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Table 1 Assessments and follow-up

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

Procedures

Data

Screening

Baseline

Treatment phase

Event based

 

Face-to-face visit 1

Follow-up (min = 32 month, max = 91 months)

No visits

Linkage

Patient questionnaire (6 monthly)

Eligibility assessment

 

√

    

Informed consent

  

√

   

Randomisation

  

√

   

Demographics

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

 

√

   

Clinical (1)

Primary renal disease, date first seen by a nephrologist, co-morbidities, dietary restrictions, 24-h urine volume

 

√

   

Clinical (2)

RRT treatment history, prescribed medication (including erythropoiesis-stimulating agents and phosphate binders)

 

√

√

  

Physical assessment (1)

Height, heart rate

 

√

   

Physical assessment (2)

Weight, systolic and diastolic blood pressure

 

√

√

  

Resource use (1)

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

 

√

√

  

Resource use (2)

Nursing home/residential home days/hospice days, other hospital out-patient services and primary care and community services in the last 6 months

 

√

 

√

 

Laboratory tests

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)

 

√

√

  

Patient reported

EQ-5D-5L and DSI and time to recovery [31]

 

√

 

√

 

SAE reporting

     

√