of those days that the participant spends alive and at home. DAH30 is derived by subtracting from 30 the duration of initial length of stay following randomisation, as well as the duration of any further readmissions (to hospital or elsewhere) in the first 30 days. All days spent not at home, other than holidays, are also subtracted. These include moving house to more dependent living, time spent with relatives, etc. If a participant never returns home or dies at any point within the first 30 days, they will be assigned a score of 0.

1. EQ-5D-5L. Reported by participants or their personal legal representative or other person with close knowledge of the participant (e.g. staff from a nursing home), the EuroQol-5 Dimension-5 Level (EQ-5D-5L) health status measure is a widely used generic instrument for describing and valuing health states. Measured at baseline, day 30, day 120.
2. NHFD Residential Status. Obtained from medical records at discharge. Categorised using the same ordinal scale as used by the NHFD: (1) own home/sheltered housing, (2) residential care, (3) nursing care, (4) rehabilitation unit – hospital bed in the current trust, (5) rehabilitation unit – hospital bed in another trust, (6) rehabilitation unit – NHS funded care home bed, and (7) acute hospital. Measured at discharge, day 30, day 120.
3. Walking Performance. Reported by participants or their personal legal representative or other person with close knowledge of the participant (e.g. staff from a nursing home), using the ‘New Mobility Score’, which has been utilised by the National Hip Fracture Database (NHFD). Measured at day 30, day 120.
4. Length of Stay. Length of stay is an integer that describes the number of days a patient was in hospital following randomisation. Calculated by obtaining the date of discharge from hospital records and then counting the number of nights between this date and the date of randomisation (obtained from study records). Measured at discharge, day 30, day 120.
5. Complications. Medical records for all patients will be reviewed by appropriately trained staff for indicators of infection at the time of the patient’s discharge from the recruiting site. In addition, for those patients who have left hospital, the patients will self-report (via an online form, telephone interview or by post, at 30 and 120 days after randomisation) on any of the complications listed below. For those patients lacking capacity, their personal legal representative or other person with close knowledge of the participant (e.g. staff from a nursing home) will be asked to provide this information. Measured at discharge, day 30, day 120.
6. Hospital Resource/Cost Data. Obtained from hospital records, this measure defines the resources and cost associated with a patient’s hospital episode. Measured at discharge.
7. Days alive and out of hospital at 30 days. Obtained from hospital records, ‘Days alive and out of hospital’ (DAOH30) is an integer between 0 and 30 which reflects, out of the 30 days following randomisation, the total number of those days that the participant spends alive and out of hospital. It is computed using Hospital Episode Statistics – Admitted Patient Care (HES-APC) which captures date of discharge and readmissions within 30 days.
8. Health Resource Use Questionnaire – Post intervention costs healthcare/ social and societal. Reported by participants or their personal legal representative or other person with close knowledge of the participant (e.g. staff from a nursing home), this will be a purposely designed proforma to capture health and social care costs as well as costs from a societal and patient perspective (such as employment). Measured at baseline, day 30, day 120.
9. Mortality. Obtained from hospital records, or through linkage with NHS central records, mortality is a binary outcome that defines whether a patient has died between day 0 (randomisation) until day 120.