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Table 2 Summary of baseline data collection for the randomised controlled trial

From: The high-volume haemodiafiltration vs high-flux haemodialysis registry trial (H4RT): a multi-centre, unblinded, randomised, parallel-group, superiority study to compare the effectiveness and cost-effectiveness of high-volume haemodiafiltration and high-flux haemodialysis in people with kidney failure on maintenance dialysis using linkage to routine healthcare databases for outcomes

Demographics/social

Age, sex, ethnicity, marital status, education level, smoking history

Clinical

Primary renal disease, date first seen by a nephrologist, renal replacement therapy history, co-morbidities, prescribed medication (including erythropoiesis-stimulating agents and phosphate binders), 24-h urine volume (within the 6 weeks preceding randomisation)

Resource use

Day case and inpatient hospital admissions (including surgical procedures), nursing home/residential home days/hospice days, other hospital out-patient services, and primary care and community services in the last 6 months

Laboratory

Creatinine, urea, Kt/V, urea reduction ratio, albumin, haemoglobin, haematocrit, mean corpuscular volume, sodium, potassium, bicarbonate, corrected calcium, phosphate, C-reactive protein, intact parathyroid hormone, total cholesterol (from the date of the study visit or the closest date prior to the study visit)

Physical assessment

Height, weight, blood pressure, heart rate

Patient reported

EQ-5D-5L, Dialysis Symptom Index and time to recovery [31]

  1. Follow-up will continue for a minimum of 32 months and a maximum of 91 months. It will be undertaken through a combination of 6-monthly patient questionnaires and by linkage to routine healthcare databases — Hospital Episode Statistics, Civil Registration, Public Health England (PHE) to September 2021 and UK Health Security Agency (UKHSA) from October 2021, and the UKRR in England, and the equivalent databases in Scotland and Wales, as necessary (Table 3). Only data that are collected as part of routine care will be collected. Paper and electronic (web portal) options will be offered to patients for patient questionnaire completion.