Background Physicians’ unpreparedness to conduct conversations around serious illness creates a barrier to initiating effective goals of care conversations. Teaching primary palliative care communication skills in medical school is paramount to overcome this barrier. Objective To evaluate the effectiveness of an innovative, immersive primary palliative care communication skills workshop for fourth-year medical students and to incorporate professional actors with teaching experience into the medical school curriculum. Methods An interactive, scenario-based, day-long workshop utilizing professional actors as faculty was developed and conducted multiple times annually for 4 years. Students completed online surveys before, immediately after, and 3-6 months after the workshop. Likert scales assessed student self-perceived comfort with skills learned and short response queries evaluated student experiences. Descriptive statistics and one-way ANOVA repeated measures test were used. Qualitative data was double coded and thematically analyzed. Results 226 students participated in the workshop; 100%. Responded to the pre-survey, 170 (75.2%) responded to the post-survey, and 133 (58.8%) responded to the post-3-6 months survey. The mean self-perceived comfort between the pre-survey and both post- and post-3-6 months surveys was statistically significant ( P < 0.05) for all skills taught. Students reported integrating learned skills and found subjective success in their improved approaches to communication with patients. Conclusion An innovative primary palliative care communication skills workshop using trained professional actors improved and maintained fourth-year medical students’ self-perceived primary palliative care communication skills. Widespread education of primary palliative care communication skills to medical students with trained actors as faculty could improve physician-patient communication around goals of care.

In dialysis, the inclusion of patient-reported outcomes is relatively new. However, the genesis of patient-reported outcomes as an essential component to measuring the quality of care began over 50 years ago. Although much progress has been made, there are still substantial efforts needed to reach true patient-centeredness in health care quality assessment. Patient-centeredness is an iterative, collaborative process of shared decision-making among stakeholders to identify, address, and resolve issues of importance to patients. This shift to putting patients at the forefront of decision-making requires consideration and implementation of ethical principles. Opportunities for patient participation in quality assessment are broad and representation is necessary to avoid exacerbating health inequities and to achieve varied viewpoints. Many resources exist for selecting instruments that assess patient-reported outcomes and barriers to implementation on all levels must be considered before selecting an instrument for quality assessment. Particular attention needs to be paid to the respondent burden from the patient's point of view. Thoughtful implementation of new initiatives that include patients as equal stakeholders could finally propel quality assessment in kidney disease to meet the vision proposed be Avedis Donabedian over 50 years ago.

Many people across the spectrum of chronic kidney disease (CKD) experience a large symptom burden. Measuring symptoms can be a way of responding to the concerns of patients and their priorities of care and may help to improve overall outcomes, including health-related quality of life. The objective of this article is to discuss approaches to measuring symptoms across the spectrum of CKD and to highlight strategies to facilitate the incorporation of routine symptom assessment into kidney care. Specifically, we discuss the use of validated patient-reported outcome measures in CKD as they relate to measuring symptoms, including their benefits and limitations, and describe commonly used patient-reported outcome measures. We discuss potential barriers that should be considered when contemplating the development of a program to routinely measure and address symptoms. Finally, we outline a systematic, stepwise approach to measuring symptoms with implementation strategies to address the common barriers. Although the principles outlined in this article can be applied to research and audit, the principal focus is on symptom measurement aimed at informing clinical practice and directly improving patient outcomes.

Background Clinical practice guidelines emphasize shared decision-making for kidney replacement treatment, yet little is known about the influence of cultural differences on that process. We undertook a retrospective chart review to explore the process and timing of dialysis decision making and initiation in Chinese American patients to provide quality kidney care for this population. Design Participants received outpatient care at Tufts Medical Center and dialysis at Dialysis Clinic, Inc. Boston or Somerville, MA from 2001–2021. Clinic chart review sourced demographic, clinical, and end-of-life care information from 180 participants (82 Chinese American, 98 other) from stage 4 chronic kidney disease (CKD) and dialysis initiation. Results Chinese American participants were older (mean 70 vs. 59, p < 0.0001), less likely to speak English (12% vs. 87%, p < 0.0001), and used interpreter services more (80% vs. 11%, p < 0.0001). Chinese American participants had more visits (median 14 vs. 10, p = 0.005); were more often accompanied by family members (75% vs. 40%, p < 0.001); and had significantly lower rates of healthcare proxy documentation (35% vs. 55%, p = 0.006). There was no statistical difference in months between first CKD 4 visit and first dialysis. Both groups started dialysis at the same average eGFR and with similar rates of permanent dialysis access. Chinese American participants had significantly lower serum albumin at dialysis initiation (mean 3.3 g/dL vs 3.7 g/dL, p = 0.0003). Documentation reflected a low number of conversations about non-dialytic care, end-of-life planning, or palliative care in both groups across all visits. Conclusion The time between CKD 4 and dialysis initiation was the same in both groups, suggesting a similar overall outcome of care. Chart documentation suggests that Chinese American participants had a significantly higher number of visits with nephrologists where discussion about dialysis was noted and were more likely to have a family member present at the visit. Fewer Chinese American participants completed healthcare proxies. Among all study participants, healthcare proxy, code status, and palliative care discussions were reported less frequently than expected. These findings highlight opportunities for collaboration between palliative care clinicians and nephrologists.

Outcomes1. Understand factors influencing patients' decision processes regarding life prolonging treatment of dialysis.2. Explore opportunities for palliative care intervention within other disciplines of medicine to improve patient care and understanding of choices.Key MessageWe found similarities in all study participants in their decision to extend life using dialysis regardless of cultural background. Exception to this included the use of TCM to delay dialysis. All participants didn't think they had choices when starting or continuing dialysis. It appears patients and clinicians rely on clinical data (numbers, laboratory values) to make decision to start dialysis.Abstract: Background: Kidney Disease Improving Global Outcomes guidelines emphasize a shared decision-making process to prepare for kidney failure yet make no recommendations about the influence of culture on these processes. [1] The paucity of evidence about Chinese patients’ decision process motivated this qualitative research to gain understanding about thought processes influencing Chinese Americans’ decision to start dialysis.MethodsSemi-structured interviews of 27 adults (13 English speaking, 14 Chinese speaking) receiving dialysis at Tufts Medical Center located in Boston's Chinatown were conducted in English, Cantonese, and Mandarin using an interviewer guide during a respondent's dialysis session. Interviews were audiotaped, translated if required, transcribed, and analyzed using thematic content analysis and modified grounded theory.ResultsTwo major themes emerged from both group 1) decision motivation: respondents seemed to acquiesce to their nephrologist and discussed death as the only alternative; 2) making decisions based on numbers, i.e., results of laboratory tests and their stage of kidney disease. Additionally, Chinese speaking respondents reported using Traditional Chinese Medicine (TCM) to extend the time until dialysis was needed. Along with themes of the content, the interview process provided unique information including many respondents supplied short answers, some were reluctant to answer, and we identified unclear responses.ConclusionOur qualitative study found similarities in all study participants in their decision to extend life using dialysis regardless of cultural background. Exception to this included the use of TCM as a tool to delay dialysis. Regardless of cultural origin, participants did not think they had choices when starting or continuing dialysis. It appears patients and clinicians rely on clinical data (numbers, laboratory values) to make decision to start dialysis. Postponing the start of dialysis appears to include time spent employing alternative treatments such TCM.KeywordsShared Decision Making / Advance Care Planning / Communication

Incorporating the patient's perspective into the entire product life cycle of medical device development is paramount for ensuring patient-centric evaluation. By prioritizing patient-centric evaluation, medical device developers can better address patient needs and enhance the quality and effectiveness of health care solutions. Patient-reported outcomes (PROs), patient preference information (PPI), and qualitative inquiry are methodologies to incorporate and amplify the patient's voice. In nephrology, unlike in other clinical domains, the utilization of PROs, PPI, and qualitative inquiry in medical device development has been notably sparse. Consequently, a glaring absence of patient involvement in the development of devices leaves the impact of these devices on patient well-being and functionality largely unexplored. Many forward-thinking programs as well as Food and Drug Administration guidance on the use of PROs and PPI are effectively bringing PROs into nephrology device development. Many resources exist to help researchers select high-quality PROs. There are unique considerations for using PROs and PPI to support regulatory decision-making, including fit-for-purpose, concepts of interest, context of use, and least burdensome selection. The rapid evolution of patient-centric initiatives in nephrology will serve to ensure that medical devices meet the needs of people with kidney disease and improve the quality of care.

improvement in their understanding of their CKD and T2D (as applicable) with respect to laboratory values, disease progression and treatments while having a guide to take home and track progress.These patients will be followed, and long-term benefits described in a future publication.

providers with insight into their goals.Future research should explore faith-based interventions and utilize participatory research methods to co-create interventions that can identify pertinent triggers to initiate and guide IACP conversations in the community.

improvement in their understanding of their CKD and T2D (as applicable) with respect to laboratory values, disease progression and treatments while having a guide to take home and track progress.These patients will be followed, and long-term benefits described in a future publication.

Key Points This first step demonstrated content validity for a patient-reported outcome measure for skeletal muscle cramping in dialysis. This work lays the foundation for developing a patient-reported outcome measure for regulatory use to assess skeletal muscle cramping in people receiving dialysis. Background Skeletal muscle cramping is a common, painful, and debilitating symptom experienced by people receiving dialysis. Neither a standardized, patient-endorsed definition of skeletal muscle cramping nor full understanding of patients' perspectives of skeletal muscle cramping exist. We conducted focus groups, within a Kidney Health Initiative (KHI) project, to elicit skeletal muscle cramping experiences of people receiving dialysis as the basis for patient-reported outcome measure (PROM) development. Methods Eligible participants (English-speaking adults aged 18–85 years treated by dialysis and a skeletal muscle cramping episode within 30 days) were purposively recruited from a panel (L&E Research) of people receiving dialysis at home or in-center. Standard qualitative methods were used to conduct virtual 90-minute sessions discussing the following: skeletal muscle cramping clinical characteristics, participants' skeletal muscle cramping experiences, and feedback on a draft skeletal muscle cramping definition and a patient-facing conceptual model developed by the KHI project workgroup. We used qualitative thematic analysis. Results There were 20 diverse participants in three focus groups. Universally experienced skeletal muscle cramping attributes differed by dialysis setting in onset, worst pain rating, duration, and timing. Variably experienced attributes (applied to home and in-center dialysis) were gross and fine motor effect, sleep disruption, mood-related themes of fear, and annoyance/frustration/irritability. Avoidance/adaptive behaviors included reluctance or avoiding movement, adjusting what they ate or drink ( e.g. , yellow mustard, pickles, pickle juice, and tonic water), heat application, massage, and cannabidiol use. The skeletal muscle cramping definition was endorsed, and insightful suggestions for conceptual model were collected. Conclusions This qualitative study of in-center and home patients' skeletal muscle cramping experiences identified universally and variably experienced attributes. The patient-endorsed skeletal muscle cramping definition can serve as a standard for assessment. These results provide the foundation to develop a PROM for regulatory use with people receiving maintenance dialysis who experience skeletal muscle cramping.

Related article, 100374 Related article, 100374 There has been and continues to be great interest in magnesium and dialysis. The results of a simple MEDLINE search showed the earliest listing assessing the ultrafiltration of magnesium in children to be in 1954, with the earliest clinical trials in hemodialysis starting in the early 1970s.1Silverman S.H. Gardner L.I. Ultrafiltration studies on serum magnesium.N Engl J Med. 1954; 250: 938-941Crossref PubMed Google Scholar, 2Schmidt P. Kotzaurek R. Zazgornik J. Hysek H. Magnesium metabolism in patients on regular dialysis treatment.Clin Sci. 1971; 41: 131-139Crossref PubMed Scopus (9) Google Scholar, 3Pletka P. Bernstein D.S. Hampers C.L. Merrill J.P. Sherwood L.M. Effects of magnesium on parathyroid hormone secretion during chronic haemodialysis.Lancet. 1971; 2: 462-463Abstract PubMed Scopus (24) Google Scholar This interest in magnesium and hemodialysis continues to the present day. Although reports in the literature vary, muscle cramping in patients treated with dialysis is common, with the reported prevalence ranging from 12% to 80%.4Moledina D.G. Perry Wilson F. Pharmacologic treatment of common symptoms in dialysis patients: a narrative review.Semin Dial. 2015; 28: 377-383Crossref PubMed Scopus (17) Google Scholar, 5Figueiredo A.E. Goodlad C. Clemenger M. et al.Evaluation of physical symptoms in patients on peritoneal dialysis.Int J Nephrol. 2012; : 305424PubMed Google Scholar, 6Allen R.E. Kirby K.A. Nocturnal leg cramps.Am Fam Physician. 2012; 86: 350-355PubMed Google Scholar Muscle cramps are painful, occur suddenly, vary in duration, and can occur at any time. This common symptom in patients receiving dialysis results in poor quality of life, negatively affects sleep, and contributes to anxiety and depression.7Flythe J.E. Dorough A. Narendra J.H. Forfang D. Hartwell L. Abdel-Rahman E. Perspectives on symptom experiences and symptom reporting among individuals on hemodialysis.Nephrol Dial Transplant. 2018; 33: 1842-1852Crossref PubMed Scopus (24) Google Scholar Patients may shorten or miss dialysis treatment sessions because of cramping.4Moledina D.G. Perry Wilson F. Pharmacologic treatment of common symptoms in dialysis patients: a narrative review.Semin Dial. 2015; 28: 377-383Crossref PubMed Scopus (17) Google Scholar Despite being a common symptom with significant negative effects on patients, the pathophysiology of muscle cramping in patients receiving dialysis is poorly understood. Many therapeutic strategies have been unsuccessful in alleviating muscle cramping.8Varghese A, Lacson E II, Sontrop JM, et al. A higher concentration of dialysate magnesium to reduce the frequency of muscle cramps: a narrative review. Can J Kidney Health Dis. Published online October 22, 2020. https://doi.org/10.1177/2054358120964078Google Scholar Patients have reported using remedies such as pickle juice or yellow mustard.9Flythe J.E. Hilliard T. Lumby E. et al.Fostering innovation in symptom management among hemodialysis patients: paths forward for insomnia, muscle cramps, and fatigue.Clin J Am Soc Nephrol. 2019; 14: 150-160Crossref PubMed Scopus (32) Google Scholar The gaps in understanding the pathophysiology of muscle cramping in patients receiving dialysis likely hinder innovation in preventing or treating muscle cramping in patients treated with dialysis. In this issue of Kidney Medicine, Srisuwarn et al10Srisuwarn P. Sethakarun S. Nongnuch A. et al.Dialysate magnesium and coronary artery calcification, bone mineral density, and cramping in maintenance hemodialysis: a quasi-experimental study.Kidney Med. 2022; 4: 100374Abstract Full Text Full Text PDF Scopus (1) Google Scholar report the results of the MIRACAL study, a study with a quasiexperimental design conducted at 6 centers in Bangkok, Thailand. The study examined the effect of a high dialysate magnesium concentration, defined as 1.75 mEq/L, on coronary artery calcification and bone mineral density. The predefined primary outcomes were changes in the coronary artery calcification score and bone mineral density from those at baseline. The predefined secondary outcomes were changes in laboratory data and the rate of coronary artery calcification progression. Adult in-center hemodialysis patients with a life expectancy of >6 months and an Agaston score of ≥300 were eligible. Of 48 eligible patients, the first 20 patients, all treated at 1 of 2 centers, received a high magnesium dialysate concentration. The remaining patients were matched 1:1 on the Agaston score. The study lasted 26 weeks. All the patients were monitored for signs and symptoms of hypermagnesemia by hemodialysis nurses for the first month and then by patient self-report for the remainder of the study. Muscle cramping was not specifically queried; however, the number of muscle cramping episodes was extracted from the medical record. For the primary outcomes, the authors found a significant increase in the coronary artery calcification score from the baseline in both the groups and a nonsignificant tendency for a decline in bone mineral density at several sites. As would be expected, the serum magnesium and ionized magnesium concentrations in the high magnesium dialysate concentration group were significantly higher than those in the standard dialysate magnesium concentration group. There were no statistically significant differences in the secondary outcomes between the groups. Although not a predefined primary or secondary outcome, the authors report a remarkable difference in the number of episodes of muscle cramps reported in the medical record between the 2 groups. Only 2 episodes were reported in the group that received a high magnesium dialysate concentration, and 285 episodes were reported in the standard magnesium dialysate group. The most compelling sentence in the discussion is as follows: “Most patients who were on high magnesium dialysate requested this treatment be continued after study completion largely due to the alleviation of muscle cramps.” As mentioned earlier, no therapeutic strategies to prevent or treat muscle cramping in patients receiving dialysis have shown a benefit, making the above statement even more compelling. At the end of the MIRACAL study, the “patients who were on high magnesium dialysate were switched back to standard dialysate magnesium concentrations. They then experienced muscle cramps and 15 of 20 patients requested to be back on high magnesium dialysate” (S. Disthabanchong, personal communication, October 2021). This is a remarkable finding; to my knowledge, this level of treatment success has not been shown with any other therapeutic strategy. On the surface, this result suggests that a high magnesium dialysate concentration may be an effective approach to preventing or reducing muscle cramping in patients receiving hemodialysis. However, assessing the effect of a high magnesium dialysate concentration on muscle cramping in hemodialysis patients was not a predefined aim of this study, and the data were not collected in a standardized manner. “Hemodialysis nurses did not receive any special training … for assessment of muscle cramps prior to the study. Intradialytic symptoms including muscle cramps were routinely monitored (observed and confirmed by HD nurses or volunteered by the patients) during each HD session and the presence of any intradialytic symptoms were routinely recorded” (S. Disthabanchong, personal communication, October 2021). Although study resources were spent on collecting these interesting data, these results, at best, can be considered anecdotal. This unexpected and potentially important result is of great interest but will require going back to the drawing board to plan additional studies to assess and verify. The study participants’ enthusiasm toward the use of a higher magnesium dialysate concentration, specifically that they connected this intervention with reducing their muscle cramping, aligns with the increasing interest in the field of preventing or treating muscle cramping in patients treated with dialysis. Randomized clinical trials are being planned, and at least 2 Kidney Health Initiative workgroups have focused on this problem.8Varghese A, Lacson E II, Sontrop JM, et al. A higher concentration of dialysate magnesium to reduce the frequency of muscle cramps: a narrative review. Can J Kidney Health Dis. Published online October 22, 2020. https://doi.org/10.1177/2054358120964078Google Scholar The results of the first workgroup demonstrated that patients ranked muscle cramping in the top 3 symptoms to be prioritized for treatment innovation, and the second workgroup will soon publish its recommendations on using patient-reported outcome measures (PROMs) for skeletal muscle cramping in patients treated with dialysis.11Flythe J.E. Hilliard T. Castillo G. et al.Symptom prioritization among adults receiving in-center hemodialysis: a mixed methods study.Clin J Am Soc Nephrol. 2018; 13: 735-745Crossref PubMed Scopus (58) Google Scholar,12Patient-reported outcomes for muscle cramping in patients on dialysis. Kidney Health Initiative.https://khi.asn-online.org/projects/project.aspx?ID=79Date accessed: January 21, 2022Google Scholar This study is an example of a missed opportunity when research solely focuses on traditional “hard” clinical outcomes and does not incorporate PROMs. Symptoms are experienced by patients and, to be accurately recorded, must be documented by the patient in a reliable and valid manner. Research has suggested that symptom reporting is highly variable and often plagued by underreporting, and there are many factors that influence the likelihood of patients reporting their symptoms.7Flythe J.E. Dorough A. Narendra J.H. Forfang D. Hartwell L. Abdel-Rahman E. Perspectives on symptom experiences and symptom reporting among individuals on hemodialysis.Nephrol Dial Transplant. 2018; 33: 1842-1852Crossref PubMed Scopus (24) Google Scholar,13Pugh-Clarke K. Read S.C. Sim J. Symptom experience in non-dialysis-dependent chronic kidney disease: a qualitative descriptive study.J Ren Care. 2017; 43: 197-208Crossref PubMed Scopus (15) Google Scholar Health care providers are known to underrecognize and undertreat symptoms.14Stephens R.J. Hopwood P. Girling D.J. Machin D. Randomized trials with quality of life endpoints: are doctors' ratings of patients' physical symptoms interchangeable with patients’ self-ratings?.Qual Life Res. 1997; 6: 225-236Crossref PubMed Google Scholar, 15Weisbord S.D. Fried L.F. Mor M.K. et al.Renal provider recognition of symptoms in patients on maintenance hemodialysis.Clin J Am Soc Nephrol. 2007; 2: 960-967Crossref PubMed Scopus (188) Google Scholar, 16van der Veer S.N. Aresi G. Gair R. Incorporating patient-reported symptom assessments into routine care for people with chronic kidney disease.Clin Kidney J. 2017; 10: 783-787Crossref PubMed Scopus (16) Google Scholar Assessing symptoms, particularly in a clinical trial, needs to be standardized to avoid bias in reporting, inquiring, and documenting. Psychometrically sound PROMs (ie, surveys or questionnaires) are reproducible and minimize bias in questioning, reporting, and documenting.17Mokkink L.B. Terwee C.B. Patrick D.L. et al.The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study.Qual Life Res. 2010; 19: 539-549Crossref PubMed Scopus (1986) Google Scholar,18Prinsen C.A. Vohra S. Rose M.R. et al.Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’.Trials. 2014; 15: 247Crossref PubMed Scopus (171) Google Scholar The findings of this study would have been much stronger if a PROM was used to assess the effect of a higher magnesium dialysate concentration on the occurrence of muscle cramping instead of relying on clinician documentation and the patients’ self-reports. The authors could have not only systematically and reproducibly assessed the number of cramping episodes but also collected other items of interest, including the timing, location, duration, and severity of muscle cramping. Having reproducible, reliable, and valid data on muscle cramping in the setting of a high magnesium dialysate concentration, compared with those in a setting of a standard magnesium dialysate concentration, would be a giant step forward. In general, there is increasing recognition that PROMs should be considered as key endpoints to be included in clinical trials. The Food and Drug Administration (FDA) Guidance on Supporting Medical Labeling Claims19Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. 2009. US Department of Health and Human Services Food and Drug Administration. Accessed January 21, 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claimsGoogle Scholar and the Recommendations for Interventional Trials (SPIRIT) Patient-Reported Outcomes (PRO) Extension both emphasize that PROMs be included as trial endpoints.19Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. 2009. US Department of Health and Human Services Food and Drug Administration. Accessed January 21, 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claimsGoogle Scholar, 20Calvert M. King M. Mercieca-Bebber R. et al.SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.BMJ Open. 2021; 11e045105Crossref PubMed Scopus (14) Google Scholar, 21Calvert M. Kyte D. Mercieca-Bebber R. et al.Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO Extension.JAMA. 2018; 319: 483-494Crossref PubMed Scopus (292) Google Scholar There are many initiatives in nephrology that are working to elevate the importance of PROMs in clinical research and clinical care. Recent examples include extensive work being done by the Standardised Outcomes in Nephrology (SONG) initiative, Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference, which recommended that PROMs be incorporated into clinical trials and kidney disease care registries, and the American Society of Nephrology Kidney Health Initiative Workgroups.22Aymé S. Bockenhauer D. Day S. et al.Common elements in rare kidney diseases: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference.Kidney Int. 2017; 92: 796-808Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar,23Kidney Health Initiative. Program of American Society of Nephrology.https://khi.asn-online.org/Date accessed: January 21, 2022Google Scholar Using PROMs requires expertise and planning, and this call to action does not suggest that integrating PROMs in clinical trials is easy or that they should always be a primary endpoint. Especially while assessing symptoms, PROMs must have, at a minimum, equal footing with traditional clinical outcomes. Many patients value improved quality of life and symptom improvement more than survival.24Urquhart-Secord R. Craig J.C. Hemmelgarn B. et al.Patient and caregiver priorities for outcomes in hemodialysis: an international nominal group technique study.Am J Kidney Dis. 2016; 68: 444-454Abstract Full Text Full Text PDF PubMed Scopus (160) Google Scholar Now is the time to routinely think out of the traditional box for clinical trials, do things differently, and place patients’ input higher up on the scale of importance. As is suggested by this study’s findings, in doing so, we might just be pleasantly surprised by what we find. Michelle M. Richardson, PharmD Salary support from Dialysis Clinic, Inc. (DCI) was paid to Tufts Medical Center. Dr Richardson received an honorarium from Letters and Sciences to prepare and present a continuing education program. Dr Richardson is a cochair of the Kidney Health Initiative to Develop Measures for Muscle Cramping in Dialysis Patients to Spur Development of Devices and Medicines for Treating this Vexing Condition (unfunded position). Received November 11, 2021, in response to an invitation from the journal. Direct editorial input from the Editor-in-Chief. Accepted in revised form November 25, 2021. Dialysate Magnesium and Coronary Artery Calcification, Bone Mineral Density, and Cramping in Maintenance Hemodialysis: A Quasi-experimental StudyKidney MedicineVol. 4Issue 2PreviewRecent evidence suggests a role for magnesium as a calcification inhibitor. Increased magnesium abundance may attenuate vascular calcification and promote bone formation. Full-Text PDF Open Access

Skeletal muscle cramping is a common and bothersome symptom for patients on maintenance dialysis therapy, regardless of modality, and it has not been prioritized for innovative assessments or treatments. Research to prevent or treat skeletal muscle cramping in patients receiving dialysis is hindered by poorly understood pathophysiology, lack of an accepted definition, and the absence of a standardized measurement method. The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a multidisciplinary workgroup to define a set of patient-reported outcome measures for use in clinical trials to test the effect of new dialysis devices, new KRTs, lifestyle/behavioral modifications, and medications on skeletal muscle cramping. Upon determining that foundational work was necessary, the workgroup undertook a multistep process to elicit concepts central to developing the basis for demonstrating content validity of candidate patient-reported outcome measures for skeletal muscle cramping in patients on dialysis. The workgroup sought to ( 1 ) create an accepted, patient-endorsed definition for skeletal muscle cramping that applies to all dialysis modalities, ( 2 ) construct a conceptual model for developing and evaluating a skeletal muscle cramping–specific patient-reported outcome measure, and ( 3 ) identify potential questions from existing patient-reported outcome measures that could be modified or adapted and subsequently tested in the dialysis population. We report the results of the workgroup's efforts, provide our recommendations, and issue a call to action to address the gaps in knowledge and research needs we identified. These action steps are urgently needed to quantify skeletal muscle cramping burden, assess the effect, and measure meaningful changes of new interventions to improve the experience of patients receiving dialysis and suffering from skeletal muscle cramping.

The study of patient-reported outcomes, now common in clinical research, had its origins in social and scientific developments during the latter twentieth century. Patient-reported outcomes comprise functional and health status, health-related quality of life, and quality of life. The terms overlap and are used inconsistently, and these terms should be distinguished from expressions of preference regarding health states. Regulatory standards from the USA and European Union provide some guidance regarding reporting of patient-reported outcomes. Determining that patient-reported outcomes measurement is important depends in part on the balance between subjective and objective outcomes of the health problem under study. Instrument selection depends to a large extent on practical considerations. A number of instruments can be identified that are frequently used in particular clinical situations. The domain coverage of commonly used generic short forms varies substantially. Individualized measurement of quality of life is possible, but resource intensive. Focus groups are useful, not only for scale development but also to confirm the appropriateness of existing instruments. Under classical test theory, validity and reliability are the critical characteristics of tests. Under item response theory, validity remains central, but the focus moves from the reliability of scales to the relative levels of traits in individuals and items' relative difficulty. Plans for clinical studies should include an explicit model of the relationship of patient-reported outcomes to other parameters, as well as define the magnitude of difference in patient-reported outcomes that will be considered important. It is particularly important to minimize missing patient-reported outcome data; to a limited extent, a variety of statistical techniques can mitigate the consequences of missing data.

Patient experience is an integral aspect of the care we deliver to our dialysis patients. Standardized evaluation of patient experience with in-center hemodialysis started in the United States in 2012 with the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey. Over time there have been a few changes to this survey, how it is administered, and how it fits within the Centers for Medicare & Medicaid Services End-Stage Renal Disease Quality Incentive Program. Although the importance of this survey has been growing, knowledge of this survey among nephrologists has lagged. We provide a review of the survey development and how its use has evolved since 2012. We discuss in detail research done on this survey to date, including survey psychometric evaluation. We highlight gaps in our knowledge that need further research and end with general recommendations to improve patient experience within hemodialysis facilities, which we believe is a worthy goal for all members of the dialysis team.