Table 1.

Lessons concerning choice and definition of composite end points

(1) Primary composite endpoints should include events resulting from pathophysiologic pathways highly likely to be influenced by the intervention.

(2A) Heart failure in patients receiving dialysis occurs frequently but is often misdiagnosed by nephrologists even when the definition includes manifestations of pulmonary edema. Sample size should be increased to account for misclassification.

(2B) Randomized clinical trials in CKD or ESRD that include an end point of heart failure should include focused education to ensure accurate identification of heart failure events.

(2C) A classification system of heart failure based on patient-reported dyspnea assessed pre- and post-ultrafiltration in conjunction with echocardiography may be useful (6) but requires validation.

(3) Selection bias associated with parathyroidectomy necessitated a more holistic approach to the definition of severe unremitting hyperparathyroidism.