Integrating PROMs in Routine Dialysis Care

High symptom burden and poor quality of life affect the majority of the half million people treated with maintenance hemodialysis in the United States. Individuals receiving hemodialysis report anywhere from six to 20 symptoms, with fatigue, poor sleep, depressed mood, and muscle cramping being some of the most distressing symptoms (1). Despite the high prevalence of symptoms and their importance to patients, clinicians often underappreciate and undertreat symptoms (2). One potential strategy to close this communication gap and improve symptoms and other patient-prioritized outcomes is the routine administration of patient-reported outcome measures (PROMs)—tools used to collect the status of patients' health conditions from the patients themselves without interpretation of the patient response by anyone else (3). Although federal programs mandate the use of health-related quality of life and experience of care PROMs in the dialysis setting, the effect of routine PROM administration on patient outcomes in the dialysis population is unknown. Among individuals with cancer, regular PROM administration improves patient-reported outcomes, including symptoms, and decreases hospitalizations (4,5). More meaningful patient-clinician communication is one mechanism posited to underlie these findings (6). However, not all data support a link between PROM use and better communication (7). Barriers to PROMs as communication tools include challenges with PROM administration, use of PROMs of low importance to patients, and inadequate patient and clinician buy-in. These challenges may be amplified in the fast-paced dialysis environment, where nephrologists have expressed hesitation about PROMs due to resource and time constraints (8). In this issue of CJASN, Schick-Makaroff et al. (9) present a longitudinal mixed-methods study examining the influence of routine PROM use on patient-clinician communication in hemodialysis care. The study was conducted concurrently with the Evaluation of Routinely Measured Patient-Reported Outcomes in Hemodialysis Care (EMPATHY) trial, a 17-clinic cluster randomized controlled trial in Canada testing the effectiveness of routinely administered symptom and/or quality of life PROMs on patient-clinician communication and other outcomes. Primary trial results have not yet been published. In this study, the authors drew upon baseline and 12-month responses to a modified Communication Assessment Tool (CAT)—a validated measure of patient perceptions of clinician communication skills—and data from patient and nurse interviews, in-clinic observations, and patient responses to open-ended survey questions. Results showed that routine PROM use did not improve patient-clinician communication; the change in baseline to 12-month CAT scores did not differ between clinics administering PROMs every 2 months and clinics not administering PROMs. However, the relatively high baseline CAT scores in both intervention and control clinics are noteworthy and suggest reasonably high-quality patient-clinician communication pretrial. Qualitative data analysis uncovered potential reasons for the absence of an effect of PROM use on communication. Explanatory factors included insufficient patient and clinician understanding of the purpose of PROMs, challenges with PROM administration, inconsistencies with using PROMs as communication tools, and limited patient- and clinician-perceived value of PROMs. Although these findings are disappointing, they are not necessarily surprising, and they highlight the difficulties in implementing complex interventions in the dialysis setting. On the surface, administering surveys to people receiving hemodialysis hardly seems like a complex task. However, numerous choreographed steps must be completed successfully for PROMs to positively affect patient-clinician communication and health outcomes (Figure 1). Disruption of any step compromises the potential effectiveness of PROMs and, even more importantly, may erode patient trust, damaging the very outcomes PROMs are intended to improve.Figure 1.: How patient-reported outcome measures (PROMs) may improve patient-clinician communication.First, PROMs will fail from the outset if patients do not complete them. This can occur for many reasons, including insufficient patient understanding of content, operational challenges arising from visual impairment or other physical limitations, or negative past survey experiences. Subsequently, PROM processes break down when results do not reach the intended clinicians or when clinicians receive the results but do not follow up with patients about their responses. The latter is particularly detrimental as it leaves patients feeling that their concerns are unimportant and that their time is unvalued. Moreover, PROM follow-up is essential if clinicians are to gain deeper understanding of patient experiences, context that cannot be captured by Likert scales. Further, isolated follow-up is often not enough. Clinicians must routinely check back with patients to assess for intervention response and changes in condition. Failure to do so may leave issues unresolved and patients feeling forgotten. However, as demonstrated in oncology, when PROMs with consistent clinician follow-up are implemented as intended, they can strengthen patient-clinician communication by heightening clinician awareness of patient-prioritized concerns, enhancing rapport, and fostering shared decision making (7). As reported by the study authors, there were numerous breakdowns of PROM implementation at EMPATHY intervention clinics. Issues with PROM completion arose from patients having insufficient understanding of PROM questions and response options, patients receiving too much assistance with PROMs, and nurses presenting the PROMs to patients in a negative light. Meaningful follow-up was hindered by the lack of continuity in dialysis clinicians, uncertainty of nurses about handling PROM results seemingly in conflict with clinical assessments, and patient perceptions that the PROMs were generic and not individualized to their needs. These challenges occurred despite the use of flexible implementation protocols that allowed for clinic-level adaptations intended to promote protocol fidelity. Study results should, however, be considered in the context of the qualitative data limitations. It is possible that key perspectives were missed due to the relatively few interviews (ten patients, eight nurses, and zero physicians) and observations (six clinics). As such, it is difficult to assess the transferability of findings to other EMPATHY clinics where interviews were not performed and beyond. However, the authors should be commended for collecting and integrating diverse data types to evaluate the implementation of PROMs while concurrently studying their effectiveness—a proven strategy for accelerating the uptake of research findings in clinical practice that, to date, has been underutilized in kidney research (10). Drawing upon approaches from the growing field of implementation science is one opportunity to improve the deployment of complex interventions, like PROMs, in the dialysis setting. Although implementation science typically focuses on methods to promote the integration of interventions with proven effectiveness into real-world care, many of its principles also apply to the implementation of interventions in effectiveness research. Additionally, the field's emphasis on transdisciplinary collaboration and stakeholder engagement is particularly relevant to dialysis, a multilevel setting with numerous individual, organization, and system stakeholders. For example, implementation science conceptual frameworks could be used prior to the conduct of a large randomized clinical trial to structure assessments of context and identify potential barriers to intervention implementation. Conducting stakeholder interviews and surveys as well as performing pilot studies are ways to collect these data and gain insights into intervention acceptability, appropriateness, and feasibility. Such preparatory work not only uncovers issues that need to be addressed prior to broader implementation but also creates opportunity to codevelop solutions with relevant stakeholders. Although the findings reported by Schick-Makaroff et al. (9) stand in contrast to theoretical frameworks and evidence on PROM use from other populations (4–7), they provide invaluable insights into the complexities of implementing multifaceted interventions in the dialysis setting. Incorporating implementation science principles into the deployment of complex interventions is one opportunity to influence the informativeness of clinical trials and ultimately, facilitate the sustained integration of effective stakeholder-acceptable interventions into routine practice. Although the effectiveness of routine PROM use for improving patient-centered outcomes in dialysis care has not yet been established, it is becoming increasingly apparent that the devil of PROM effectiveness may be in the details of PROM implementation. Disclosures In the last 3 years, J.E. Flythe has received speaking honoraria from the American Society of Nephrology and multiple universities as well as investigator-initiated research funding unrelated to this project from the Renal Research Institute, a subsidiary of Fresenius Kidney Care, North America. She serves on a medical advisory board for Fresenius Kidney Care, North America, as well as a scientific advisory board and a data and safety monitoring committee for the National Institute of Diabetes and Digestive and Kidney Diseases. J.E. Flythe reports consultancy agreements with AstraZeneca and serves as the Kidney Health Initiative Patient Preferences Project Chairperson, a Kidney360 associate editor, and a Patient-Centered Outcomes Research Institute peer review associate editor. Funding None.