Implementing core outcomes in kidney disease: report of the Standardized Outcomes in Nephrology (SONG) implementation workshop

Abstract

There are an estimated 14,000 randomized trials published in chronic kidney disease. The most frequently reported outcomes are biochemical endpoints, rather than clinical and patient-reported outcomes including cardiovascular disease, mortality, and quality of life. While many trials have focused on optimizing kidney health, the heterogeneity and uncertain relevance of outcomes reported across trials may limit their policy and practice impact. The international Standardized Outcomes in Nephrology (SONG) Initiative was formed to identify core outcomes that are critically important to patients and health professionals, to be reported consistently across trials. We convened a SONG Implementation Workshop to discuss the implementation of core outcomes. Eighty-two patients/caregivers and health professionals participated in plenary and breakout discussions. In this report, we summarize the findings of the workshop in two main themes: socializing the concept of core outcomes, and demonstrating feasibility and usability. We outline implementation strategies and pathways to be established through partnership with stakeholders, which may bolster acceptance and reporting of core outcomes in trials, and encourage their use by end-users such as guideline producers and policymakers to help improve patient-important outcomes.

Patient-reported intra-dialytic symptoms and post-dialysis recovery times are influenced by psychological distress rather than dialysis prescription

“…Compared to previous studies in haemodialysis patients, our haemodiafiltration cohort generally reported fewer dialysis symptoms and quicker post-treatment recovery times [5,31]. However, in keeping with recent reports, we found that fatigue was the most commonly reported symptom by our haemodialysis patients [32]. The next most commonly reported dialysis-associated symptom was one of feeling the cold.…”

Evaluation of dialysis centres: values and criteria of the stakeholders

“…Mortality also has a differentiated weighting: lower for patients and higher for clinicians and managers. Despite these differences in assessment among the stakeholders, only recently has the need to include the patient's perspective in a routine and explicit way been emphasized [23][24][25][26]. PROMs are a priority for patients and other stakeholders, reflecting their preferences, and should be systematically considered in evaluation systems.…”

Strategies to improve vascular access outcomes in haemodialysis patients

“…The broad applicability of this outcome to all access types, the absolute necessity of a functioning vascular access to provide adequate dialysis, and the detrimental consequences of a failing access make this outcome a meaningful and suitable core outcome. A definition and metric for vascular access function is currently in development and will be piloted and validated in an international, multicentre study to ensure it is a reliable and feasible outcome measure to be used in research and routine clinical practice without adding undue burden to researchers and health professionals to ensure global implementation 1, 145,181 . Consistent reporting of a validated, feasible, robust and meaningful outcome measure for vascular access function in research and ultimately in quality improvement projects will help to inform clinical practice and decision making in a meaningful way.…”

“…Based on the contributions of 1,376 participants from 73 countries, the four core outcome domains included (1) vascular access, (2) fatigue, (3) cardiovascular disease, and (4) mortality 11,143,144 . For each of these core outcome domains, the most critically important outcome measure will be developed following a similar multi-step process including a systematic review, international survey, consensus workshop, pilot and validation study to ensure successful implementation 139,145 . This thesis will describe the process and outcomes of establishing a core outcome measure for vascular access.…”

“…In addition to demonstrating feasibility and robustness of the vascular access core outcome, a multipronged approach will be required to socialise the concept and need for core outcomes in will expedite the future uptake of core outcomes 134,145 . The consistent reporting of vascular access function in clinical trials will facilitate the discovery of effective interventions to improve vascular access outcomes.…”