Standardized Outcomes in Nephrology-Peritoneal Dialysis (SONG-PD): Study Protocol for Establishing a Core Outcome Set...

Area of Science:

• Nephrology
• Clinical Trials
• Patient-Reported Outcomes

Background:

• Peritoneal dialysis (PD) is used by 11% of dialysis patients globally.
• Challenges in PD include patient burnout, technique failure, and peritonitis.
• Current PD trials may not measure outcomes most relevant to patients and clinicians.

Purpose of the Study:

• To establish a consensus-driven set of core outcomes for PD clinical trials.
• To ensure trial outcomes reflect the priorities of patients, caregivers, and health professionals.
• To improve the reliability and relevance of PD intervention research.

Main Methods:

• Systematic review of existing PD trial outcomes.
• Focus groups with patients and caregivers.
• Key informant interviews with healthcare professionals.
• International Delphi survey and consensus workshop.

Main Results:

• Identification and prioritization of key outcomes for PD trials.
• Development of a stakeholder-endorsed set of core outcome domains.
• Focus on outcomes of shared importance for decision-making.

Conclusions:

• A core set of 3-5 high-priority outcomes will be established for PD trials.
• Consistent reporting of these outcomes will enhance informed clinical decision-making.
• This standardization will facilitate reliable comparison of PD interventions.