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. 2017 Nov-Dec;37(6):639-647.
doi: 10.3747/pdi.2017.00022. Epub 2017 Aug 1.

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

Karine E Manera  1   2 , Allison Tong  3   2 , Jonathan C Craig  3   2 , Edwina A Brown  4 , Gillian Brunier  5 , Jie Dong  6 , Tony Dunning  7 , Rajnish Mehrotra  8 , Sarala Naicker  9 , Roberto Pecoits-Filho  10 , Jeffrey Perl  11 , Angela Y Wang  12 , Martin Wilkie  13 , Martin Howell  3   2 , Benedicte Sautenet  3   2   14 , Nicole Evangelidis  3   2 , Jenny I Shen  15 , David W Johnson  16   17   18 ; SONG-PD Investigators
Affiliations

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

Karine E Manera et al. Perit Dial Int. 2017 Nov-Dec.

Abstract

Background: Worldwide, approximately 11% of patients on dialysis receive peritoneal dialysis (PD). Whilst PD may offer more autonomy to patients compared with hemodialysis, patient and caregiver burnout, technique failure, and peritonitis remain major challenges to the success of PD. Improvements in care and outcomes are likely to be mediated by randomized trials of innovative therapies, but will be limited if the outcomes measured and reported are not important for patients and clinicians. The aim of the Standardised Outcomes in Nephrology-Peritoneal Dialysis (SONG-PD) study is to establish a set of core outcomes for trials in patients on PD based on the shared priorities of all stakeholders, so that outcomes of most relevance for decision-making can be evaluated, and that interventions can be compared reliably.

Methods: The 5 phases in the SONG-PD project are: a systematic review to identify outcomes and outcome measures that have been reported in randomized trials involving patients on PD; focus groups using nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choice of outcomes; semi-structured key informant interviews with health professionals; a 3-round international Delphi survey involving a multi-stakeholder panel; and a consensus workshop to review and endorse the proposed set of core outcome domains for PD trials.

Discussion: The establishment of 3 to 5 high-priority core outcomes, to be measured and reported consistently in all trials in PD, will enable patients and clinicians to make informed decisions about the relative effectiveness of interventions, based upon outcomes of common importance.

Keywords: Core outcome set; chronic kidney disease; clinical trials; dialysis; outcomes research; patient-centered outcomes; patient-reported outcomes; peritoneal dialysis.

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Conflict of interest statement

Disclosure: The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Conceptual schema of core outcome domains
Figure 2
Figure 2
SONG-PD process
See this image and copyright information in PMC

References

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