Establishing a Core Outcome Set for Peritoneal Dialysis: Report of the SONG-PD (Standardized Outcomes in Nephrology–Peritoneal Dialysis) Consensus Workshop

doi:10.1053/j.ajkd.2019.09.017

American Journal of Kidney Diseases

Volume 75, Issue 3, March 2020, Pages 404-412

https://doi.org/10.1053/j.ajkd.2019.09.017 Get rights and content

Outcomes reported in randomized controlled trials in peritoneal dialysis (PD) are diverse, are measured inconsistently, and may not be important to patients, families, and clinicians. The Standardized Outcomes in Nephrology–Peritoneal Dialysis (SONG-PD) initiative aims to establish a core outcome set for trials in PD based on the shared priorities of all stakeholders. We convened an international SONG-PD stakeholder consensus workshop in May 2018 in Vancouver, Canada. Nineteen patients/caregivers and 51 health professionals attended. Participants discussed core outcome domains and implementation in trials in PD. Four themes relating to the formation of core outcome domains were identified: life participation as a main goal of PD, impact of fatigue, empowerment for preparation and planning, and separation of contributing factors from core factors. Considerations for implementation were identified: standardizing patient-reported outcomes, requiring a validated and feasible measure, simplicity of binary outcomes, responsiveness to interventions, and using positive terminology. All stakeholders supported inclusion of PD-related infection, cardiovascular disease, mortality, technique survival, and life participation as the core outcome domains for PD.

Introduction

Peritoneal dialysis (PD) is a cost-effective dialysis modality that enables patients to have a greater degree of autonomy and freedom compared with hemodialysis.¹ However, major challenges to the uptake and longevity of PD remain, including technique failure, infection, catheter problems, and treatment burden.²^,³ Despite the increasing number of trials aiming to improve outcomes for patients receiving PD, the evidence for interventions to improve patient-important outcomes remains limited by the predominant use of surrogate end points that have not been validated and highly heterogeneous outcomes, many of which may not be relevant to patients.⁴^,⁵

Mortality and technique failure are reported in only 38% and 29% of trials, respectively.⁶ Outcomes related to quality of life, including flexibility with time, the ability to travel or work, and fatigue, are of high priority for patients receiving PD and their families.⁷ However, quality of life is reported in <15% of trials in PD, and fatigue, in <5% of trials.⁶ The absence of patient-important outcomes in trials⁸^,⁹ in nephrology more generally and other medical specialties is well recognized. Initiatives such as the Core Outcome Measures in Effectiveness Trials (COMET), Outcome Measures in Rheumatology (OMERACT), and Standardized Outcomes in Nephrology (SONG) have been launched to bring together patients, caregivers, and health professionals to identify critically important outcomes, to ensure that trials consistently report relevant and meaningful outcomes to better inform shared decision making.10, 11, 12, 13

The SONG-PD initiative commenced in 2016 and aims to develop a core outcome set to be reported in all trials in PD.⁷^,¹⁴^,¹⁵ A core outcome set is defined as an agreed minimum set of standardized outcomes to be measured and reported in all trials in a defined clinical population.¹⁶ Having identified a consensus-based prioritized list of outcome domains through an international online Delphi survey,¹⁵ a consensus workshop was convened for patients, caregivers, and health professionals to review and discuss the potential core outcome domains. The aim of this workshop report is to describe stakeholders’ perspectives and considerations on the core outcome set for PD and to establish the core outcome set to be used in all trials in PD.

Section snippets

Overview and Context

The SONG-PD consensus workshop was convened at the 17th Congress of the International Society for Peritoneal Dialysis (May 7, 2018) in Vancouver, Canada, to elicit stakeholder perspectives on the potential core outcome set for PD. The potential core outcomes were based on data from an international 3-round Delphi survey that was completed online by patients, caregivers, and health professionals with experience or expertise in PD. The Delphi survey included outcome domains reported in trials in

Overview

The discussion was summarized into themes relating to the identification of the core outcome domains and considerations for implementation, which are described in the following section. Selected quotations supporting each theme are provided in Box 1. Box 2 provides a summary of recommendations based on the workshop discussions. Figure 2 reveals the SONG-PD core outcome domains.

Reflecting Need for Flexibility and Freedom

The reasons why patients chose PD as their preferred treatment modality included the desire to have the flexibility and

Postworkshop Consultation

All participants received a draft workshop report and were asked to provide feedback within a 2-week time frame. The SONG-PD core outcome set (Fig 2) was also sent to all participants for review and comment and was uploaded on the SONG website for feedback and comment (https://songinitiative.org/projects/song-pd/). Feedback was integrated into the final report, and the findings from the workshop were used to establish the SONG-PD core outcome domains.

Discussion

Patients who participated in the workshop valued the flexibility of PD therapy and wanted to preserve and prolong technique survival and avoid transfer to hemodialysis, which were critical for consideration in identifying the core outcome domains. Fatigue was recognized as a potentially debilitating symptom that could impair life participation. Clinical outcomes (ie, membrane function and catheter complications) that did not necessarily lead to irreversible PD technique failure were not

Article Information

SONG-PD Consensus Workshop Investigators

Health Professionals: Adeera Levin^a; Adrian Liew^b; Alfonso Cueto Manzano^c; Ali Abu Alfa^d; Alicia Neu^e; Allison Tong^f; Amanda Baumgart^f; Amelie Bernier-Jean^f; Amy Kelly^f; Ana Figueiredo^g; Andrea Matus^h; Andrea Viecelliⁱ; Angela Ju^f; Angela Yee-Moon Wang^j; Anjali Saxena^k; Ankit Sharma^f; Annie-Claire Nadeau-Fredette^l; Armando Teixeira-Pinto^f; Asher Mendelson^m; Ayano Kellyⁿ; Bak Leong Goh^o; Benedicte Sautenet^p; Braden Manns^q; Brenda Hemmelgarn^q; Bruce Robinson^r; Camilla Hanson^f; Catherine Cheung^s;

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Patient-Centered Quality Measures for Dialysis Care: A Report of a Kidney Disease Outcomes Quality Initiative (KDOQI) Scientific Workshop Sponsored by the National Kidney Foundation
2024, American Journal of Kidney Diseases
Providing high-quality patient-centered care is the central mission of dialysis facilities. Assessing quality and patient-centeredness of dialysis care is necessary for continuous dialysis facility improvement. Based predominantly on readily measured items, current quality measures in dialysis care emphasize biochemical and utilization outcomes, with very few patient-reported items. Additionally, current metrics often do not account for patient preferences and may compromise patient-centered care by limiting the ability of providers to individualize care targets, such as dialysis adequacy, based on patient priorities rather than a fixed numerical target. Developing, implementing, and maintaining a quality program using readily quantifiable data while also allowing for individualization of care targets that emphasize the goals of patients and their care partners provided the motivation for a September 2022 Kidney Disease Outcomes Quality Initiative (KDOQI) Workshop on Patient-Centered Quality Measures for Dialysis Care. Workshop participants focused on 4 questions: (1) What are the outcomes that are most important to patients and their care partners? (2) How can social determinants of health be accounted for in quality measures? (3) How can individualized care be effectively addressed in population-level quality programs? (4) What are the optimal means for collecting valid and robust patient-reported outcome data? Workshop participants identified numerous gaps within the current quality system and favored a conceptually broader, but not larger, quality system that stresses highly meaningful and adaptive measures that incorporate patient-centered principles, individual life goals, and social risk factors. Workshop participants also identified a need for new, low-burden tools to assess patient goals and priorities.
Impact of Remote Monitoring on Standardized Outcomes in Nephrology-Peritoneal Dialysis
2024, Kidney International Reports
This study aimed to evaluate the association between the use of remote patient monitoring (RPM) in patients on automated peritoneal dialysis (APD) and the Standardized Outcomes in Nephrology in peritoneal dialysis (SONG-PD) clinical outcomes.
A prospective and multicenter cohort study was conducted on patients with advanced chronic kidney disease on APD, recruited at 16 Spanish Hospitals, between June 1 and December 31, 2021. Patients were divided into 2 cohorts, namely patients on APD with RPM (APD-RPM) and patients on APD without RPM. The primary endpoints were the standardized outcomes of the SONG-PD clinical outcomes: PD-associated infection, cardiovascular disease (CVD), mortality rate, technique survival, and life participation (assessed as health-related quality of life [QoL]). Propensity score matching (PSM) was used to evaluate the association of RPM exposure with the clinical outcomes.
A total of 232 patients were included, 176 (75.9%) in the APD-RPM group and 56 (24.1%) in the APD-without-RPM group. The mean patient follow-up time was significantly longer in the APD-RPM group than in the APD-without-RPM group (10.4 ± 2.8 vs. 9.4 ± 3.1 months, respectively; P = 0.02). In the overall study sample, the APD-RPM group was associated with a lower mortality rate (hazard ratio [HR]: 0.08; 95% confidence interval [CI]: 0.01 to 0.69; P = 0.020) and greater technique survival rate (HR: 0.25; 95% CI: 0.11 to 0.59; P = 0.001). After PSM, APD-RPM continued to be associated with better technique survival (HR: 0.23; 95% CI: 0.06 to 0.83; P = 0.024).
The use of RPM programs in patients on APD was associated with better survival of the technique and lower mortality rates. However, after PSM, only technique survival was significant.
Characteristics and Frequency of Physical Activity and Exercise-Related Side Effects in People Receiving Peritoneal Dialysis
2024, Journal of Renal Nutrition
People receiving peritoneal dialysis may receive health benefits from physical activity or exercise. However, on-going uncertainty and fear regarding safety may result in this population missing out on the health benefits of participation. The aim of this study was to explore the characteristics and frequency of physical activity and/or exercise-related side effects (e.g., symptoms such as pain or shortness of breath) and negative health events (e.g., stroke or hyper/hypoglycemia) experienced by people receiving peritoneal dialysis.
An international online survey involving adults receiving peritoneal dialysis was conducted with questions related to nature, occurrence, and impact of side effects and/or negative health events experienced during or soon after participation in physical activity or exercise.
Fifty-two people completed the survey reporting 151 side effects that were related to physical activity and exercise and 67 that were possibly related. Fatigue (58% of respondents), muscle/joint soreness or pain (54%), and dizziness (43%) were the most frequently reported side-effect types. The majority occurred occasionally (58% of all side effects), if not rarely (24%) and participation in on-going physical activity or exercise was typically prevented only occasionally (39%) or not at all (31%). Side effects were mainly self-managed (54% of all side effects) or did not require treatment (19%) and had low (38%) or no effect (30%) on ability to do daily activities.
People receiving peritoneal dialysis generally experience side effects that can be considered a normal response to physical activity or exercise engagement. Furthermore, the risk of serious or peritoneal dialysis-specific side effects as a result of physical activity or exercise appears to be low. The results add to the emerging evidence suggesting physical activity and exercise appear to be safe for people receiving peritoneal dialysis.
Outcomes of Integrated Home Dialysis Care: Results From the Canadian Organ Replacement Register
2024, American Journal of Kidney Diseases
The integrated home dialysis model proposes the initiation of kidney replacement therapy (KRT) with peritoneal dialysis (PD) and a timely transition to home hemodialysis (HHD) after PD ends. We compared the outcomes of patients transitioning from PD to HHD with those initiating KRT with HHD.
Observational analysis of the Canadian Organ Replacement Register (CORR).
All patients who initiated PD or HHD within the first 90 days of KRT between 2005 and 2018.
Patients transitioning from PD to HHD (PD + HHD group) versus patients initiating KRT with HHD (HHD group).
(1) A composite of all-cause mortality and modality transfer (to in-center hemodialysis or PD for 90 days) and (2) all hospitalizations (considered as recurrent events).
A propensity score analysis for which PD + HHD patients were matched 1:1 to (1) incident HHD patients (“incident-match” analysis) or (2) HHD patients with a KRT vintage at least equivalent to the vintage of PD + HHD patients at the transition time (“vintage-matched” analysis). Cause-specific hazards models (composite outcome) and shared frailty models (hospitalization) were used to compare groups.
Among 63,327 individuals in the CORR, 163 PD + HHD patients (median of 1.9 years in PD) and 711 HHD patients were identified. In the incident-match analysis, compared to the HHD patients, the PD + HHD group had a similar risk of the composite outcome (HR, 0.88 [95% CI, 0.58-1.32]) and hospitalizations (HR, 1.04 [95% CI, 0.76-1.41]). In the vintage-match analysis, PD + HHD patients had a lower hazard for the composite outcome (HR, 0.61 [95% CI, 0.40-0.94]) but a similar hospitalization risk (HR, 0.85 [95% CI, 0.59-1.24]).
Risk of survivor bias in the PD + HHD cohort and residual confounding.
Controlling for KRT vintage, the patients transitioning from PD to HHD had better clinical outcomes than the incident HHD patients. These data support the use of integrated home dialysis for patients initiating home-based KRT.
The integrated home dialysis model proposes the initiation of dialysis with peritoneal dialysis (PD) and subsequent transition to home hemodialysis (HHD) once PD is no longer feasible. It allows patients to benefit from initial lifestyle advantages of PD and to continue home-based treatments after its termination. However, some patients may prefer to initiate dialysis with HHD from the outset. In this study, we compared the long-term clinical outcomes of both approaches using a large Canadian dialysis register. We found that both options led to a similar risk of hospitalization. In contrast, the PD-to-HHD model led to improved survival when controlling for the duration of kidney failure.
Catheter Event Rates in Medical Compared to Surgical Peritoneal Dialysis Catheter Insertion
2023, Kidney International Reports
How patient, center, and insertion technique factors interact needs to be understood when designing peritoneal dialysis (PD) catheter insertion pathways.
We undertook a prospective cohort study in 44 UK centers enrolling participants planned for first catheter insertion. Sequences of regressions were used to describe the associations linking patient and dialysis unit-level characteristics with catheter insertion technique and their impact on the occurrence of catheter-related events in the first year (catheter-related infection, hospitalization, and removal). Factors associated with catheter events were incorporated into a multistate model comparing the rates of catheter events between medical and surgical insertion alongside treatment modality transitions and mortality.
Of 784 first catheter insertions, 466 (59%) had a catheter event in the first year and 61.2% of transitions onto hemodialysis (HD) were immediately preceded by a catheter event. Catheter malfunction was less but infection was more common with surgical compared with medical insertions. Participants at centers with fewer late presenters and more new dialysis patients starting PD, had a lower probability of a catheter event. Adjusting for these factors, the hazard ratio for a catheter event following insertion (medical vs. surgical) was 0.70 (95% confidence interval [CI] 0.43 to 1.13), and once established on PD 0.77 (0.62 to 0.96).
Offering both medical and surgical techniques is associated with lower catheter event rates and keeps people on PD for longer.
Nutrition in Peritoneal Dialysis
2023, Advances in Kidney Disease and Health
The use of peritoneal dialysis (PD) has been associated with improved quality of life, cost-effectiveness, and better outcomes for patients with kidney failure. However, many patients utilizing PD for replacement therapy face numerous nutritional hurdles. As the use of PD continues to increase worldwide, malnutrition has become an increasingly recognized concern for patients undergoing PD. The nephrology community needs to recognize and treat malnutrition to promote optimal nutritional states for our patients. In this review, we discuss several factors that contribute to malnutrition and protein-energy wasting and explore the benefits and limitations of nutritional parameters used to assess protein-calorie malnutrition. We also emphasize updated guidelines on daily caloric, protein, and micronutrient recommendations, as well as their effects on electrolyte homeostasis.

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: Complete author and article information (including a list of the SONG-PD Workshop Investigators) provided before references.

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Special ReportEstablishing a Core Outcome Set for Peritoneal Dialysis: Report of the SONG-PD (Standardized Outcomes in Nephrology–Peritoneal Dialysis) Consensus Workshop

Introduction

Section snippets

Overview and Context

Overview

Reflecting Need for Flexibility and Freedom

Postworkshop Consultation

Discussion

Article Information

SONG-PD Consensus Workshop Investigators

Kidney Int

Kidney Int

J Clin Epidemiol

Kidney Int

Am J Kidney Dis

Am J Kidney Dis

Am J Kidney Dis

Kidney Int

Evaluating the benefits of home-based peritoneal dialysis

Int J Nephrol Renovasc Dis

Peritoneal dialysis drop-out: causes and prevention strategies

Int J Nephrol

Surrogate outcomes in clinical trials: a cautionary tale

JAMA Intern Med

Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis [abstract]

J Am Soc Nephrol

Special Report
Establishing a Core Outcome Set for Peritoneal Dialysis: Report of the SONG-PD (Standardized Outcomes in Nephrology–Peritoneal Dialysis) Consensus Workshop