Developing and establishing the content validity of a patient reported experience measure for the kidney transplant evaluation process

PROJECT SUMMARY/ABSTRACT Transplant is a valuable treatment option for many people with kidney failure, but in order to receive a kidney, patients must first be referred to a transplant center and complete a process of physical and psychosocial evaluation. Nephrologists and dialysis organizations are increasingly incentivized to refer greater numbers of patients with kidney failure to transplant centers in an effort to improve equitable access to this treatment. Such efforts can also be expected to increase the number and clinical complexity of patients engaging in the evaluation process. However, many patients will not ultimately receive a kidney and the evaluation process itself can be demanding, opaque, and lengthy and can take an emotional and psychosocial toll for patients and families. As more patients are drawn into this care process, multiple national stakeholder groups have emphasized the importance of minimizing burdens and improving patient experience. However, efforts to improve this patient experience are hampered by a lack of validated measures. In recent years, leading professional societies, regulators, and patient communities have called for the development of patient-reported outcome measures of the pre-transplant process. The aim of the proposed work is to develop and establish the content validity of a Kidney Transplant Evaluation Patient Reported Experience Measure (KTE-PREM). In Phase 1 (concept elicitation), we will perform a structured literature review, analyze existing qualitative interview transcripts, and conduct focus groups with patients who were referred to a transplant center, their family members, and clinicians who care for these patients (including primary nephrologists, social workers, and transplant team members). Patients will be recruited from Northwest Kidney Centers (a large non-profit dialysis organization based in Washington state which typically refers patients to three regional transplant centers) and the University of Washington. These sequential steps will result in a comprehensive set of concepts potentially relevant to a KTE-PREM. In Phase 2 (concept prioritization), we will identify items most relevant to patients to be included in a KTE-PREM by conducting a national survey among patients receiving care at two large non-profit dialysis organizations (Northwest Kidney Centers and Dialysis Clinic, Inc) who were referred to a kidney transplant center. In Phase 3 (instrument construction and refinement), we will design a draft KTE-PREM and iteratively refine the instrument through cognitive interviews with a local group of patients who were referred to a kidney transplant center. The proposed work directly extends from Dr. Butler’s recent NIH/NIDDK supported research (K23DK129777), which has identified a need and opportunities to improve person centricity of the kidney transplant evaluation process. Following development of the KTE-PREM, additional funding will be sought for validation. We anticipate that this validated instrument will have applications in clinical, research, and policy work intended to measure and improve patient experience in the kidney transplant evaluation.