Search

Background. Cardiovascular disease is a major cause of morbidity and mortality in kidney transplant recipients. Trial evidence to improve cardiovascular outcomes is limited by inconsistent reporting of outcomes, which may also lack patient-relevance. This study aimed to assess the range and consistency of cardiovascular outcomes reported by contemporary trials in kidney transplant recipients. Methods. A systematic review of all randomized controlled trials involving adult kidney transplant recipients that reported at least 1 cardiovascular outcome from January 2012 to December 2019 was performed, including Embase, MEDLINE, Cochrane, and ClinicalTrials.gov electronic databases. Trial characteristics were extracted and all levels of specification of the cardiovascular outcome measures reported were analyzed (the measure definition, metric‚ and method of aggregation). Measures assessing a similar aspect of cardiovascular disease were categorized into outcomes. Results. From 93 eligible trials involving 27 609 participants, 490 outcome measures were identified. The outcome measures were grouped into 38 outcomes. A cardiovascular composite was the most common outcome reported (40 trials, 43%) followed by cardiovascular mortality (42%) and acute coronary syndrome (31%). Cardiovascular composite was also the most heterogeneous outcome with 77 measures reported followed by cardiovascular mortality (n = 58) and inflammatory biomarkers (n = 51). The most common cardiovascular composite outcome components reported were major cardiovascular events (18 trials), stroke unspecified (11 trials), and myocardial infarction unspecified (10 trials). Conclusions. There is substantial heterogeneity in cardiovascular outcome reporting in kidney transplant trials.

Patients with kidney failure and early stages of chronic kidney disease often develop hyperphosphatemia, which is associated with negative outcomes. The reduction of phosphate levels is the established clinical practice. However, achieving and maintaining target phosphate levels is challenging, and the current methods of phosphate management lead to poor quality of life (QoL) in patients receiving dialysis, particularly because patients might not receive adequate education on phosphate control. Patients receiving dialysis are advised to maintain stringent dietary restrictions and might experience anxiety and depression due to the constant burden of dietary self-management. The lack of nutritional information on food labels makes adhering to dietary restrictions even more confusing and difficult. Phosphate binders are the only pharmacologic treatment currently indicated for hyperphosphatemia. However, phosphate binders have a limited binding capacity and are difficult to incorporate into patients’ daily routines. Because of the suboptimal efficacy of phosphate binders and the negative impact of dietary restrictions on patient QoL, novel therapies for more effective phosphate control are needed. New treatment options that control phosphate levels would enable patients to eat a more normal, healthy diet and potentially improve their QoL.

Rationale & Objective: Despite growing interest in individualizing care, routine dialysis processes, including the interdisciplinary plan of care, often fail to account for patient-identified priorities. To better align dialysis care with patient priorities and improve care planning experiences, we implemented a person-centered care plan program at a single clinic. We also sought to gain insight into key implementation considerations and areas for program improvement. Study Design: 6-month quality improvement project with research substudy. Setting & Participants: 49 hemodialysis patients and 14 care team members at a North Carolina dialysis clinic. Quality Improvement Activities: Implementation of My Dialysis Plan, a person-centered care plan program. Outcome(s): Participant perspectives and care plan meeting characteristics (quality improvement); pre- to postprogram change in patient-reported autonomy support, patient-centeredness of care, and dialysis care individualization (research). Analytical Approach: We used the Consolidated Framework for Implementation Research to guide implementation and evaluation. We conducted pre-, intra-, and post-project interviews with clinic stakeholders (patients, clinic personnel, and medical providers) to identify implementation barriers, facilitators, and perceptions. We compared pre- and post-project care plan meeting content and patient-reported outcome survey scores. Results: We conducted 54 care plans with 49 patients. Overall, care teams successfully used My Dialysis Plan to elicit and link patient priorities to actionable aspects of dialysis care. Participants identified interdisciplinary team commitment, accountability, and the structured yet flexible meeting approach as key implementation elements. Throughout the project, stakeholder input guided program modifications (eg, implementation practices and resources) to better meet clinic needs, but follow-up on care plan–identified action items remained challenging. Among the 28 substudy participants, there was no difference in pre- to post-project patient-reported outcome survey scores. Limitations: Single clinic implementation. Conclusions: My Dialysis Plan has the potential to enhance dialysis care individualization and care plan experiences. Evaluation of program impact on patient-reported and clinical outcomes is needed.