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Table 3 Summary of follow-up data collection

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

 

Data items

Source

Routine laboratory data

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

UKRR

Cardiovascular and infection hospital admission data

Cardiovascular: nonspecific chest pain (102); congestive heart failure, non-hypertensive (108); coronary atherosclerosis (101); other circulatory diseases (117); acute myocardial infarction (100); peripheral and visceral atherosclerosis (114); chronic ulcer of skin (199); Gangrene (248); aortic, peripheral and visceral arterial disease (115); transient cerebral ischemia (112); cardiac arrest and ventricular fibrillation (107); pulmonary heart disease (103); other and ill-defined cerebrovascular disease (111); acute cerebrovascular disease (109)

Infection: pneumonia (122); septicemia (except in labour) (2); pleurisy, pneumothorax, pulmonary collapse (130); aortic and peripheral arterial emboli (116); tuberculosis (1); mycoses (4); HIV infection (5); encephalitis (77); meningitis (76); shock (249); skin and subcutaneous tissue infection (197); fever of unknown origin (246); infective arthritis and osteomyelitis (201); bacterial infection, unspecified site (3); other inflammatory conditions of the skin (198); other infections, including parasitic (8); influenza (123); urinary tract infections (159); genitourinary symptoms and ill-defined conditions (163)

Hospital Statistics (HES, PEDW, ISD),

Mortality data

Non-cancer mortality (i.e. all causes of death excluding chapter II causes in ICD-10)

NHS Spine tracing, UKRR, Hospital Statistics, Civil Registration

Patient-reported outcomes

EQ-5D-5L, DSI and time to recovery (following dialysis) [31]

Patient questionnaire administered 6 monthly

RRT use

Frequency, machine, dialyser, dialysis times and consumables used

Annual census (extracted from the renal IT system)

Other hospital admissions

Day case and inpatient hospital admissions (including surgical procedures performed)

Hospital Statistics (HES, PEDW, ISD)

Patient-reported healthcare use

Nursing home/residential home days/hospice days, and primary care, community services and medication usage in the last 6 months

Patient questionnaire administered 6 monthly

Blood stream infections

Methicillin-resistant Staphylococcus aureus, methicillin-sensitive Staphylococcus aureus, Clostridium difficile, and Escherichia coli, as the report by mandate to PHE/the UKHSA

Reported to PHE/UKHSA and shared with UKRR

  1. Numbers in parentheses following diagnoses refer to the Healthcare Cost and Utilisation Project Clinical Classification System for mapping diagnoses onto ICD-10 www.hcup-us.ahrq.gov. Abbreviations: HES Hospital Episode Statistics, ICD International Classification of Diseases, ISD Information Services Division, PEDW Patient Episode Database for Wales, PHE Public Health England, RRT Renal Replacement Therapy, UKHSA UK Health Security Agency, UKRR UK Renal Registry