Development and content validity of a hemodialysis symptom patient-reported outcome measure.

PURPOSE: To describe the process and preliminary qualitative development of a new symptom-based patient-reported outcome measure (PROM) intended to assess hemodialysis treatment-related physical symptoms. METHODS: Experienced interviewers conducted concept elicitation and cognitive debriefing interviews with individuals receiving in-center hemodialysis in the United States. Concept elicitation interviews involved eliciting spontaneous reports of symptom experiences and probing to further explore and confirm concepts. We used patient-reported concepts to generate a preliminary symptom PROM. We conducted 3 rounds of cognitive debriefing interviews to evaluate symptom relevance, item interpretability, and draft item structure. We iteratively refined the measure based on cognitive interview findings. RESULTS: Forty-two adults receiving in-center hemodialysis participated in the concept elicitation interviews. A total of 12 symptoms were reported by > 10% of interviewees. We developed a 13-item initial draft instrument for testing in 3 rounds of cognitive interviews with an additional 52 hemodialysis patients. Participant responses and feedback during cognitive interviews led to changes in symptom descriptions, division of the single item "nausea/vomiting" into 2 distinct items, removal of daily activity interference items, addition of instructions, and clarification about the recall period, among other changes. CONCLUSIONS: Symptom Monitoring on Renal Replacement Therapy-Hemodialysis (SMaRRT-HD™) is a 14-item PROM intended for use in hemodialysis patents. SMaRRT-HD™ uses a single treatment recall period and a 5-point Likert scale to assess symptom severity. Qualitative interview data provide evidence of its content validity. SMaRRT-HD™ is undergoing additional testing to assess measurement properties and inform measure scoring.

Perspectives on Research Participation and Facilitation Among Dialysis Patients, Clinic Personnel, and Medical Providers: A Focus Group Study.

BACKGROUND: Most prospective studies involving individuals receiving maintenance dialysis have been small, and many have had poor clinical translatability. Research relevance can be enhanced through stakeholder engagement. However, little is known about dialysis clinic stakeholders' perceptions of research participation and facilitation. The objective of this study was to characterize the perspectives of dialysis clinic stakeholders (patients, clinic personnel, and medical providers) on: (1) research participation by patients and (2) research facilitation by clinic personnel and medical providers. We also sought to elucidate stakeholder preferences for research communication. STUDY DESIGN: Qualitative study. SETTING & PARTICIPANTS: 7 focus groups (59 participants: 8 clinic managers, 14 nurses/patient care technicians, 8 social workers/dietitians, 11 nephrologists/advanced practice providers, and 18 patients/care partners) from 7 North Carolina dialysis clinics. METHODOLOGY: Clinics and participants were purposively sampled. Focus groups were recorded and transcribed. ANALYTICAL APPROACH: Thematic analysis. RESULTS: We identified 11 themes that captured barriers to and facilitators of research participation by patients and research facilitation by clinic personnel and medical providers. We collapsed these themes into 4 categories to create an organizational framework for considering stakeholder (narrow research understanding, competing personal priorities, and low patient literacy and education levels), relationship (trust, buy-in, and altruistic motivations), research design (convenience, follow-up, and patient incentives), and dialysis clinic (professional demands, teamwork, and communication) aspects that may affect stakeholder interest in participating in or facilitating research. These themes appear to shape the degree of research readiness of a dialysis clinic environment. Participants preferred short research communications delivered in multiple formats. LIMITATIONS: Potential selection bias and inclusion of English-speaking participants only. CONCLUSIONS: Our findings revealed patient interest in participating in research and clinical personnel and medical provider interest in facilitating research. Overall, our results suggest that dialysis clinic research readiness may be enhanced through increased stakeholder research knowledge and alignment of clinical and research activities.

Perspectives on symptom experiences and symptom reporting among individuals on hemodialysis.

Background: Individuals on hemodialysis bear substantial symptom burdens, but providers often underappreciate patient symptoms. In general, standardized, patient-reported symptom data are not captured during routine dialysis care. We undertook this study to better understand patient experiences with symptoms and symptom reporting. In exploratory interviews, we sought to describe hemodialysis nurse and patient care technician perspectives on symptoms and symptom reporting. Methods: We conducted semi-structured interviews with 42 US hemodialysis patients and 13 hemodialysis clinic personnel. Interviews were conducted between February and October 2017 and were analyzed using thematic analysis. Results: Seven themes were identified in patient interviews: (i) symptoms engendering symptoms, (ii) resignation that life is dependent on a machine, (iii) experiencing the life intrusiveness of dialysis, (iv) developing adaptive coping strategies, (v) creating a personal symptom narrative, (vi) negotiating loss of control and (vii) encountering the limits of the dialysis delivery system. Overall, patient symptom experiences and perceptions appeared to influence symptom-reporting tendencies, leading some patients to communicate proactively about symptoms, but others to endure silently all but the most severe symptoms. Three themes were identified in exploratory clinic personnel interviews: (i) searching for symptom explanations, (ii) facing the limits of their roles and (iii) encountering the limits of the dialysis delivery system. In contrast to patients, clinic personnel generally believed that most patients were inclined to spontaneously report their symptoms to providers. Conclusions: Interviews with patients and dialysis clinic personnel suggest that symptom reporting is highly variable and likely influenced by many personal, treatment and environmental factors.

Efficacy, Safety, and Tolerability of Oral Furosemide Among Patients Receiving Hemodialysis: A Pilot Study.

Introduction: Diuretic use may reduce volume-related complications in hemodialysis. We evaluated the efficacy, safety, and tolerability of furosemide in patients with hemodialysis-dependent kidney failure. Methods: We conducted an open label, single-arm, 18-week, dose titration pilot study of oral furosemide (maximum dose 320 mg/day) among patients receiving maintenance hemodialysis who reported at least 1 cup of urine output per day. The primary efficacy outcome was an increase from baseline to a specified threshold of 24-hour urine volume, with the threshold based on baseline urine volume (<200 ml/day vs. ≥200 ml/day). Safety outcomes included hypokalemia and hypomagnesemia, and tolerability was assessed by prespecified patient-reported symptoms. Results: Of the 39 participants, 28 (72%) received the expected furosemide dose, 3 (8%) underwent dose reduction, 5 (12%) discontinued furosemide without dose reduction, and 3 (8%) underwent dose reduction and subsequently discontinued furosemide. The median (quartile 1, quartile 3) baseline 24-hour urine volume was 290 ml (110, 740), and the maximum, average daily study furosemide dose ranged from 69 mg/day to 320 mg/d. The urine output efficacy outcome was met by 12 (33%), 11 (33%), and 7 (22%) participants at weeks 5, 12, and 18, respectively, in the intention-to-treat analysis, and by 12 (39%), 9 (35%), and 7 (28%) participants at weeks 5, 12, and 18, respectively, in the on-treatment analysis. There were no electrolyte, furosemide level, or patient-reported hearing change safety events. Conclusion: Furosemide was generally safe and well tolerated, but only one-third of participants met the efficacy definition at week 5. The clinical importance of the efficacy findings is uncertain.

Stakeholder-Guided Development of Dialysis Vascular Access Education Materials.

Background: Initiating hemodialysis via an arteriovenous (AV) access is considered best practice for most patients. Despite the well-recognized advantages of AV access, 80% of US patients start hemodialysis with a catheter. Limited patient knowledge about vascular access, among other factors, may play a role in this high rate. We used iterative stakeholder input to develop novel, mixed media vascular access education materials and evaluated their preliminary acceptability. Methods: We conducted preliminary focus groups and interviews with key stakeholders to assess patient vascular access understanding and elicit perspectives on existing education materials. We then used stakeholder input to inform initial development and iterative updates to the content and design of an animated video and complementary brochure. Video development (scripting, storyboarding, animation) was guided by an evidence-based framework and two health behavior change models. We assessed acceptability of the completed materials with patients and medical providers/personnel via interviews. Results: Overall, 105 stakeholders participated in education materials development and review (80 patients/care partners, 25 medical providers/personnel). Preliminary qualitative work included 52 patients/care partners and 16 providers/personnel; video development included 28 patients/care partners and nine providers/personnel. The video script, storyboards, and animation underwent 14, four, and nine stakeholder-guided iterations, respectively. Responsive changes included aesthetic modifications, technical updates, and content additions (e.g., HD circuit, access self-monitoring, enhanced patient testimonials). The final 18-minute video and complementary brochure define vascular access types, describe care processes, outline potential complications, and address common patient concerns. Interviews with 28 patients/care partners and nine providers/personnel from diverse geographic regions revealed preliminary acceptability of, and enthusiasm for, the materials by patients and providers. Conclusions: In collaboration with key stakeholders, we developed mixed media vascular access education materials that were well-received by patients and providers. Preliminary findings suggest that the materials are promising to improve vascular access understanding among patients.

Effect of ultrafiltration profiling on outcomes among maintenance hemodialysis patients: a pilot randomized crossover trial.

BACKGROUND: More rapid fluid removal during hemodialysis is associated with adverse cardiovascular outcomes and longer dialysis recovery times. The effect of ultrafiltration (UF) profiling, independent of concomitant sodium profiling, on markers of intradialytic hemodynamics and other outcomes has been inadequately studied. METHODS: Four-phase, blinded crossover trial. Participants (UF rates > 10 mL/h/kg) were assigned in random order to receive hemodialysis with UF profiling (constantly declining UF rate, intervention) vs. hemodialysis with conventional UF (control). Each 3-week 9-treatment period was followed by a 1-week 3-treatment washout period. Participants crossed into each study arm twice (2 phases/arm); 18 treatments per treatment type. The primary outcomes were intradialytic hypotension, pre- to post-dialysis troponin T change, and change from baseline in left ventricular global longitudinal strain. Other outcomes included intradialytic symptoms and blood volume measured-plasma refill (post-dialysis volume status measure), among others. Each participant served as their own control. RESULTS: On average, the 34 randomized patients (mean age 56 years, 24% female, mean dialysis vintage 6.3 years) had UF rates > 10 mL/h/kg in 56% of treatments during the screening period. All but 2 patients completed the 15-week study (prolonged hospitalization, kidney transplant). There was no significant difference in intradialytic hypotension, troponin T change, or left ventricular strain between hemodialysis with UF profiling and conventional UF. With UF profiling, participants had significantly lower odds of light-headedness and plasma refill compared to hemodialysis with conventional UF. CONCLUSIONS: Ultrafiltration (UF) profiling did not reduce the odds of treatment-related cardiac stress but did reduce the odds of light-headedness and post-dialysis hypervolemia. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03301740 (registered October 4, 2017).

Targeting Patient and Health System Barriers To Improve Rates of Hemodialysis Initiation with an Arteriovenous Access.

Background: Guidelines recommend pre-emptive creation of arteriovenous (AV) access. However, <20% of US patients initiate hemodialysis (HD) with a functional AV access. We implemented a quality improvement (QI) program to improve pre-HD vascular access care. Methods: After conducting qualitative research with key informants, we implemented a 7-month vascular access support QI program at Geisinger Health. The program targeted patient and health system barriers to AV access through education, needs assessment, peer support, care navigation, and electronic supports. We performed pre-, intra-, and postprogram stakeholder interviews to identify program barriers and facilitators and to assess acceptability. In a research substudy, we compared pre- and postprogram self-efficacy, knowledge, and confidence navigating vascular access care. Results: There were 37 patient and 32 clinician/personnel participants. Of the 37 patients, 34 (92%) completed vascular access-specific education, 33 (89%) underwent needs assessment, eight (22%) engaged with peer mentors, 21 (57%) had vein mapping, 18 (49%) had an initial surgical appointment, 15 (40%) underwent AV access surgery, and six (16%) started HD during the 7-month program. Qualitative findings demonstrated program acceptability to participants and suggested that education provision and emotional barrier identification were important to engaging patients in vascular access care. Research findings showed pre- to postprogram improvements in patient self-efficacy (28.1-30.8, P=0.05) and knowledge (4.9-6.9, P=0.004), and trends toward improvements in confidence among patients (8.0-8.7, P=0.2) and providers (7.5-7.8, P=0.1). Conclusions: Our intervention targeting patient and health system barriers improved patient vascular access knowledge and self-efficacy. Clinical Trial registry name and registration number: Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation, NCT04032613.

Feasibility of Tablet-Based Patient-Reported Symptom Data Collection Among Hemodialysis Patients.

INTRODUCTION: Individuals receiving in-center hemodialysis have high symptom burdens but often do not report their symptoms to care teams. Evidence from other diseases suggest that use of symptom electronic patient-reported outcome measures (ePROMs) may improve outcomes. We assessed the usability of a symptom ePROM system and then implemented a quality improvement (QI) project with the objective of improving symptom communication at a US hemodialysis clinic. During the project, we assessed the feasibility of ePROM implementation and conducted a substudy exploring the effect of ePROM use on patient-centered care. METHODS: After conducting usability testing, we used mixed methods, guided by the Quality Implementation Framework, to implement a 16-week symptom ePROM QI project. We performed pre-, intra-, and postproject stakeholder interviews to identify implementation barriers and facilitators. We collected ePROM system-generated data on symptoms, e-mail alerts, and response rates, among other factors, to inform our feasibility assessment. We compared pre- and postproject outcomes. RESULTS: There were 62 patient participants (34% black, 16% Spanish-speaking) and 19 care team participants (4 physicians, 15 clinic personnel) at QI project start, and 32 research participants. In total, the symptom ePROM was administered 496 times (completion rate = 84%). The implementation approach and ePROM system were modified to address stakeholder-identified concerns throughout. ePROM implementation was feasible as demonstrated by the program's acceptability, demand, implementation success, practicality, integration in care, and observed trend toward improved outcomes. CONCLUSIONS: Symptom ePROM administration during hemodialysis is feasible. Trials investigating the effectiveness of symptom ePROMs and optimal administration strategies are needed.

Ultrafiltration-profiled hemodialysis to reduce dialysis-related cardiovascular stress: Study protocol for a randomized controlled trial.

Rapid fluid removal (ultrafiltration, UF) is associated with higher cardiovascular morbidity and mortality among individuals receiving maintenance hemodialysis (HD). Fluid removal rates that exceed vascular refill rates can result in hemodynamic instability, end-organ damage to the heart, kidneys, gut and brain, among other organs, and patient symptoms. There are no known evidence-based HD treatment strategies to reduce harm from higher UF rates. Ultrafiltration profiling, the practice of varying UF rates to maximize fluid removal during periods of greatest hydration and plasma oncotic pressure, has been proposed as an HD treatment intervention that may reduce UF rate-related complications. This study is a randomized 4-phase cross-over trial in which participants are successively alternated between study arms with intervening washout periods, and treatment order is randomized. After 4-week screening and 6-week baseline periods, participants are randomized to HD with conventional UF or HD with UF profiling for a period of 3 weeks followed by a 1-week washout period before crossing over. Participants cross into conventional UF and UF profiling phases twice (2 phases per arm). The primary outcomes of interest are intradialytic hypotension (nadir intradialytic systolic blood pressure <90 mmHg), pre-to post-HD change in troponin T (expressed as a percentage), change in left ventricular global longitudinal strain (an echocardiographic measure of left ventricular systolic function), and development of intradialytic left ventricular stunning (worsening of contractile function in ≥2 segments). This study will determine the impact of UF profiling on UF rate-related cardiovascular complications in prevalent, maintenance HD patients.