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. 2023 Aug 12;24:522. doi: 10.1186/s13063-023-07565-w

Table 3.

The schedule of enrolment, randomisation, assessments and follow-up

Procedure Screening Baseline 1 month 2 months 3 months 4 months 5 months 6 months 3 years
Review eligibility criteria X X
Written informed consent X
Demographic data and medical history X
Questionnaires: KDQoL, EQ-5D-5L, PSQI, SONG-HD, TTR X X X X
MoCA X X X
Baseline health economics questionnaire X
Randomisation X
Intradialytic urine collection and paired blood samples* X X
Serum beta-2 microglobulin* X X X X X X X
Resource use and expenditure questionnaire X X X
Routine clinical data including adherence, dialysis adequacy, blood pressure and monthly blood results X X X X X X X
Capture of routine clinical data and resource usage (UKRR, SRR, HES, ONS, ISD) X

*Blood samples drawn at the same time as routine clinical testing. Routinely collected data on all dialysis units