SO046SCOPE AND CONSISTENCY OF OUTCOMES REPORTED IN RANDOMISED TRIALS CONDUCTED IN ADULTS ON HAEMODIALYSIS

Abstract

INTRODUCTION AND AIMS: Clinical trials are most informative for evidencebased decision‐making when they consistently measure and report outcomes of relevance to stakeholders. We aimed to assess the scope and consistency of outcomes reported in trials for haemodialysis. METHODS: Using all Cochrane systematic reviews of interventions published by the 29th of August 2016 and the trials published and registered in ClinicalTrial.gov since January 2011, we identified all the trials that have included adults on chronic haemodialysis and then analysed the frequency and characteristics of the outcome domains and measures reported. RESULTS: From the 362 included trials, we extracted and classified 10713 outcomes measures (median 21 per trial, interquartile range 10 to 39) into 81 different outcome domains, of which 42 (52%) were surrogate, 25 (31%) clinical and 14 (17%), patientreported. The number of outcomes measures reported significantly changed over time. The five most commonly reported domains were all surrogates: phosphate (125 [35%] trials), dialysis adequacy (120 [33]), anaemia (115 [32]), inflammatory markers (114 [31%]) and calcium (109 [30%]). Death, cardiovascular diseases and quality of life were reported very infrequently (73 [20%], 44 [12%] and 32 [9%], respectively). CONCLUSIONS: The outcomes reported in clinical trials involving adults on haemodialysis are focused on surrogate outcomes, rather than on clinical and patientcentred outcomes. There is also extreme multiplicity and heterogeneity at every level ‐ domain, measure, metric, and time point ‐ making estimates of comparative effectiveness of available interventions unreliable and no improvements over time are evident. (Figure presented).