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Abstract: TH-PO370

Developing Consensus-Based Outcome Domains for Trials in Peritoneal Dialysis: An International Delphi Survey

Session Information

Category: Dialysis

  • 703 Dialysis: Peritoneal Dialysis

Authors

  • Manera, Karine E., The University of Sydney, Sydney, New South Wales, Australia
  • Tong, Allison, The University of Sydney, Sydney, New South Wales, Australia
  • Craig, Jonathan C., The University of Sydney, Sydney, New South Wales, Australia
  • Johnson, David W., Princess Alexandra Hospital, Brisbane, Queensland, Australia

Group or Team Name

  • on behalf of the SONG-PD Steering Group
Background

Major inconsistencies in the reporting of outcomes, the omission of patient-reported outcomes, and frequent reporting of surrogate outcomes in trials impedes evidence-informed decision making by patients and their clinicians.

Methods

In an international online 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcomes using a 9-point Likert scale and provided comments. In rounds 2 and 3, participants re-rated the outcomes after reviewing the scores and comments of other respondents. For each outcome we calculated the mean, median, and proportion rating 7-9 (critically important).

Results

In total, 873 participants (207 [24%] patients/caregivers and 666 [76%] health professionals) from 68 countries completed round 1, and 530 (61%) completed round 3. The top outcomes based on a threshold (mean >8; median ≥8; proportion >85% in both groups) were PD-infection, membrane functioning, PD failure, cardiovascular disease, mortality, catheter complications, and ability to do usual activities. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes: blood pressure (mean difference of 0.4), fatigue (0.3), membrane functioning (0.3), impact on family/friends (0.1), peritoneal thickening [EPS] (0.1), and usual activities (0.1).

Conclusion

Clinical outcomes were highly prioritised by both stakeholder groups. Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. This process will inform a core outcome set to improve the consistency and relevance of outcomes reported in trials in peritoneal dialysis.