SONG-PD
Research type
Research Study
Full title
Standardised Outcomes in Nephrology - Peritoneal Dialysis (SONG-PD): Study protocol for establishing a core outcome set in peritoneal dialysis
IRAS ID
232891
Contact name
Martin Wilkie
Contact email
Sponsor organisation
The University of Sydney
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Despite the increase in the number of randomised trials in nephrology, and more specifically in Peritoneal Dialysis (PD), there is an apparent lack of patient-centred outcomes reported in trials. Outcomes of value to PD patients, such as the ability to work or to travel, are generally not reported. Concerns about the “idolatry of the surrogate” have led to the growing recognition of the need to report patient-centred outcomes including mortality, functioning, symptoms, and other dimensions of quality of life. Incorporating patient values in research priority setting and study design not only improves patient-centred outcomes, but can optimise patient satisfaction and promote adherence to treatment.
Instead of reporting patient-centred outcomes, trials frequently report surrogate outcomes, such as biochemical markers. Surrogate outcomes are typically chosen based on feasibility, i.e. those that require less time, resources, and trial participants to evaluate treatment efficacy. This is problematic given that serum biomarkers are generally not well validated and may not translate into health and quality of life outcomes that are directly meaningful to patients.
A Delphi survey will be conducted to gain consensus on the 3 to 5 core outcome domains which are most important to stakeholders internationally. The survey will be conducted online and will involve three rounds of surveys completed by a panel of anonymous participants who have experience or expertise in PD.Individual participants will be able to provide feedback and contribute their perspectives on the results from each round to the group. This in turn will provide the opportunity for participants to revise their choices in response to the views of others. The Delphi is a validated technique which has been used across a variety of health disciplines to generate consensus on core outcomes for clinical trials.
REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/1630
Date of REC Opinion
21 Sep 2017
REC opinion
Favourable Opinion