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Rationale & Objective: Cilastatin is an inhibitor of drug metabolism in the proximal tubule that demonstrates nephroprotective effects in animals. It has been used in humans in combination with the antibiotic imipenem to block imipenem’s renal metabolism. This systematic review and meta-analysis evaluated the nephroprotective effects of cilastatin in humans. Study Design: Systematic review and meta-analysis of observational (comparative effectiveness) studies or randomized clinical trials (RCTs). Setting & Study Populations: People of any age at risk of acute kidney injury (AKI). Selection Criteria for Studies: We systematically searched MEDLINE, Embase, Web of Science, and the Cochrane Controlled Trials registry from database inception to November 2023 for observational studies or RCTs that compared kidney outcomes among groups treated with cilastatin, either alone or as combination imipenem-cilastatin, versus an inactive or active control group not treated with cilastatin. Data Extraction: Two reviewers independently evaluated studies for inclusion and risk of bias. Analytical Approach: Treatment effects were estimated using random-effects models, and heterogeneity was quantified using the I2 statistic. Results: We identified 10 studies (5 RCTs, n = 531 patients; 5 observational studies, n = 6,321 participants) that met the inclusion criteria, including 4 studies with comparisons to inactive controls and 6 studies with comparisons to alternate antibiotics. Based on pooled results from 7 studies, the risk of AKI was lower with imipenem-cilastatin (risk ratio [RR], 0.52; 95% confidence intervals [CI], 0.40-0.67; I2 = 26.5%), with consistent results observed in RCTs (3 RCTs, RR, 0.26; 95% CI, 0.09-0.77; I2 = 44.4%) and observational studies (4 studies, RR, 0.54; 95% CI, 0.41-0.72; I2 = 44.4%). Based on results from 6 studies, serum creatinine concentration was lower following treatment with imipenem-cilastatin than comparators (weighted mean difference in serum creatinine −0.14 mg/dL (95% CI, −0.21 to −0.07; I2 = 0%). The overall certainty of the evidence was low due to heterogeneity of the results, high risk of bias, and indirectness among the identified studies. Limitations: Clinical and statistical heterogeneity could not be fully explained due to a limited number of studies. Conclusions: Patients treated with imipenem-cilastatin developed AKI less frequently and had lower serum creatinine concentration following treatment than control groups or those who had received comparator antibiotics. Larger clinical trials with less risk of detection bias due to lack of allocation concealment and blinding are needed to establish the efficacy of cilastatin for AKI prevention. Plain-Language Summary: Cilastatin, used with the antibiotic imipenem, has shown kidney-protective effects in animals and preclinical studies of acute kidney injury (AKI). This systematic review and meta-analysis identified 10 studies (5 randomized controlled trials and 5 observational studies) of imipenem-cilastatin involving people at risk of AKI. Pooled estimates of treatment effects indicated that patients who received imipenem-cilastatin had a lower incidence of AKI and lower serum creatinine concentrations following treatment compared to comparator groups. Despite these promising findings, the overall certainty of the evidence was low due to heterogeneity among studies, high risk of bias, and indirectness of the data. Although cilastatin appears to be a promising medication for preventing AKI, larger, well-designed trials are needed to establish its effectiveness.

Abstract Storytelling is a powerful means to evoke empathy and understanding among people. When patient partners, which include patients, family members, caregivers and organ donors, share their stories with health professionals, this can prompt listeners to reflect on their practice and consider new ways of driving change in the healthcare system. However, a growing number of patient partners are asked to ‘share their story’ within health care and research settings without adequate support to do so. This may ultimately widen, rather than close, the gap between healthcare practitioners and people affected by chronic disease in this new era of patient and public involvement in research. To better support patient partners with storytelling in the context of a patient-oriented research network, Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD) Network adapted an existing in-person storytelling workshop for patient educators within a hospital setting. The result is a 6-week virtual program called Storytelling for Impact, which guides patients, family members, caregivers and organ donors in developing impactful stories and sharing them at health care and research events, e.g., conferences. The online series of synchronous workshops is co-facilitated by story coaches, who are program alumni and Can-SOLVE CKD staff with trained storytelling experience. Each story follows a structure that includes a call to action, which aims to positively impact the priority-setting and delivery of care and research in Canada. The program has been a transformational process for many who have completed it, and numerous other health organizations have expressed interest in sharing this tool with their own patient partners. As result, we have also created an asynchronous online program that can be used by other interested parties outside our network. Patient partners who share their stories can be powerful mediators for inspiring changes in the health care and research landscape, with adequate structured support. We describe two novel programs to support patient partners in impactful storytelling, which are applicable across all health research disciplines. Additional resources are required for sustainability and scale up of training, by having alumni train future storytellers.

Abstract Introduction Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can‐SOLVE CKD) is a pan‐Canadian health research network that engages patients as partners across 18 unique projects and core infrastructure. In this qualitative study, we explored how research teams integrated patient partners into network research activities to inform our patient engagement approach. Methods To capture a breadth of perspectives, this qualitative descriptive study purposively sampled researchers and patient partners across 18 network research teams. We conducted 4 focus groups (2 patients and 2 researchers; n = 26) and 28 individual telephone interviews (n = 12 patient partners; n = 16 researchers). Transcripts were coded in duplicate, and themes were developed through an inductive, thematic analysis approach. Results We included 24 patient partners and 24 researchers from 17 of the 18 projects and all core committees within the network. Overarching concepts relate participants' initial impressions and uncertainty about patient engagement to an evolving appreciation of its value, impact and sustainability. We identified four themes with subthemes that characterized the dynamic nature of patient engagement and how participants integrated patients across network initiatives: (1) Reinforcing a shared purpose (learning together, collective commitment, evolving attitudes); (2) Fostering a culture of responsive and innovative research (accessible supports, strengthened process and product); (3) Aligning priorities, goals and needs (amenability to patient involvement, mutually productive relationships, harmonizing expectations); (4) Building a path to sustainability (value creation, capacity building, sustaining knowledge use). Conclusions Our findings demonstrate the dynamic and adaptive processes related to patient engagement within a national, patient‐oriented kidney health research network. Optimization of support structures and capacity are key factors to promote sustainability of engagement processes within and beyond the network. Patient or Public Contribution This project was conceived in collaboration with a Can‐SOLVE CKD patient partner (N. F.), with lived experience of kidney failure. He also co‐designed the study′s protocol, led focus groups and researcher interviews, and contributed to data analysis. L. G. has lived experience as a caregiver for a person with CKD and facilitated patient partner focus groups. The patient partners, both of whom are listed authors, provided important insights that shaped our interpretation and presentation of study findings.

Background: Updates to the Kidney Disease Outcomes Quality Initiative Clinical Practice Guideline for Vascular Access emphasize the “right access, in the right patient, at the right time, for the right reasons.” Although this implies a collaborative approach, little is known about how patients, their caregivers, and health care providers engage in vascular access (VA) decision-making. Objective: To explore how the perspectives of patients receiving hemodialysis, their caregivers, and hemodialysis care team align and diverge in relation to VA selection. Design: Qualitative descriptive study. Setting: Five outpatient hemodialysis centers in Calgary, Alberta. Participants: Our purposive sample included 19 patients receiving maintenance hemodialysis, 2 caregivers, and 21 health care providers (7 hemodialysis nurses, 6 VA nurses, and 8 nephrologists). Methods: We conducted semi-structured interviews with consenting participants. Using an inductive thematic analysis approach, we coded transcripts in duplicate and characterized themes addressing our research objective. Results: While participants across roles shared some perspectives related to VA decision-making, we identified areas where views diverged. Areas of alignment included (1) optimizing patient preparedness—acknowledging decisional readiness and timing, and (2) value placed on trusting relationships with the kidney care team—respecting decisional autonomy with guidance. Perspectives diverged in the following aspects: (1) differing VA priorities and preferences—patients’ emphasis on minimizing disruptions to normalcy contrasted with providers’ preferences for fistulas and optimizing biomedical parameters of dialysis; (2) influence of personal and peer experience—patients preferred pragmatic, experiential knowledge, whereas providers emphasized informational credibility; and (3) endpoints for VA review—reassessment of VA decisions was prompted by access dissatisfaction for patients and a medical imperative to achieve a functioning access for health care providers. Limitations: Participation was limited to individuals comfortable communicating in English and from urban, in-center hemodialysis units. Few informal caregivers of people receiving hemodialysis and younger patients participated in this study. Conclusions: Although patients, caregivers, and healthcare providers share perspectives on important aspects of VA decisions, conflicting priorities and preferences may impact the decisional outcome. Findings highlight opportunities to bridge knowledge and readiness gaps and integrate shared decision-making in the VA selection process.

Plain English summary People with kidney failure receiving hemodialysis are faced with complex symptoms that impact their day-to-day functioning and quality of life. Patient-reported outcome measures (PROMs) are tools used by patients to directly communicate symptoms to their care team and guide symptom-focused care. Little is known about how PROMs could be integrated into the team-based care models of outpatient hemodialysis centres. In this study, we conducted interviews with people receiving hemodialysis and their clinicians about their perspectives on how PROMs could support interdisciplinary symptom management (i.e., integration of expertise to achieve common management goals). Participants described how the interrelatedness of symptoms was well suited to an integrated care approach and how PROMs enhanced communication and access to information across team members. In cases where symptoms persisted despite appropriate treatment, patients and clinicians explained how PROMs served as a tool to set realistic goals and reshape illness perception. Findings from this study suggest that access to resources, role flexibility, and established relationships within hemodialysis centres are important for sustaining PROM use in this setting.

Abstract Background Peer support complements traditional models of chronic kidney disease (CKD) care through sharing of peer experiences, pragmatic advice, and resources to enhance chronic kidney disease self-management and decision-making. As peer support is variably offered and integrated into multi-disciplinary CKD care, we aimed to characterize healthcare providers’ experiences and views on peer support provision for people with non-dialysis-dependent CKD within Canada. Methods In this concurrent mixed methods study, we used a self-administered online survey to collect information from multi-disciplinary CKD clinic providers (e.g., nurses, nephrologists, allied health professionals) on peer support awareness, program characteristics and processes, perceived value, and barriers and facilitators to offering peer support in CKD clinics. Results were analyzed descriptively. We undertook semi-structured interviews with a sample of survey respondents to elaborate on perspectives about peer support in CKD care, which we analyzed using inductive, content analysis. Results We surveyed 113 providers from 49 clinics. Two thirds (66%) were aware of formal peer support programs, of whom 19% offered in-house peer support through their clinic. Peer support awareness differed by role and region, and most referrals were made by social workers. Likert scale responses suggested a high perceived need of peer support for people with CKD. Top cited barriers to offering peer support included lack of peer support access and workload demands, while facilitators included systematic clinic processes for peer support integration and alignment with external programs. Across 18 interviews, we identified themes related to peer support awareness, logistics, and accessibility and highlighted a need for integrated support pathways. Conclusions Our findings suggest variability in awareness and availability of peer support among Canadian multi-disciplinary CKD clinics. An understanding of the factors influencing peer support delivery will inform strategies to optimize its uptake for people with advanced CKD.

Abstract Background Clinical pathways aim to improve patient care. We sought to determine whether an online chronic kidney disease (CKD) clinical pathway was associated with improvements in CKD management. Methods We conducted a retrospective pre/post population-based cohort study using linked health data from Alberta, Canada. We included adults 18 years or older with mean estimated glomerular filtration rate (eGFR)

Background: Childhood nephrotic syndrome is a rare kidney disease characterized by sudden onset of edema, massive proteinuria, and hypoalbuminemia. Rare diseases can have a long and difficult trajectory to diagnosis. Objective: We aimed to explore the experiences of children with nephrotic syndrome and their caregivers in their search of a nephrotic syndrome diagnosis. Design: An exploratory, qualitative descriptive study design. Setting: The Alberta Children’s Hospital outpatient nephrology program in Calgary, Alberta, Canada. Sample: Children aged 9 to 18 years with steroid-sensitive nephrotic syndrome and their caregivers. Methods: We undertook semi-structured interviews with children (alone or with a caregiver present) and their caregivers using a question guide suitable to their age and role. We used a thematic analysis approach to inductively code the data and characterize themes related to our research question. Results: Participants included 10 children aged 9 to 18 years (6 boys and 4 girls) and 18 caregivers (8 men and 10 women). We characterized 3 themes related to participants’ experiences in search of a diagnosis of nephrotic syndrome: (1) unexpected and distressing symptom onset, (2) elusiveness of a diagnosis, and (3) encountering a diagnosis. Children with nephrotic syndrome and their caregivers described experiencing initial anxiety due to their unusual and unexpected symptom onset and lack of awareness about the disease. Perceived diagnostic delays and incorrect diagnosis early in the course of the disease contributed to multiple consultations with a variety of care providers. Overall, participants expressed a desire to move past their diagnosis, learn about nephrotic syndrome, and engage in their treatment plans. Limitations: The views expressed by participants may not reflect those of individuals from other settings. The time elapsed since participants’ nephrotic syndrome diagnosis may have influenced their recall of events and reactions to this diagnosis. Conclusions: In characterizing the diagnostic experiences of children and their caregivers, our study provides insight into how patients with nephrotic syndrome and their caregivers can be supported by the healthcare team along this journey. Focused strategies to increase awareness and understanding of nephrotic syndrome among healthcare providers are needed to improve patients’ and families’ diagnostic experiences.

Abstract Background Kidney failure requiring dialysis is associated with poor health outcomes and health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) capture symptom burden, level of functioning and other outcomes from a patient perspective, and can support clinicians to monitor disease progression, address symptoms, and facilitate patient-centered care. While evidence suggests the use of PROMs in clinical practice can lead to improved patient experience in some settings, the impact on patients’ health outcomes and experiences is not fully understood, and their cost-effectiveness in clinical settings is unknown. This study aims to fill these gaps by evaluating the effectiveness and cost-effectiveness of routinely measuring PROMs on patient-reported experience, clinical outcomes, HRQL, and healthcare utilization. Methods The EMPATHY trial is a pragmatic multi-centre cluster randomized controlled trial that will implement and evaluate the use of disease-specific and generic PROMs in three kidney care programs in Canada. In-centre hemodialysis units will be randomized into four groups, whereby patients: 1) complete a disease-specific PROM; 2) complete a generic PROM; 3) complete both types of PROMs; 4) receive usual care and do not complete any PROMs. While clinical care pathways are available to all hemodialysis units in the study, for the three active intervention groups, the results of the PROMs will be linked to treatment aids for clinicians and patients. The primary outcome of this study is patient-provider communication, assessed by the Communication Assessment Tool (CAT). Secondary outcomes include patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated. The present protocol fulfilled the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) checklist. Discussion While using PROMs in clinical practice is supported by theory and rationale, and may engage patients and enhance their role in decisions regarding their care and outcomes, the best approach of their use is still uncertain. It is important to rigorously evaluate such interventions and investments to ensure they provide value for patients and health systems. Trial registration Protocol version (1.0) and trial registration data are available on www.clinicaltrials.gov , identifier: NCT03535922 , registered May 24, 2018.

Background: Intravenous (IV) iron and erythropoietin stimulating agents (ESAs) are standard treatments for anemia in patients receiving maintenance hemodialysis. These medications are associated with significant costs to hemodialysis programs and patients. Recent trial evidence demonstrated that a high-dose IV iron protocol reduces ESA usage and improves cardiovascular outcomes. The cost of implementing a high-dose iron protocol within the Canadian public healthcare context remains unknown. Objective: Our primary aim was to estimate the costs of a high-dose IV iron protocol in a large Canadian hemodialysis program that currently uses a low-dose and reactive IV iron strategy. Our secondary aim was to estimate the reduction in ESA use required to maintain cost neutrality with a high-dose IV iron protocol. Design: In this modeling study of IV iron and ESA utilization from a regional hemodialysis program, changes in medication utilization were calculated based on observed effects from published trial data. Using data from a quality improvement audit of regional anemia management and medication utilization, we estimated potential cost differences under various modeling conditions. Setting: Four adult hospital-based and 9 community in-center hemodialysis units in the Alberta Kidney Care—South renal program during the observation period of September 1, 2018, to November 30, 2018. Patients: In total, data from 826 patients were included. Measurements: Mean monthly IV iron and ESA doses were obtained from routine audit data captured within an electronic medical record. Costs were determined from provincially negotiated medication prices. Methods: Current IV iron and erythropoietin dosages were aggregated at the hemodialysis unit level. We used the results from the PIVOTAL trial to estimate the expected increase in IV iron dose and reduction in ESA dose with a high-dose IV iron protocol. We assumed the split between various manufactures of IV iron and ESA were maintained in our cost model. Total medication costs were aggregated by hemodialysis unit, and the mean costs in each unit were used to estimate per-patient costs. Sensitivity analyses included models that assumed 100% IV iron sucrose usage, as well as models where community hemodialysis units and hospital-based hemodialysis units were examined separately. Finally, we calculated a break-even point for ESA dose reduction required to maintain cost neutrality. Results: Actual baseline IV iron and ESA dose utilization across 13 adult HD units were 118 mg/patient/month (95% confidence interval [CI]: 102-134 mg) and 20,764 IU/pt./mo. (95% CI: 18,104-23,424 IU), respectively. The mean combined cost of ESA and IV iron was $315/pt./mo. (95% CI: $274-$355). In comparison, using the results of the PIVOTAL trial and assuming a high-dose IV iron scenario, we estimated mean IV iron use of 215 mg/pt./mo. (95% CI: 187-243 mg/pt./mo.) and a reduction in mean ESA use to 15,923 IU/pt./mo. (95% CI: 13,883-17,962 IU/pt./mo.). This resulted in an estimated cost savings of $38/pt./mo. (95% CI: $33–$42/pt./mo.) and a total program savings of $370,000 per year (95% CI: $325,000-$420,000). Sensitivity analyses under various alternate conditions also showed potential cost savings. We estimated that a dose reduction of ESA of 10% would be required for cost neutrality with a high-dose IV iron protocol. Limitations: Our study is limited in its use of data from a single randomized controlled trial (RCT) to estimate cost savings rather than actualized utilization. Our models do not take into consideration anticipated reductions in transfusions and hospitalizations that could be realized from a high-dose IV iron protocol. Conclusions: Based on cost modeling, a high-dose IV iron protocol could be integrated in large Canadian regional hemodialysis program in a cost saving manner. Programs implementing such a protocol should monitor IV iron and EPO use prospectively to determine if the trial protocol as applied in a real-world setting translates into cost savings.

Purpose: Genetic testing results are currently obtained approximately 1 year after referral to a medical genetics team for autosomal dominant polycystic kidney disease (ADPKD). We evaluated a mainstream genetic testing (MGT) pathway whereby the nephrology team provided pre-test counseling and selection of patients with suspected ADPKD for genetic testing prior to direct patient interaction by a medical geneticist. Sources of information: A multidisciplinary team of nephrologists, genetic counselors, and medical geneticists developed an MGT pathway for ADPKD using current testing criteria for adult patient with suspected ADPKD and literature from MGT in oncology. Methods: An MGT pathway was assessed using a prospective cohort and compared to a retrospective cohort of 56 patients with ADPKD who received genetic testing using the standard, traditional pathway prior to implementing the MGT for ADPKD. The mainstream pathway was evaluated using time to diagnosis, diagnostic yield, and a patient survey to assess patient perceptions of the MGT pathway. Key findings: We assessed 26 patients with ADPKD using the MGT and 18 underwent genetic testing with return of results. Of them, 52 patients had data available for analysis in the traditional control cohort. The time for return of results using our MGT pathway was significantly shorter with a median time to results of 6 months compared to 12 months for the traditional pathway. We identified causative variants in 61% of patients, variants of uncertain significance in 28%, and 10% had negative testing which is in line with expectations from the literature. The patient surveys showed high satisfaction rates with the MGT pathway. Limitations: This report is an evaluation of a new genetic testing pathway restricted to a single, publicly funded health care center. The MGT pathway involved a prospective collection of a limited number of patients with ADPKD with comparison to a retrospective cohort of patients with ADPKD evaluated by standard testing. Implications: A MGT pathway using clearly defined criteria and commercially available gene panels for ADPKD can be successfully implemented in a publicly funded health care system to reduce the time required to obtain genetic results.

Purpose of program: Integrated knowledge translation (IKT) is a collaborative approach whereby knowledge created through health research is utilized in ways that are relevant to the needs of all stakeholders. However, research teams have limited capacity and know-how for achieving IKT, resulting in a disconnect between the generation and application of knowledge. The goal of this report is to describe how IKT research was achieved across a large-scale, patient-oriented research network, Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD). Sources of information: Resources to facilitate knowledge translation (KT) planning across the network were developed by the Can-SOLVE CKD Knowledge User/Knowledge Translation Committee with reference to established Canadian KT and patient engagement tools and frameworks, review of the published and gray literature, and expertise of committee members. Methods: The Can-SOLVE CKD Knowledge User/Knowledge Translation Committee consisting of patient partners, health care providers, policymakers, and researchers provided oversight of the development and implementation of the network’s IKT initiatives. Guided by its strategic framework, the committee developed KT planning templates and review checklists to assist network projects with preparing for dissemination, implementation, and scale and spread of their interventions. The committee has acted in a consultative capacity to facilitate IKT across network initiatives and has supported capacity building through KT activities aimed at network membership and knowledge users more broadly. Key findings: The Can-SOLVE CKD Knowledge User/Knowledge Translation Committee established a nation-wide strategy for KT infrastructure and capacity building. Acting as a knowledge intermediary, the committee has connected research teams with knowledge users across Canada to support practices and policies informed by evidence generated by the network. The committee has developed KT initiatives, including a Community of Practice, whereby participants across different regions and disciplines convene regularly to share health research knowledge and communications strategies relevant to the network. Critically, patients are engaged and contribute throughout the research process. Examples of IKT activities from select projects are provided, as well as ways for sustaining the network’s KT platform. Limitations: The KT resources developed by the committee were adapted from other established resources to meet the needs of the network and have not undergone formal evaluation in this context. Given the broad scope of the network, resources to facilitate implementation and knowledge user engagement may not meet the needs of all initiatives and must be tailored accordingly. Knowledge barriers, including a lack of information and skills related to conceptual and practical aspects of KT, among network members provided a rationale for various KT capacity–building initiatives. Implications: The approach described here offers a practical method for achieving IKT, including how to plan, implement, and sustain initiatives across large-scale health research networks. Within the context of Can-SOLVE CKD, these efforts will shorten knowledge-practice gaps through producing and applying relevant research to improve the lives of people living with kidney disease.

Background: Fatigue is a pervasive symptom among patients with chronic kidney disease (CKD) that is associated with several adverse outcomes, but the incidence of hospitalization for fatigue is unknown. Objective: To explore the association between estimated glomerular filtration rate (eGFR) and incidence of hospitalization for fatigue. Design: Population-based retrospective cohort study using a provincial administrative dataset. Setting: Alberta, Canada. Patients: People above age 18 who had at least 1 outpatient serum creatinine measurement taken in Alberta between January 1, 2009, and December 31, 2016. Measurements: The first outpatient serum creatinine was used to estimate GFR. Hospitalization for fatigue was identified using International Classification of Diseases, Tenth Revision (ICD-10) code R53.x. Methods: Patients were stratified by CKD category based on their index eGFR. We used negative binomial regression to determine if there was an increased incidence of hospitalization for fatigue by declining kidney function (reference eGFR ≥ 60 mL/min/1.73m 2 ). Estimates were stratified by age, and adjusted for age, sex, socioeconomic status, and comorbidity. Results: The study cohort consisted of 2 823 270 adults, with a mean age of 46.1 years and median follow-up duration of 6.0 years; 5 422 hospitalizations for fatigue occurred over 14 703 914 person-years of follow-up. Adjusted rates of hospitalization for fatigue increased with decreasing kidney function, across all age strata. The highest rates were seen in adults on dialysis (adjusted incident rate ratios 24.47, 6.66, and 3.13 for those aged 18 to 64, 65 to 74, and 75+, respectively, compared with eGFR ≥ 60 mL/min/1.73m 2 ). Limitations: Fatigue hospitalization codes have not been validated; reference group limited to adults with at least 1 outpatient serum creatinine measurement; remaining potential for residual confounding. Conclusions: Declining kidney function was associated with increased incidence of hospitalization for fatigue. Further research into ways to address fatigue in the CKD population is warranted. Trial Registration: Not applicable (not a clinical trial).

Purpose of review: Sexual dysfunction occurs commonly in people with chronic kidney disease (CKD) and has been recognized as a research priority. We sought to evaluate the current state of the literature addressing sexual dysfunction in people with CKD and identify barriers and strategies to improve our management of this important symptom. Sources of information: OVID Medline and Google Scholar were searched for English, peer-reviewed studies using keywords and terms related to “Chronic Kidney Disease,” “sexuality,” and “sexual dysfunction OR function.” Methods: In this narrative review, we describe definitions of sexual dysfunction and contributors exacerbated by CKD, barriers to researching sexual dysfunction in people with CKD, and possible avenues for future research. Key findings: Sexual dysfunction is common in people with CKD and results from a combination of kidney disease itself, as well as its associated physical (ie, comorbidities) and nonphysical factors. Barriers to the study of sexual dysfunction in CKD include inconsistent disease definitions, stigma, variable efficacy and safety of established therapies, and evolving gender roles in sexual function. Potential avenues for future research to improve the sexual function in people with CKD may include evaluating the safety and efficacy of established therapies in people with CKD using a variety of observational and interventional study designs, engaging people with CKD and multidisciplinary team members in research, and using implementation science methods to translate what is known about sexual function into clinical practice. Concerted efforts are required to break down barriers and improve sexual function in people with CKD. Patients have identified this as an important research priority, and national networks need to direct efforts to reduce symptom burden. Limitations: This narrative review was limited by a paucity of high-quality studies examining sexual dysfunction specifically in people with kidney disease.

Background: Approximately 10% of emergency department (ED) visits among dialysis patients are for conditions that could potentially be managed in outpatient settings, such as hyperkalemia. Objective: Using population-based data, we derived and internally validated a risk score to identify hemodialysis patients at increased risk of hyperkalemia-related ED events. Design: Retrospective cohort study. Setting: Ten in-center hemodialysis sites in southern Alberta, Canada. Patients: All maintenance hemodialysis patients (≥18 years) between March 2009 and March 2017. Measurements: Predictors of hyperkalemia-related ED events included patient demographics, comorbidities, health-system use, laboratory measurements, and dialysis information. The outcome of interest (hyperkalemia-related ED events) was defined by International Classification of Diseases (10th Revision; ICD-10) codes and/or serum potassium [K + ] ≥6 mmol/L. Methods: Bootstrapped logistic regression was used to derive and internally validate a model of important predictors of hyperkalemia-related ED events. A point system was created based on regression coefficients. Model discrimination was assessed by an optimism-adjusted C-statistic and calibration by deciles of risk and calibration slope. Results: Of the 1533 maintenance hemodialysis patients in our cohort, 331 (21.6%) presented to the ED with 615 hyperkalemia-related ED events. A 9-point scale for risk of a hyperkalemia-related ED event was created with points assigned to 5 strong predictors based on their regression coefficients: ≥1 laboratory measurement of serum K + ≥6 mmol/L in the prior 6 months (3 points); ≥1 Hemoglobin A1C [HbA1C] measurement ≥8% in the prior 12 months (1 point); mean ultrafiltration of ≥10 mL/kg/h over the preceding 2 weeks (2 points); ≥25 hours of cumulative time dialyzing over the preceding 2 weeks (1 point); and dialysis vintage of ≥2 years (2 points). Model discrimination (C-statistic: 0.75) and calibration were good. Limitations: Measures related to health behaviors, social determinants of health, and residual kidney function were not available for inclusion as potential predictors. Conclusions: While this tool requires external validation, it may help identify high-risk patients and allow for preventative strategies to avoid unnecessary ED visits and improve patient quality of life. Trial registration: Not applicable—observational study design.

Plain English summary As knowledge translation trainee participants, we report on the discussions that took place during the 2017 Knowledge Translation Canada Summer Institute. The theme of the institute was patient-oriented research and patient engagement in research. Trying to move knowledge into health care practice can be difficult. Including patients and families as members of the research team can help to overcome some of these challenges by producing more relevant research designs and results. However, in the absence of guidelines and best practices, it can be difficult for trainees and researchers to effectively engage patients and families in designing and conducting research. We detail how trainees and early career researchers are currently engaging patients in their research, the strengths and challenges of engaging patients in research, and lessons learned. These discussions have helped us to identify important areas where future training and guidance is needed to support trainees as patient-oriented researchers. Abstract Background Moving knowledge into health care practice can present a number of challenges for researchers. Including patients and families as members of the research team can help to overcome some of these challenges by producing more relevant research designs and results. However, many trainees and researchers experience difficulty in engaging patients and families in research effectively. Main body We report on the discussions that took place at the 2017 Knowledge Translation (KT) Canada Summer Institute (KTCSI). The theme of the KTCSI was patient-oriented research and patient engagement in research. We provide an important viewpoint on how trainees and early career researchers are currently engaging patients in their research, the strengths and challenges of engaging patients in research, and lessons learned. As the target audience of the KTCSI, we provide our thoughts on what is needed to support trainees and researchers to more effectively engage patients and families in research. Conclusion While many of the participants at the KTCSI are conducting patient-oriented research, practical guidance, resources and tools are needed to ensure the effective engagement of patients in research. These discussions have helped us to identify how to move forward as patient-oriented researchers and where future work and support is needed to achieve effective engagement.

Background: Self-management support interventions are widely accepted in chronic kidney disease (CKD) care; however, interventions rarely consider individual behaviors by incorporating a behavioral theoretical framework. The Theoretical Domains Framework (TDF) can be used to facilitate an understanding of patients and their caregivers’ behaviors to successfully self-manage CKD. Objectives: (1) To understand behaviors of patients with CKD and their caregivers and identify potential intervention approaches to support CKD self-management and (2) to explore relationships between the 14 TDF domains and CKD self-management. Design: Qualitative descriptive study using both content and thematic analysis Setting: Purposive criterion was used to recruit participants from across Canada. Patients: Canadian patients with CKD and their caregivers. Measurements: Focus groups and telephone interviews using a semistructured interview guide. Methods: We conducted a secondary analysis of qualitative data collected from focus groups and telephone interviews from July 2017 to January 2018. Two research team members coded the transcribed data to the 14 TDF domains using a modified approach of the Framework Method. We linked the common TDF domains to relevant intervention functions from the Behaviour Change Wheel (BCW) to identify potential intervention approaches. We also identified and mapped relationships between the relevant TDF domains to report emerging themes. Results: Six focus groups (37 participants) and 11 telephone interview transcripts were analyzed. Five TDF domains that influenced CKD self-management behavior were identified: environmental context and resources, knowledge, beliefs about capabilities, beliefs about consequences, and social influences. Four BCW intervention functions were identified: education, modeling, persuasion, and environmental restructuring. Four emergent themes, shaped by the populated 14 TDF domains, were identified: What does this mean for me? Help me help myself, How does this make me feel? and Who am I? Limitations: The TDF was not used to design the interview guide; therefore, there may be underrepresentation of some TDF domains relevant for self-management. Conclusion: Our findings highlight 5 TDF domains that can influence CKD self-management behavior and 4 possible intervention approaches to influence behavior change in patients with CKD and their caregivers. Emergent themes highlight participants’ interpretation of being diagnosed with CKD, their motivations, feelings, values, and altered identity. This work will inform the codesign of a behavior change intervention to enhance patient self-management of CKD.

Abstract Background Several indirect comparison methods, including network meta-analyses (NMAs), using individual patient data (IPD) have been developed to synthesize evidence from a network of trials. Although IPD indirect comparisons are published with increasing frequency in health care literature, there is no guidance on selecting the appropriate methodology and on reporting the methods and results. Methods In this paper we examine the methods and reporting of indirect comparison methods using IPD. We searched MEDLINE, Embase, the Cochrane Library, and CINAHL from inception until October 2014. We included published and unpublished studies reporting a method, application, or review of indirect comparisons using IPD and at least three interventions. Results We identified 37 papers, including a total of 33 empirical networks. Of these, only 9 (27 %) IPD-NMAs reported the existence of a study protocol, whereas 3 (9 %) studies mentioned that protocols existed without providing a reference. The 33 empirical networks included 24 (73 %) IPD-NMAs and 9 (27 %) matching adjusted indirect comparisons (MAICs). Of the 21 (64 %) networks with at least one closed loop, 19 (90 %) were IPD-NMAs, 13 (68 %) of which evaluated the prerequisite consistency assumption, and only 5 (38 %) of the 13 IPD-NMAs used statistical approaches. The median number of trials included per network was 10 (IQR 4–19) (IPD-NMA: 15 [IQR 8–20]; MAIC: 2 [IQR 3–5]), and the median number of IPD trials included in a network was 3 (IQR 1–9) (IPD-NMA: 6 [IQR 2–11]; MAIC: 2 [IQR 1–2]). Half of the networks (17; 52 %) applied Bayesian hierarchical models (14 one-stage, 1 two-stage, 1 used IPD as an informative prior, 1 unclear-stage), including either IPD alone or with aggregated data (AD). Models for dichotomous and continuous outcomes were available (IPD alone or combined with AD), as were models for time-to-event data (IPD combined with AD). Conclusions One in three indirect comparison methods modeling IPD adjusted results from different trials to estimate effects as if they had come from the same, randomized, population. Key methodological and reporting elements (e.g., evaluation of consistency, existence of study protocol) were often missing from an indirect comparison paper.

Background: Patients and other stakeholders are increasingly engaging as partners in research, although how they perceive such experiences, particularly over the long term, is not well understood. Objective: To characterize how participants from a nondialysis chronic kidney disease (CKD) research priority-setting project conducted 2 years previously perceived the significance of their involvement. Design: Qualitative descriptive study with semi-structured, individual interviews. Setting: Participants resided across Canada. Participants: Eligible participants included stakeholders (ie, patients with nondialysis CKD, caregivers, health care professionals, and policy makers) who had taken part in a prior CKD research priority-setting project. Measurements: We explored stakeholder experiences and perspectives on engagement in CKD research prioritization. Methods: We purposively sampled across stakeholder roles and engagement types (ie, involvement in the priority-setting workshop, wiki online tool, and/or steering committee). All interviews were conducted by a single investigator by telephone or face-to-face, and audio-recordings were transcribed verbatim. The data were inductively coded and analyzed by 2 investigators using a thematic analysis approach. Results: We conducted 23 interviews across stakeholder roles and engagement types. Participants appreciated the integration of distinct stakeholder communities of patients, researchers, and health care professionals that occurred through engagement in research priority setting. Their opportunity to interact with patients and others directly impacted by CKD outside of the clinical setting contributed to an enhanced understanding of the CKD lived experience and value of patient-oriented research. This interaction helped participants refine and refocus their commitment to patient-centered CKD care and research, characterized by enhanced knowledge and confidence (patients/caregivers), adaptations to existing clinical practices and policies (health care providers/policy makers), and subsequent research engagement. Limitations: The views of participants may not reflect those of individuals in other research or health care settings. Conclusions: Stakeholder engagement in nondialysis CKD research prioritization encouraged the integration of stakeholder communities, an appreciation of the CKD experience, and a refocusing of participants’ commitment to research and care. Findings highlight considerations for future health research engaging stakeholders, particularly those living with CKD, as research partners.

Background: Translational research is an evolving discipline that is intended to bridge the gaps between basic science research, clinical research, and implementation in clinical practice. It is a fluid, multidirectional process that requires strong interdisciplinary collaboration to produce research that is relevant to end-users. Purpose of this review: This review summarizes current perspectives on translational research and outlines its relevance and importance to kidney transplantation research. Sources of information: Sources of information used for this review include published reports, articles, and research funding websites. Findings: Tissue typing is used as an in-depth example of how translational research has been applied in the field of kidney transplant medicine, and how it has resulted in successful implementation of diagnostic and management options for sensitized individuals undergoing kidney transplantation. The value of actively involving kidney transplant stakeholders (patients, caregivers, and clinicians) in setting research priorities and determining relevant outcomes for future investigation is also discussed. Limitations: This is a narrative review of the literature which has been partly influenced by the perspectives and experiences of its authors. Implications: Translational and patient-oriented research practices should be incorporated into future research endeavours in the field of kidney transplantation in order to create beneficial change in clinical practice and improve patient outcomes. What was known before: Translational research which engages patients in the investigative process can enhance the likelihood that medical discoveries will have a meaningful impact at the bedside. What this adds: This article applies current perspectives on translational research and patient engagement to the field of kidney transplantation, illustrating how these approaches have led to significant advancements in the field. It provides further justification for deliberate, targeted efforts to cross-collaborate and incorporate the patient voice into kidney transplant research.

Introduction Fatigue is a pervasive symptom of end-stage renal disease (ESRD) that is associated with low quality of life, disability and mortality, and has been identified as a top research priority by patients. We developed a personalised, web-supported educational programme (the Personal Energy Planning (PEP) programme) to teach people with ESRD to use energy management to manage fatigue. Preliminary studies have demonstrated positive effects on fatigue and life participation (ie, the ability to participate in valued day-to-day activities), which justifies the need for a randomised controlled trial (RCT) to better understand the efficacy of the programme. The objectives of the pilot RCT are to estimate RCT eligibility, recruitment and attrition rates, to inform the primary outcome measure and sample size for the RCT and to evaluate treatment fidelity among programme administrators.Methods and analysis A parallel-arm, 1:1 pilot RCT will be conducted at four in-centre haemodialysis units in Calgary, Alberta, Canada. People on haemodialysis who report moderate or severe fatigue on the Fatigue Severity Scale, and meet other study eligibility criteria, will be invited to participate. Consenting participants will be randomised to undergo the 7–9 week ‘PEP’ programme or an active control, and followed for 12 weeks after the programme concludes. Information on eligibility, recruitment and attrition rates will be collected, and questionnaires assessing fatigue and life participation will be administered preintervention, midintervention, immediately postintervention and 12 weeks postintervention. Analyses will include calculation of eligibility, recruitment and attrition rates; power considerations for the full-scale RCT and evaluation of treatment fidelity of programme administrators.Ethics and dissemination Risks associated with this study are minor. Patients may experience emotional discomfort while filling out study questionnaires. They will be advised to skip any questions that make them uncomfortable. Potential benefits of participating include any benefit derived from the study intervention, and contributing to research that may benefit people with kidney disease in the future. Trial results will be disseminated via publication in an academic journal and presentation at academic conferences. The study has been approved by the Conjoint Health Research Ethics Board at the University of Calgary (ID #18-1657).

Abstract Objective: FoodRx is a 12-month healthy food prescription incentive program for people with type 2 diabetes (T2DM) and experiences of household food insecurity. In this study, we aimed to explore potential users’ prospective acceptability (acceptability prior to program use) of the design and delivery of the FoodRx incentive and identify factors influencing prospective acceptability. Design: We used a qualitative descriptive approach and purposive sampling to recruit individuals who were interested or uninterested in using the FoodRx incentive. Semi-structured interviews were guided by the theoretical framework of acceptability, and corresponding interview transcripts were analysed using differential qualitative analysis guided by the socioecological model. Setting: Individuals living in Alberta, Canada. Participants: In total, fifteen adults with T2DM and experiences of household food insecurity. Results: People who were interested in using the FoodRx incentive (n 10) perceived it to be more acceptable than those who were uninterested (n 5). We identified four themes that captured factors that influenced users’ prospective acceptability: (i) participants’ confidence, views and beliefs of FoodRx design and delivery and its future use (intrapersonal), (ii) the shopping routines and roles of individuals in participants’ social networks (interpersonal), (iii) access to and experience with food retail outlets (community), and (iv) income and food access support to cope with the cost of living (policy). Conclusion: Future healthy food prescription programs should consider how factors at all levels of the socioecological model influence program acceptability and use these data to inform program design and delivery.

Objectives Persons with advanced chronic kidney disease (CKD) have unique support needs associated with managing a chronic yet often silent condition, complex treatment-related decisions and care transitions. The aim of this study was to explore perspectives on how peer support could address CKD support needs and augment care.Design This study employed a qualitative descriptive methodology. Data were collected through focus groups (cofacilitated by patient partners) and semistructured interviews.Setting Four multidisciplinary CKD clinics across Southern Alberta, Canada.Participants We purposively sampled among adult patients with advanced, non-dialysis CKD and their caregivers, as well as trained peer mentors from The Kidney Foundation of Canada’s Kidney Connect programme.Analysis Transcripts were coded in duplicate, and themes were generated inductively through a thematic analysis approach.Results We conducted seven focus groups with a total of 39 patient and caregiver participants. Seven patients and caregivers who were unable to attend a focus group and 13 peer mentors participated in a telephone interview. Although patients and caregivers had limited awareness of peer support, participants acknowledged its central role in affirming their experiences and enabling confidence to live well with kidney disease. We identified four themes related to the anticipated role of peer support in addressing support needs for people with non-dialysis CKD: (1) creating connection; (2) preparing for uncertainty; (3) adapting to new realities; and (4) responsive peer support delivery. Aligning peer support access with patient readiness and existing CKD management supports can promote optimism, community and pragmatic adaptations to challenges.Conclusions Patients, caregivers and peer mentors highlighted a unique value in the shared experiences of CKD peers to anticipate and manage disease-related challenges and confidently face a future living with kidney disease.

Background: A significant proportion of hemodialysis patients have functional, but modifiable, vitamin K deficiency. Objective: To determine the correlates of poor vitamin K status in hemodialysis patients. Design: Cross-sectional study. Setting: Hemodialysis units at Kingston General Hospital and its satellite centres, Ontario, Canada. Patients: Patients undergoing outpatient hemodialysis for end-stage kidney disease. Measurements: Serum concentrations of phylloquinone, undercarboxylated prothrombin, also known as protein induced by vitamin K absence or antagonism – factor II (PIVKA-II), and the percentage of undercarboxylated osteocalcin (%ucOC). Methods: Vitamin K status was determined in fasting blood samples of hemodialysis patients. Bivariate relationships were examined using parametric and non-parametric statistics as appropriate. Multivariable linear regression models were applied to identify predictors of vitamin K status. Results: Among 44 HD patients, criteria for subclinical vitamin K deficiency were met in 13.6% (phylloquinone < 0.4 nmol/L), 51% (%ucOC > 20%) and 90.9% (PIVKA-II > 2.0 nmol/L) of subjects. Phylloquinone levels were positively associated with total cholesterol, triglyceride levels and non-smoking status. Higher %ucOC was associated with increased calcium-phosphate product. Increased PIVKA-II levels were observed with advancing age, reduced dialysis adequacy, lower HDL and a history of coronary artery disease. There were no associations found among the individual biomarkers of vitamin K status. In a multi-variable model, triglycerides were the only significant predictor of phylloquinone levels, while increasing phosphate and decreasing PTH were independent predictors of %ucOC. PIVKA-II levels increased by 0.54 nmol/L for every 10-year increase in age. Limitations: Observational study; small sample size. Conclusions: A significant proportion of HD patients met criteria for subclinical vitamin K deficiency. Of the biomarkers measured, PIVKA-II may be superior given its independence of renal function or dyslipidemia, both of which may confound the other vitamin K biomarkers. Studies in patients with ESKD linking biomarkers of vitamin K status to important patient outcomes, including cardiovascular disease, nutritional status and mortality, are required in order to determine the optimal biomarker for evaluating vitamin K status in this particular population.