A Study to Inform the Design of a National Multicentre Randomised Controlled Trial to Evaluate If Reducing Serum Phosphate to Normal Levels Improves Clinical Outcomes including Mortality, Cardiovascular Events, Bone Pain, or Fracture in Patients on Dialysis

Table 5

Measuring trial endpoints.

Outcome measures	Assessment
Percentage of Greater Manchester kidney physicians agreeing to enter patients into a study which includes a “higher range” group	Survey of the nephrology consultants in the Greater Manchester area
Percentage of eligible invited patients willing to be randomised into a study which includes a “higher range” group	Log of all eligible patients in the Greater Manchester area to be maintained
Percentage of patients achieving consistent control of serum phosphate in each group over a 10-month maintenance period	This information will be obtained from the trial database
Drop-out rate from the study due to adverse events, kidney transplantation, intercurrent illness, and death; these numbers will inform the power calculation for the larger national study	This information will be obtained from the trial database
Pill burden per patient to control serum phosphate	The total number of phosphate binding medications needed in every patient to achieve the desired range of serum phosphates will be calculated
Adherence with therapy	BAASIS once every 4 weeks
Willingness of subjects to participate in Communicare patient support programme	The number of patients willing to use the package will be documented
Mean symptom score assessed by Pittsburgh Dialysis Symptoms Index	This will be done at the beginning, midway, and the end of the study
Incidence of major vascular events, defined as nonfatal myocardial infarction or any cardiac death, any stroke, or any arterial revascularisation excluding dialysis access procedures	This information will be captured on the CRF and transferred to the trial database