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

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.

Meaning of empowerment in peritoneal dialysis: focus groups with patients and caregivers.

BACKGROUND: While peritoneal dialysis (PD) can offer patients more independence and flexibility compared with in-center hemodialysis, managing the ongoing and technically demanding regimen can impose a burden on patients and caregivers. Patient empowerment can strengthen capacity for self-management and improve treatment outcomes. We aimed to describe patients' and caregivers' perspectives on the meaning and role of patient empowerment in PD. METHODS: Adult patients receiving PD (n = 81) and their caregivers (n = 45), purposively sampled from nine dialysis units in Australia, Hong Kong and the USA, participated in 14 focus groups. Transcripts were thematically analyzed. RESULTS: We identified six themes: lacking clarity for self-management (limited understanding of rationale behind necessary restrictions, muddled by conflicting information); PD regimen restricting flexibility and freedom (burden in budgeting time, confined to be close to home); strength with supportive relationships (gaining reassurance with practical assistance, comforted by considerate health professionals, supported by family and friends); defying constraints (reclaiming the day, undeterred by treatment, refusing to be defined by illness); regaining lost vitality (enabling physical functioning, restoring energy for life participation); and personal growth through adjustment (building resilience and enabling positive outlook, accepting the dialysis regimen). CONCLUSIONS: Understanding the rationale behind lifestyle restrictions, practical assistance and family support in managing PD promoted patient empowerment, whereas being constrained in time and capacity for life participation outside the home undermined it. Education, counseling and strategies to minimize the disruption and burden of PD may enhance satisfaction and outcomes in patients requiring PD.

An international Delphi survey helped develop consensus-based core outcome domains for trials in peritoneal dialysis.

Shared decision-making about clinical care options in end-stage kidney disease is limited by inconsistencies in the reporting of outcomes and the omission of patient-important outcomes in trials. Here we generated a consensus-based prioritized list of outcomes to be reported during trials in peritoneal dialysis (PD). In an international, online, three-round Delphi survey, patients/caregivers and health professionals rated the importance of outcomes using a 9-point Likert scale (with 7-9 indicating critical importance) and provided comments. Using a Best-Worst Scale (BWS), the relative importance of outcomes was estimated. Comments were analyzed thematically. In total, 873 participants (207 patients/caregivers and 666 health professionals) from 68 countries completed round one, 629 completed round two and 530 completed round three. The top outcomes were PD-related infection, membrane function, peritoneal dialysis failure, cardiovascular disease, death, catheter complications, and the ability to do usual activities. Compared with health professionals, patients/caregivers gave higher priority to six outcomes: blood pressure (mean difference, 0.4), fatigue (0.3), membrane function (0.3), impact on family/friends (0.1), peritoneal thickening (0.1) and usual activities (0.1). Four themes were identified that underpinned the reasons for ratings: contributing to treatment longevity, preserving quality of life, escalating morbidity, and irrelevant and futile information and treatment. Patients/caregivers and health professionals gave highest priority to clinical outcomes. In contrast to health professionals, patients/caregivers gave higher priority to lifestyle-related outcomes including the impact on family/friends and usual activities. Thus, prioritization will inform a core outcome set to improve the consistency and relevance of outcomes for trials in PD.

Nursing management of catheter-related non-infectious complications of PD: Your questions answered.

A review from the last seven years (August 2016-July 2023) of questions posted to the International Society for Peritoneal Dialysis (ISPD) website "Questions about PD" by nurses and physicians from around the world revealed that 19 of the questions were associated with optimal approaches for preventing, assessing, and managing issues related to PD catheter non-infectious complications. Our review focused on responses to these questions whereby existing best practice recommendations were considered, if available, relevant literature was cited and differences in international practices discussed. We combined similar questions, revised both the original questions and responses for clarity, as well as updated the references to these questions. PD catheter non-infectious complications can often be prevented or, with early detection, the potential severity of the complication can be minimized. We suggest that the PD nurse is key to educating the patient on PD about PD catheter non-infectious complications, promptly recognize a specific complication and bring that complication to the attention of the Home Dialysis Team. The questions posted to the ISPD website highlight the need for more education and resources for PD nurses worldwide on the important topic of non-infectious complications related to PD catheters, thereby enabling us to prevent such complications as PD catheter malfunction, peri-catheter leakage and infusion or drain pain, as well as recognize and resolve these issues promptly when they do arise, thus allowing patients to extend their time on PD therapy and enhance their quality of life whilst on PD.

PD effluent specimen collection: Your questions answered.

When a patient on peritoneal dialysis (PD) presents with suspected PD-related peritonitis (e.g. cloudy PD fluid and abdominal pain), one of the most important initial aspects of management is for the nephrology nurse/home dialysis nurse to collect PD effluent specimens for white blood cells count, Gram stain, culture and sensitivity for inspection and to send for laboratory testing before antibiotics are started. A review by seven members of the International Society for Peritoneal Dialysis (ISPD) Nursing Committee of all 133 questions posted to the ISPD website 'Questions about PD' over the last 4 years (January 2018-December 2021), revealed 97 posted by nephrology nurses from around the world. Of these 97 questions, 10 were noted to be related to best practices for PD effluent specimen collection. For our review, we focused on these 10 questions along with their responses by the members of the ISPD 'Ask The Experts Team', whereby existing best practice recommendations were considered, if available, relevant literature was cited and differences in international practice discussed. We revised the original responses for clarity and updated the references. We found that these 10 questions were quite varied but could be organised into four categories: how to collect PD effluent safely; how to proceed with PD effluent collection; how to collect PD effluent for assessment; and how to proceed with follow-up PD effluent collection after intraperitoneal antibiotics have been started. In general, we found that there was limited evidence in the PD literature to answer several of these 10 questions posted to the ISPD website 'Questions about PD' by nephrology nurses from around the world on this important clinical topic of best practices for PD effluent specimen collection. Some of these questions were also not addressed in the latest ISPD Peritonitis Guidelines. Moreover, when polling members of our ISPD Nursing Committee we found when answering a few of these questions, nursing practice varied within and among countries. We encourage PD nurses to conduct their own research on this important topic, focusing on areas where research evidence is lacking.

Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis.

BACKGROUND: Randomized trials can provide evidence to inform decision-making but this may be limited if the outcomes of importance to patients and clinicians are omitted or reported inconsistently. We aimed to assess the scope and heterogeneity of outcomes reported in trials in peritoneal dialysis (PD). METHODS: We searched the Cochrane Kidney and Transplant Specialized Register for randomized trials in PD. We extracted all reported outcome domains and measurements and analyzed their frequency and characteristics. RESULTS: From 128 reports of 120 included trials, 80 different outcome domains were reported. Overall, 39 (49%) domains were surrogate, 23 (29%) patient-reported and 18 (22%) clinical. The five most commonly reported domains were PD-related infection [59 (49%) trials], dialysis solute clearance [51 (42%)], kidney function [45 (38%)], protein metabolism [44 (37%)] and inflammatory markers/oxidative stress [42 (35%)]. Quality of life was reported infrequently (4% of trials). Only 14 (12%) trials included a patient-reported outcome as a primary outcome. The median number of outcome measures (defined as a different measurement, aggregation and metric) was 22 (interquartile range 13-37) per trial. PD-related infection was the most frequently reported clinical outcome as well as the most frequently stated primary outcome. A total of 383 different measures for infection were used, with 66 used more than once. CONCLUSIONS: Trials in PD include important clinical outcomes such as infection, but these are measured and reported inconsistently. Patient-reported outcomes are infrequently reported and nearly half of the domains were surrogate. Standardized outcomes for PD trials are required to improve efficiency and relevance.

"Can I go to Glasgow?" Learnings from patient involvement at the 17th Congress of the International Society for Peritoneal Dialysis (ISPD).

BACKGROUND: Recognition of the discrepancy between the research priorities of patients and health professionals has prompted efforts to involve patients as active contributors in research activities, including scientific conferences. However, there is limited evidence about the experience, challenges, and impacts of patient involvement to inform best practice. This study aims to describe patient and health professional perspectives on patient involvement at the Congress of the International Society for Peritoneal Dialysis (ISPD). METHODS: Semi-structured interviews were conducted with 14 patients/caregivers and 15 health professionals from six countries who attended ISPD. Interviews were recorded and transcribed verbatim, and transcripts were analyzed thematically. RESULTS: We identified four themes: protecting and enhancing scientific learning (grounding science in stories, sharing and inspiring new perspectives, distilling the key messages of research presentations, striking a balance between accommodating patients and presenting the science); democratizing access to research (redistributing power, challenging the traditional ownership of knowledge, cultivating self-management through demystifying research); inadequate support for patient/caregiver delegates (lacking purposeful inclusion, challenges in interpreting research findings, soliciting medical advice, difficulty negotiating venue and program, limited financial assistance in attending); and amplifying impact beyond the room (sparking innovation in practice, giving patients and families hope for the future). CONCLUSIONS: Patient involvement at the ISPD Congress clarified the applicability of research to patient care and self-management, democratized science, and strengthened the potential impact of research. More structured support for patients to help them purposefully articulate their experience in relation to session objectives may enhance their contribution and their own learning experience.

Patient and Caregiver Priorities for Outcomes in Peritoneal Dialysis: Multinational Nominal Group Technique Study.

BACKGROUND AND OBJECTIVES: The absence of accepted patient-centered outcomes in research can limit shared decision-making in peritoneal dialysis (PD), particularly because PD-related treatments can be associated with mortality, technique failure, and complications that can impair quality of life. We aimed to identify patient and caregiver priorities for outcomes in PD, and to describe the reasons for their choices. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Patients on PD and their caregivers were purposively sampled from nine dialysis units across Australia, the United States, and Hong Kong. Using nominal group technique, participants identified and ranked outcomes, and discussed the reasons for their choices. An importance score (scale 0-1) was calculated for each outcome. Qualitative data were analyzed thematically. RESULTS: Across 14 groups, 126 participants (81 patients, 45 caregivers), aged 18-84 (mean 54, SD 15) years, identified 56 outcomes. The ten highest ranked outcomes were PD infection (importance score, 0.27), mortality (0.25), fatigue (0.25), flexibility with time (0.18), BP (0.17), PD failure (0.16), ability to travel (0.15), sleep (0.14), ability to work (0.14), and effect on family (0.12). Mortality was ranked first in Australia, second in Hong Kong, and 15th in the United States. The five themes were serious and cascading consequences on health, current and impending relevance, maintaining role and social functioning, requiring constant vigilance, and beyond control and responsibility. CONCLUSIONS: For patients on PD and their caregivers, PD-related infection, mortality, and fatigue were of highest priority, and were focused on health, maintaining lifestyle, and self-management. Reporting these patient-centered outcomes may enhance the relevance of research to inform shared decision-making.

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

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.

Meeting the guidelines for end-of-life care.

The number of patients initiating dialysis in most countries continues to increase, with the greatest increase being in the oldest age group. Clinical practice guidelines have been developed to help the nephrology team with end-of-life carefor patients on dialysis. The aim of the project reported here was to assess if we were meeting the guidelines. We conducted a retrospective cohort study of all patients 80 years of age and older who had started dialysis at our center Our cohort included 105 patients (50% men; median age: 84.5 years; age range: 80-95 years), of whom 55% were on hemodialysis and 45% were on peritoneal dialysis (PD). Overall life expectancy was 2.1 years. Among the 59 patients who died while still part of our program, 92% had a do not resuscitate order in place, and 46% had withdrawn from dialysis. Palliative care was consulted in 46% of cases. Dyspnea and pain were the two most common symptoms in the last 24 hours of life. Of these 59 patients, 71% died in hospital. Only 6 patients died at home, all of these being on home PD. End-of-life care for this elderly cohort of dialysis patients could be improved on several measures to meet clinical practice guidelines, especially with greater access to palliative care units and community palliative care programs.

A Syllabus for Teaching Peritoneal Dialysis to Patients and Caregivers.

Being aware of controversies and lack of evidence in peritoneal dialysis (PD) training, the Nursing Liaison Committee of the International Society for Peritoneal Dialysis (ISPD) has undertaken a review of PD training programs around the world in order to develop a syllabus for PD training. This syllabus has been developed to help PD nurses train patients and caregivers based on a consensus of training program reviews, utilizing current theories and principles of adult education. It is designed as a 5-day program of about 3 hours per day, but both duration and content may be adjusted based on the learner. After completion of our proposed PD training syllabus, the PD nurse will have provided education to a patient and/or caregiver such that the patient/caregiver has the required knowledge, skills and abilities to perform PD at home safely and effectively. The course may also be modified to move some topics to additional training times in the early weeks after the initial sessions. Extra time may be needed to introduce other concepts, such as the renal diet or healthy lifestyle, or to arrange meetings with other healthcare professionals. The syllabus includes a checklist for PD patient assessment and another for PD training. Further research will be needed to evaluate the effect of training using this syllabus, based on patient and nurse satisfaction as well as on infection rates and longevity of PD as a treatment.

ISPD Cardiovascular and Metabolic Guidelines in Adult Peritoneal Dialysis Patients Part I - Assessment and Management of Various Cardiovascular Risk Factors.

Cardiovascular disease contributes significantly to the adverse clinical outcomes of peritoneal dialysis (PD) patients. Numerous cardiovascular risk factors play important roles in the development of various cardiovascular complications. Of these, loss of residual renal function is regarded as one of the key cardiovascular risk factors and is associated with an increased mortality and cardiovascular death. It is also recognized that PD solutions may incur significant adverse metabolic effects in PD patients. The International Society for Peritoneal Dialysis (ISPD) commissioned a global workgroup in 2012 to formulate a series of recommendations regarding lifestyle modification, assessment and management of various cardiovascular risk factors, as well as management of the various cardiovascular complications including coronary artery disease, heart failure, arrhythmia (specifically atrial fibrillation), cerebrovascular disease, peripheral arterial disease and sudden cardiac death, to be published in 2 guideline documents. This publication forms the first part of the guideline documents and includes recommendations on assessment and management of various cardiovascular risk factors. The documents are intended to serve as a global clinical practice guideline for clinicians who look after PD patients. The ISPD workgroup also identifies areas where evidence is lacking and further research is needed.

ISPD Cardiovascular and Metabolic Guidelines in Adult Peritoneal Dialysis Patients Part II - Management of Various Cardiovascular Complications.

Cardiovascular mortality has remained high in patients on peritoneal dialysis (PD) due to the high prevalence of various cardiovascular complications including coronary artery disease, left ventricular hypertrophy and dysfunction, heart failure, arrhythmia (especially atrial fibrillation), cerebrovascular disease, and peripheral arterial disease. In addition, nearly a quarter of PD patients develop sudden cardiac death as the terminal life event. Thus, it is essential to identify effective treatment that may lower cardiovascular mortality and improve survival of PD patients. The International Society for Peritoneal Dialysis (ISPD) commissioned a global workgroup in 2012 to formulate a series of recommendation statements regarding lifestyle modification, assessment and management of various cardiovascular risk factors, and management of the various cardiovascular complications to be published in 2 guideline documents. This publication forms the second part of the guideline documents and includes recommendation statements on the management of various cardiovascular complications in adult chronic PD patients. The documents are intended to serve as a global clinical practice guideline for clinicians who look after PD patients. We also define areas where evidence is clearly deficient and make suggestions for future research in each specific area.