Core Outcome Measures in Effectiveness Trials

Standardised Outcomes in Nephrology – Peritoneal Dialysis (SONG-PD): study protocol for establishing a core outcome set in peritoneal dialysis

General Information

Summary:
Background—Worldwide, approximately 11% of patients on dialysis receive peritoneal dialysis (PD). Whilst PD may offer more autonomy to patients compared with haemodialysis, 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 randomised 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 five phases in the SONG-PD project are: a systematic review to identify outcomes and outcome measures that have been reported in randomised 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 three-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 peritoneal dialysis trials.

Discussion—The establishment of 3–5 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.

Study protocol: https://www.ncbi.nlm.nih.gov/pubmed/28765167

Contributors:
Karine E. Manera1,2, Allison Tong1,2, Jonathan C. Craig1,2, Edwina A. Brown3, Gillian Brunier4, Jie Dong5, Tony Dunning6, Rajnish Mehrotra7, Sarala Naicker8, Roberto Pecoits-Filho9, Jeffrey Perl10, Angela Y. Wang11, Martin Wilkie12, Martin Howell1,2, Benedicte Sautenet1,2,13, Nicole Evangelidis1,2, Jenny I. Shen14, and David W. Johnson15,16,17 on behalf of the SONG-PD Investigators1

Further Study Information

Current Stage:
Ongoing
Date:
Funding source(s):

Health Area

Disease Category
Kidney disease

Disease Name
Chronic kidney disease

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Procedure

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Nominal group technique (NGT)
Systematic review

The SONG-PD process will follow the standard methods used in previous streams of the SONG Initiative, which were informed by the OMERACT framework that has been recognised by the World Health Organisation (WHO) as a valid approach for developing core outcomes. As the core outcomes are to be reported in all PD trials, identifying 3 to 5 core outcomes has been recommended based on feasibility. We will use the Core Outcome Set – Standard for Reporting (COS-STAR) to report all phases of the SONG-PD project. SONG-PD involves five phases: a systematic review, focus groups using nominal group technique, semi-structured key informant interviews, an international online Delphi survey, and a consensus workshop.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Pharmaceutical industry representatives
Policy makers
Researchers

Study Type

COS for clinical trials or clinical research

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