[Comparison of pain intensity measurements among patients with low-back pain]. / A fájdalom intenzitását méro skálák összehasonlítása ágyéki gerincfájdalommal élok körében.

Background and purpose:

Pain intensity is the most frequently assessed health domain in clinical studies among patients with low-back pain. Visual analogue scale (VAS) and Numeric rating scale (NRS) have been the mostly used measurement tools for pain intensity. We proposed to correlate these instruments to a generic health-related quality of life measurement tool in order to show the scale with superior clinical relevance.

We used cross-sectional, convenience sampling. 120 patients with chronic low-back pain administered the 29-item Patient Reported Outcomes Measurement Information System Profile with NRS included, and the VAS scale in the National Institute of Mental Health, Neurology and Neurosurgery. We determined the correlation between PROMIS domain T-scores and VAS and NRS scores.

We performed Spearman rank correlation test to calculate the correlation coefficient. We found VAS scales measuring pain had weak to moderate correlations with all PROMIS health domains (r = 0.24–0.55). Therefore, we compared correlation of PROMIS domain scores with PROMIS pain intensity numeric rating scale and VAS scales. PROMIS domains had moderate to strong correlations with pain intensity scale (r = 0.45–0.71). PROMIS physical function short form [r = –0.65, 95% CI (–0.75) – (–0.55)] and PROMIS pain interference short form (r = 0.71, 95% CI 0.63 – 0.79) had the strongest correlation with pain intensity item.

NRS has showed greater correlation with PROMIS domain T-scores than VAS scale. This may prove that NRS has greater connection to another health domains, thus it correlated more to health-related quality of life than visual scale. We recommend NRS to use in further clinical studies conducted among patients with low-back pain.

Cannabis use is associated with reduced access to kidney transplantation and an increased risk of acute rejection post-transplant.

BACKGROUND: The association between cannabis use and access to waitlisting, transplantation, and post-transplant outcomes remains uncertain. METHODS: Patients referred for kidney transplant (KT) to the University Health Network from January 1, 2003, to June 30, 2020, and followed until December 31, 2020, were included. Predictors of reported cannabis use were examined using a logistic regression model. The association between cannabis use and time to clearance for KT, undergoing KT, and post-transplant outcomes was evaluated using Cox proportional hazards models. RESULTS: Among 3734 patients, the prevalence of reported cannabis use was 11.8%. Cannabis use was associated with a lower likelihood of KT clearance (adjusted hazard ratio [aHR] .82 [95% confidence interval (CI): .72, .94]). Once cleared for KT, cannabis use did not predict the subsequent receipt of KT (aHR .92, [95% CI: .79, 1.08]). Among 2091 KT recipients, cannabis use was associated with a higher likelihood of biopsy-proven acute rejection (aHR 1.55, [95% CI: 1.06, 2.27]). The relative hazard of death-censored graft failure was similarly elevated (aHR 1.60 [95% CI: .95, 2.72]). Cannabis use did not predict total graft failure (aHR 1.33 [95% CI: .90, 1.96]), death with graft function (aHR 1.06 [95% CI: .59, 1.89]), or hospital readmission in the first-year post-transplant (aHR 1.26 [95% CI: .95, 1.68]). CONCLUSIONS: Cannabis users have less access to transplantation and an increased risk of acute rejection, possibly leading to more graft loss. Further studies are warranted to understand possible mechanisms for the increased risk of allograft immune injury among cannabis users.

Navigating Living Kidney Donation and Transplantation Among South Asian Canadians: The ACTION Project.

RATIONALE & OBJECTIVE: South Asian (SA) Canadians with kidney failure have a 50%-77% lower likelihood of kidney transplant and are less likely to identify potential living donors (LDs). This study aimed to identify health system-, patient-, and community-level barriers and facilitators for accessing LD kidney transplantation in the SA community to inform the development of health system- and community-level interventions to address barriers. STUDY DESIGN: Qualitative study. SETTING & PARTICIPANTS: 20 SA recipients of an LD or deceased-donor kidney transplant, 10 SA LDs, and 41 general SA community members. ANALYTICAL APPROACH: In-depth multilingual interviews were conducted with recipients and LDs. Gender-, language-, and age-stratified focus groups were conducted with general SA community members. Summative content analysis was used to analyze the data. RESULTS: Hesitancy in approaching potential donors, fear about the health of potential LDs, information gaps, language barriers, and challenges evaluating out-of-country donors were highlighted as significant barriers by recipients, and financial concerns and information gaps were identified by donors. Cultural barriers in the SA community were highlighted by donors, recipients, and community members as critical factors when considering donation and transplant; women and elderly SA Canadians highlighted nuanced challenges. Participants reported generally a favorable perception of their health care teams, citing SA representation in the teams as important to providing culturally and linguistically sensitive care. LIMITATIONS: Limited geographic, race, and cultural representation and reliance on virtual data collection. CONCLUSIONS: This study highlights several culturally relevant barriers to donation and transplant that are potentially modifiable through patient-, health system-, and community-focused engagement and education.

Self-reported MeasUrement of Physical and PsychosOcial Symptoms Response Tool (SUPPORT-dialysis): systematic symptom assessment and management in patients on in-centre haemodialysis - a parallel arm, non-randomised feasibility pilot study protocol.

INTRODUCTION: Patients with kidney failure experience symptoms that are often under-recognised and undermanaged. These symptoms negatively impact health-related quality of life and are associated with adverse clinical outcomes. Regular symptom assessment, using electronic patient reported outcomes measure (ePROMs) linked to systematic symptom management, could improve such outcomes. Clinical implementation of ePROMs have been successful in routine oncology care, but not used for patients on dialysis. In this study, we describe a pilot study of ePROM-based systematic symptom monitoring and management intervention in patients treated with in-centre haemodialysis. METHODS AND ANALYSIS: This is a parallel-arm, controlled pilot of adult patients receiving in-centre maintenance haemodialysis. Participants in the intervention arm will complete ePROMs once a month for 6 months. ePROMs will be scored real time and the results will be shared with participants and with the clinical team. Moderate-severe symptoms will be flagged using established cut-off scores. Referral options for those symptoms will be shared with the clinical team, and additional symptom management resources will also be provided for both participants and clinicians. Participants in the control arm will be recruited at a different dialysis unit, to prevent contamination. They will receive usual care, except that they will complete ePROMs without the presentation of results to participants of the clinical team. The primary objectives of the pilot are to assess (1) the feasibility of a larger, randomised clinical effectiveness trial and (2) the acceptability of the intervention. Interviews conducted with participants and staff will be assessed using a content analysis approach. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the University Health Network (REB#21-5199) and the William Osler Health System (#23-0005). All study procedures will be conducted in accordance with the standards of University Health Network research ethics board and with the 1964 Helsinki declaration and its later amendments. Results of this study will be shared with participants, patients on dialysis and other stakeholders using lay language summaries, oral presentations to patients and nephrology professionals. We will also be publishing the results in a peer-reviewed journal and at scientific meetings. PROTOCOL VERSION: 4 (16 November 2022). TRIAL REGISTRATION NUMBER: NCT05515991.

Construct validity of the Hungarian Version of the Patient-Reported Outcomes Measurement Information System-29 Profile Among Patients with Low Back Pain.

OBJECTIVE: We aim to evaluate the psychometric properties of the Hungarian version of the patient-reported outcomes measurement information system (PROMIS)-29 profile domains among patients with chronic low back pain. METHODS: We used a convenience, cross-sectional sampling of patients recruited at our neurosurgical institution. The participants completed paper-pencil version of the PROMIS-29 profile in addition to validated legacy questionnaires, including the Oswestry disability index, Research and Development Corporation 36-item short-form survey, 7-item general anxiety disorder scale, 9-item patient health questionnaire. Reliability was evaluated by calculating the internal consistency (Cronbach's α). Test-retest reliability was assessed using the intraclass correlation coefficient. The structural validity of PROMIS-29 was assessed using a confirmatory factor analysis. Construct validity was assessed by evaluating convergent and discriminant validity using Spearman's rank correlation. To further corroborate the construct validity, we also performed known-group comparisons. RESULTS: The mean age of the 131 participants was 54 ± 16 years. Of the 131 patients, 62% were women. The internal consistency of each PROMIS domain was high (Cronbach's α >0.89 for all). The test-retest reliability was excellent (intraclass correlation >0.97). The confirmatory factor analysis showed good structural validity (comparative fit index >0.96; standardized root mean square residual <0.026 for all domains). All measured PROMIS scores correlated strongly with the scores obtained using the corresponding primary legacy instrument, indicating excellent convergent validity. The known-group comparisons demonstrated differences as hypothesized. CONCLUSIONS: We present data supporting the validity and reliability of the Hungarian PROMIS-29 profile short forms for patients with low back pain. This instrument will be useful for research and clinical applications in spine care.

Knowledge About Renal Transplantation Among African, Caribbean, and Black Canadian Patients With Advanced Kidney Failure.

Introduction: Variable transplant-related knowledge may contribute to inequitable access to living donor kidney transplant (LDKT). We compared transplant-related knowledge between African, Caribbean, and Black (ACB) versus White Canadian patients with kidney failure using the Knowledge Assessment of Renal Transplantation (KART) questionnaire. Methods: This was a cross-sectional cohort study. Data were collected from a cross-sectional convenience sample of adults with kidney failure in Toronto. Participants also answered an exploratory question about their distrust in the kidney allocation system. Clinical characteristics were abstracted from medical records. The potential contribution of distrust to differences in transplant knowledge was assessed in mediation analysis. Results: Among 577 participants (mean [SD] age 57 [14] years, 63% male), 25% were ACB, and 43% were White Canadians. 45% of ACB versus 26% of White participants scored in the lowest tertile of the KART score. The relative risk ratio to be in the lowest tertile for ACB compared to White participants was 2.22 (95% confidence interval [CI]: 1.11, 4.43) after multivariable adjustment. About half of the difference in the knowledge score between ACB versus White patients was mediated by distrust in the kidney allocation system. Conclusion: Participants with kidney failure from ACB communities have less transplant-related knowledge compared to White participants. Distrust is potentially contributing to this difference.

Patient-Reported Outcome Measures for Patients With CKD: The Case for Patient-Reported Outcomes Measurement Information System (PROMIS) Tools.

Chronic kidney disease (CKD), kidney failure, and kidney replacement therapies are associated with high symptom burden and impaired health-related quality of life (HRQOL). Symptoms change with disease progression or transition between treatment modalities and frequently go unreported and unmanaged. Tools that reliably monitor symptoms may improve the management of patients with CKD. Patient-reported outcome measures (PROMs) assess symptom severity; physical, psychological, social, and cognitive functioning; treatment-related side effects; and HRQOL. Systematic use of PROMs can improve patient-provider communication, patient satisfaction, clinical outcomes, and HRQOL. Potential barriers to their use include a lack of engagement, response burden, and limited guidance about PROM collection, score interpretation, and workflow integration. Well-defined, acceptable, and effective clinical response pathways are essential for implementing PROMs. PROMs developed by the Patient-Reported Outcomes Measurement Information System (PROMIS) address some challenges and may be suitable for clinical use among patients with CKD. PROMIS tools assess multiple patient-valued, clinically actionable symptoms and functions. They can be administered as fixed-length, customized short forms or computer adaptive tests, offering precise measurement across a range of symptom severities or function levels, tailored questions to individuals, and reduced question burden. Here we provide an overview of the potential use of PROMs in CKD care, with a focus on PROMIS.

A Qualitative Study on the Effects of the COVID-19 Pandemic on Solid Organ Transplantation.

Introduction: Solid organ transplantation is a lifesaving intervention requiring extensive coordination and communication for timely and safe care. The COVID-19 pandemic posed unique challenges to the safety and management of solid organ transplantation. This descriptive qualitative study aimed to understand how hospital stakeholders were affected by and responded to the COVID-19 pandemic to contribute toward improved healthcare delivery responses and strategies during times of systemic strain on the healthcare system. Methods: One-hour-long semistructured interviews were performed in 3 cohorts: healthcare professionals (N = 6), administrative staff (N = 6), and recipients (N = 4). Interviews were analyzed using conventional thematic content analysis. Thematic saturation was reached within each cohort. Findings: Twelve codes and 6 major themes were identified including the Impact on Clinical Practice, Virtual Healthcare Delivery, Communication, Research, Education and Training, Mental Health and Future Pandemic Planning. Reflecting on these codes and major themes, 4 recommendations were developed (Anticipation and Preparation, Maximizing Existing Resources and Networks, Standardization and the Virtual Environment and Caring for the Staff) to guide transplant programs to optimize healthcare pathways while enhancing the best practices during future pandemics. Conclusion: Transplant programs will benefit from anticipation and preparation procedures using ramping-down strategies, resource planning, and interprofessional collaboration while maximizing existing resources and networks. In parallel, transplant programs should standardize virtual practices and platforms for clinical and educational purposes while maintaining an open culture of mental health discussion and integrating strategies to support staff's mental health.

Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: The EnAKT LKD Cluster Randomized Clinical Trial.

Importance: Patients with advanced chronic kidney disease (CKD) have the best chance for a longer and healthier life if they receive a kidney transplant. However, many barriers prevent patients from receiving a transplant. Objectives: To evaluate the effect of a multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant. Design, Setting, and Participants: This pragmatic, 2-arm, parallel-group, open-label, registry-based, superiority, cluster randomized clinical trial included all 26 CKD programs in Ontario, Canada, from November 1, 2017, to December 31, 2021. These programs provide care for patients with advanced CKD (patients approaching the need for dialysis or receiving maintenance dialysis). Interventions: Using stratified, covariate-constrained randomization, allocation of the CKD programs at a 1:1 ratio was used to compare the multicomponent intervention vs usual care for 4.2 years. The intervention had 4 main components, (1) administrative support to establish local quality improvement teams; (2) transplant educational resources; (3) an initiative for transplant recipients and living donors to share stories and experiences; and (4) program-level performance reports and oversight by administrative leaders. Main Outcomes and Measures: The primary outcome was the rate of steps completed toward receiving a kidney transplant. Each patient could complete up to 4 steps: step 1, referred to a transplant center for evaluation; step 2, had a potential living donor contact a transplant center for evaluation; step 3, added to the deceased donor waitlist; and step 4, received a transplant from a living or deceased donor. Results: The 26 CKD programs (13 intervention, 13 usual care) during the trial period included 20 375 potentially transplant-eligible patients with advanced CKD (intervention group [n = 9780 patients], usual-care group [n = 10 595 patients]). Despite evidence of intervention uptake, the step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years; adjusted hazard ratio, 1.00 (95% CI, 0.87-1.15). Conclusions and Relevance: This novel multicomponent intervention did not significantly increase the rate of completed steps toward receiving a kidney transplant. Improving access to transplantation remains a global priority that requires substantial effort. Trial Registration: ClinicalTrials.gov Identifier: NCT03329521.

Exploring barriers to living donor kidney transplant for African, Caribbean and Black communities in the Greater Toronto Area, Ontario: a qualitative study protocol.

INTRODUCTION: Living donor (LD) kidney transplant (KT) is the best treatment option for many patients with kidney failure as it improves quality of life and survival compared with dialysis and deceased donor KT. Unfortunately, LDKT is underused, especially among groups marginalised by race and ethnicity. African, Caribbean and Black (ACB) patients are 60%-70% less likely to receive LDKT in Canada compared with white patients. Research from the USA and the UK suggests that mistrust, cultural and generational norms, access, and affordability may contribute to inequities. To date, no Canadian studies have explored the beliefs and behaviours related to LDKT in ACB communities. Research approaches that use a critical, community-based approach can help illuminate broader structural factors that may shape individual beliefs and behaviours. In this qualitative study, we will investigate barriers to accessing LDKT in ACB communities in the Greater Toronto Area, to enhance our understanding of the perspectives and experiences of ACB community members, both with and without lived experience of chronic kidney disease (CKD). METHODS AND ANALYSIS: Hospital-based and community-based recruitment strategies will be used to recruit participants for focus groups and individual interviews. Participants will include self-identified ACB individuals with and without experiences of CKD and nephrology professionals. Collaboration with ACB community partners will facilitate a community-based research approach. Data will be analysed using reflexive thematic analysis and critical race theory. Findings will be revised based on feedback from ACB community partners. ETHICS AND DISSEMINATION: This study has been approved by the University Health Network Research Ethics Board UHN REB file #15-9775. Study findings will contribute to the codevelopment of culturally safe and responsive educational materials to raise awareness about CKD and its treatments and to improve equitable access to high-quality kidney care, including LDKT, for ACB patients.

Patient-reported outcomes and patient-reported outcome measures in liver transplantation: a scoping review.

INTRODUCTION: Generic or condition-specific Patient-reported Outcome Measures (PROMs) are used to measure physical, mental, and social aspects of health to promote patient-centered care. This scoping review aims to identify and summarize generic and condition-specific PRO domains and PROMs that have been assessed and used in liver transplant (LT) candidates and recipients. METHODS: We searched Medline, Embase, Cochrane Database of Systematic Reviews and Register of Trials, PsychInfo, and CINAHL from inception to 08/26/2020. Included studies addressed a PRO or PROM in LT candidates or recipients. RESULTS: After screening, 341 studies yielded 189 unique PRO domains. Mental health domains (depression, anxiety, and guilt) were most frequently assessed, followed by domains of physical and social health. Fifty-one generic and three condition-specific unique PROMs were identified, with only 13% (n = 45) of studies including condition-specific tools. DISCUSSION: The most frequent PROMs were the SF-36, Nottingham Health Profile, Hospital Anxiety and Depression Scale, followed by the Liver Disease Quality of Life (LDQoL). Very few studies used transplant-specific PROMs, which may partly be related to the scarcity of LT-specific instruments. We will use these results in future qualitative research to identify PROs and PROMs to build an electronic PROM toolkit to facilitate patient-centered LT care.

Assessing Fatigue in Patients Receiving Kidney Replacement Therapy Using PROMIS Computer Adaptive Testing.

RATIONALE & OBJECTIVE: Fatigue is a debilitating symptom for many patients receiving kidney replacement therapy (KRT). Patient-reported outcome measures can help clinicians identify and manage fatigue efficiently. We assessed the measurement characteristics of the Patient Reported Outcome Measurement Information System (PROMIS)-Fatigue Computer Adaptive Test (PROMIS-F CAT) in patients receiving KRT using the previously validated Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire. STUDY DESIGN: Cross-sectional study. SETTING & PARTICIPANTS: 198 adults treated with dialysis or recipients of a kidney transplant in Toronto, Canada. PREDICTORS: Demographic data, FACIT-F scores, KRT type. OUTCOME: Measurement properties of PROMIS-F CAT T scores. ANALYTICAL APPROACH: Reliability and test-retest reliability were assessed using standard errors of measurement and intraclass correlation coefficient (ICC), respectively. Construct validity was assessed using correlation and comparisons across predefined groups expected to have different levels of fatigue. Receiver operating characteristic (ROC) curves were used to assess the discrimination of PROMIS-F CAT, with clinically relevant fatigue defined by a FACIT-F score of≤30. RESULTS: Of the 198 participants, 57% were male, the mean±SD age was 57±14 years; 65% had received a kidney transplant. Based on the FACIT-F score, 47 patients (24%) had clinically relevant fatigue. PROMIS-F CAT and FACIT-F were strongly correlated (ρ =-0.80, P<0.001). PROMIS-F CAT had excellent reliability (>0.90 for 98% of sample), and good test-retest reliability (ICC=0.85). The ROC analysis demonstrated outstanding discrimination (area under ROC=0.93 [95%, CI 0.89-0.97]). A PROMIS-F CAT cutoff score of≥59 accurately identified most patients with clinically relevant fatigue (sensitivity=0.83; specificity=0.91). LIMITATIONS: A convenience sample of clinically stable patients. FACIT-F items are a part of the PROMIS-F item bank, although there was minimal overlap with only 4 FACIT-F items completed in PROMIS-F CAT. CONCLUSIONS: PROMIS-F CAT has robust measurement properties with low question burden to assess fatigue among patients with KRT.

Health System-Level Barriers to Living Donor Kidney Transplantation: Protocol for a Comparative Case Study Analysis.

BACKGROUND: Living donor kidney transplantation (LDKT) is the best treatment option for patients with kidney failure and offers significant medical and economic advantages for both patients and health systems. Despite this, rates of LDKT in Canada have stagnated and vary significantly across Canadian provinces, the reasons for which are not well understood. Our prior work has suggested that system-level factors may be contributing to these differences. Identifying these factors can help inform system-level interventions to increase LDKT. OBJECTIVE: Our objective is to generate a systemic interpretation of LDKT delivery across provincial health systems with variable performance. We aim to identify the attributes and processes that facilitate the delivery of LDKT to patients, and those that create barriers and compare these across systems with variable performance. These objectives are contextualized within our broader goal of increasing rates of LDKT in Canada, particularly in lower-performing provinces. METHODS: This research takes the form of a qualitative comparative case study analysis of 3 provincial health systems in Canada that have high, moderate, and low rates of LDKT performance (the percentage of LDKT to all kidney transplantations performed). Our approach is underpinned by an understanding of health systems as complex adaptive systems that are multilevel and interconnected, and involve nonlinear interactions between people and organizations, operating within a loosely bounded network. Data collection will comprise semistructured interviews, document reviews, and focus groups. Individual case studies will be conducted and analyzed using inductive thematic analysis. Following this, our comparative analysis will operationalize resource-based theory to compare case study data and generate explanations for our research question. RESULTS: This project was funded from 2020 to 2023. Individual case studies were carried out between November 2020 and August 2022. The comparative case analysis will begin in December 2022 and is expected to conclude in April 2023. Submission of the publication is projected for June 2023. CONCLUSIONS: By investigating health systems as complex adaptive systems and making comparisons across provinces, this study will identify how health systems can improve the delivery of LDKT to patients with kidney failure. Our resource-based theory framework will provide a granular analysis of the attributes and processes that facilitate or create barriers to LDKT delivery across multiple organizations and levels of practice. Our findings will have practice and policy implications and help inform transferrable competencies and system-level interventions conducive to increasing LDKT. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44172.

Older Age is Associated With Lower Utilization of Living Donor Kidney Transplant.

Introduction: Older adults (65 years or older) constitute a substantial and increasing proportion of patients with kidney failure, potentially needing kidney replacement therapy. Living donor kidney transplant (LDKT) offers superior outcomes for suitable patients of all ages. However, exploring LDKT and finding a living donor could be challenging for older adults. Here, we assessed the association between age and utilization of LDKT and assessed effect modification of key variables such as ethnicity and language. Methods: This is a retrospective cohort study of patients with kidney failure referred for kidney transplant (KT) assessment in Toronto between January 2006 and December 2013. The association between age and having a potential living donor identified was assessed using logistic regression and the association between age and the receipt of LDKT was assessed using Cox proportional hazards models. Results: Of the 1617 participants, 50% were middle-aged (45-64 years old), and 17% were ≥65 years old. In our final multivariable adjusted models, compared to young adults, middle-aged and older adults had lower odds of having a potential living donor identified (odds ratio [OR], 0.47; confidence interval [CI], [0.35-0.63]; OR, 0.30; CI, [0.20-0.43]; P < 0.001, for middle-aged and older adults, respectively), and were less likely to receive LDKT (hazard ratio [HR], 0.79; CI, [0.63-0.99]; P = 0.04; HR, 0.47; CI, [0.30-0.72]; P = 0.001, for middle-aged and older adults, respectively.). Conclusion: Age is an independent predictor of receiving LDKT. Considering that nearly 90% of patients with kidney failure in Canada are >45 years of age, these results point to important and potentially modifiable age-related barriers to LDKT.

Psychosocial Distress in Patients With Advanced CKD by Racial Group and Immigrant Status: A Canadian Cross-sectional Study.

RATIONALE & OBJECTIVE: Patients with advanced chronic kidney disease (CKD) have been reported to experience profound psychosocial distress. Other work has established that patients with CKD from marginalized populations (including individuals who on the basis of race often face racism and related discrimination, termed "racialization") experience health care inequities. Given limited information on the intersection of these 2 phenomena, we assessed the association of psychosocial distress with racialized status and immigrant status in Canadians with advanced CKD. STUDY DESIGN: Secondary analysis of cross-sectional data. SETTING & PARTICIPANTS: 536 patients with advanced CKD (estimated glomerular filtration rate<30mL/min/1.73m2, with or without kidney replacement therapy) from multiple clinical centers in Toronto. EXPOSURE: Racialized status (individuals who identify as Asian or as African, Caribbean, or Black Canadian), immigrant status, and combined immigrant-racialized status. OUTCOME: Psychosocial distress, defined as the presence of depression, anxiety, or social difficulties (ie, a score of≥10 points on the Patient Health Questionnaire 9, Generalized Anxiety Disorder 7, or Social Distress 16 scales, respectively). ANALYTICAL APPROACH: The independent associations of racialized status and immigrant status with psychosocial distress, depression, anxiety, and social difficulties were examined using univariable- and multivariable-adjusted logistic regression. RESULTS: Mean age of the 536 participants was 57±16 (SD) years, 62% were male, and 45% were immigrants. Of the sample, 58% were White, 22% were African, Caribbean, or Black Canadian, and 20% were Asian. Psychosocial distress was present in 36% of participants (depression in 19%, anxiety in 12%, and social difficulties in 31%). To assess the combined impact of racialized and immigrant status, we created a variable with mutually exclusive categories: White nonimmigrant, racialized nonimmigrant, White immigrant, and racialized immigrant participants. In our final multivariable-adjusted model, compared with White nonimmigrant participants, racialized immigrant participants were more likely to have psychosocial distress (OR, 2.96 [95% CI, 1.81-4.81]), depression (OR, 1.87 [95% CI, 1.05-3.34]), and social difficulties (OR, 3.36 [95% CI, 2.03-5.57]). Overall similar associations were seen for racialized nonimmigrants and for White immigrants. LIMITATIONS: Convenience sample; small subgroups; combined exposure variable grouping Asian and African, Caribbean, and Black participants together; lack of data about mechanisms. CONCLUSIONS: Both racialized and immigrant status based on self-report of demographic characteristics were associated with psychosocial distress among patients with advanced CKD. These patients may benefit from culturally competent psychosocial support. PLAIN-LANGUAGE SUMMARY: Psychosocial distress is frequent in patients with advanced chronic kidney disease and impacts quality of life and clinical outcomes. Psychosocial distress may be especially scarring in people who are racialized (marginalized on account of their membership in a particular racial group) and/or who are immigrants. We assessed the association of psychosocial distress with racialized and immigrant status in Canadians with advanced chronic kidney disease. Among 536 participants from multiple medical centers in Toronto, we found that racialized and immigrant participants were more likely to have psychosocial distress, depression, and social difficulties compared with White nonimmigrant participants. This is likely related to the multiple intersectional challenges, including experience with racism and discrimination that racialized immigrant patients may face. Further studies are needed to elucidate the specific factors that contribute to more distress. The potential impact of culturally competent and safe support for these patients will also need to be studied.

Prevention and Management of Chronic Postsurgical Pain and Persistent Opioid Use Following Solid Organ Transplantation: Experiences From the Toronto General Hospital Transitional Pain Service.

BACKGROUND: With >700 transplant surgeries performed each year, Toronto General Hospital (TGH) is currently one of the largest adult transplant centers in North America. There is a lack of literature regarding both the identification and management of chronic postsurgical pain (CPSP) after organ transplantation. Since 2014, the TGH Transitional Pain Service (TPS) has helped manage patients who developed CPSP after solid organ transplantation (SOT), including heart, lung, liver, and renal transplants. METHODS: In this retrospective cohort study, we describe the association between opioid consumption, psychological characteristics of pain, and demographic characteristics of 140 SOT patients who participated in the multidisciplinary treatment at the TGH TPS, incorporating psychology and physiotherapy as key parts of our multimodal pain management regimen. RESULTS: Treatment by the multidisciplinary TPS team was associated with significant improvement in pain severity and a reduction in opioid consumption. CONCLUSIONS: Given the risk of CPSP after SOT, robust follow-up and management by a multidisciplinary team should be considered to prevent CPSP, help guide opioid weaning, and provide psychological support to these patients to improve their recovery trajectory and quality of life postoperatively.

Two-step screening for depressive symptoms in patients treated with kidney replacement therapies: a cross-sectional analysis.

BACKGROUND: Systematic screening for depressive symptoms may identify patients who may benefit from clinical assessment and psychosocial support. Here we assess a two-step screening using ultrabrief pre-screeners [Edmonton Symptom Assessment Survey-revised Depression item (ESASr-D) or Patient Health Questionnaire-2 (PHQ-2)] followed by the Patient-Reported Outcomes Measurement Information System Depression questionnaire (PROMIS-D) to identify depressive symptoms in patients on kidney replacement therapies. METHODS: We conducted a cross-sectional study of adults (kidney transplant recipients or treated with dialysis) in Toronto, ON, Canada. We simulated various two-step screening scenarios where only patients above a pre-screening cut-off score on the ESASr-D or PHQ-2 would move to step 2 (PROMIS-D). Screening performance was evaluated by sensitivity, specificity and positive and negative predictive values using the Patient Health Questionnaire-9 (PHQ-9) as the referent. The average number of items completed by patients in different scenarios was reported. RESULTS: Of 480 participants, 60% were male with a mean age of 55 years. Based on PHQ-9, 19% of patients had moderate or severe depressive symptoms. Pre-screening with a PHQ-2 score ≥1 combined with a PROMIS-D score of ≥53 provided the best two-step results (sensitivity 0.81, specificity 0.84, NPV 0.95). Two-step screening also reduces question burden. CONCLUSIONS: A two-step screening using a PHQ-2 score ≥1 followed by a PROMIS-D score ≥53 has good sensitivity and specificity for identifying potentially significant depressive symptoms among patients on kidney replacement therapies. This approach has lower question burden. Screened-in patients will need further clinical assessment to establish a diagnosis.

Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD): Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial.

Background: Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) is a quality improvement intervention designed to enhance access to kidney transplantation and living kidney donation. We conducted a cluster-randomized clinical trial to evaluate the effect of the intervention versus usual care on completing key steps toward receiving a kidney transplant. Objective: To prespecify the statistical analysis plan for the EnAKT LKD trial. Design: The EnAKT LKD trial is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority, clinical trial. Randomization was performed at the level of the chronic kidney disease (CKD) programs (the "clusters"). Setting: Twenty-six CKD programs in Ontario, Canada. Participants: More than 10 000 patients with advanced CKD (ie, patients approaching the need for dialysis or receiving maintenance dialysis) with no recorded contraindication to receiving a kidney transplant. Methods: The trial data (including patient characteristics and outcomes) will be obtained from linked administrative health care databases (the "registry"). Stratified covariate-constrained randomization was used to allocate the 26 CKD programs (1:1) to provide the intervention or usual care from November 1, 2017, to December 31, 2021 (4.17 years). CKD programs in the intervention arm received the following: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Outcomes: The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant waitlist, and (4) patient receives a kidney transplant from a living or deceased donor. Analysis plan: Using an intent-to-treat approach, the primary outcome will be analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs. Trial Status: The EnAKT LKD trial period is November 1, 2017, to December 31, 2021. We expect to analyze and report the results once the data for the trial period is available in linked administrative health care databases. Trial Registration: The EnAKT LKD trial is registered with the U.S. National Institute of Health at clincaltrials.gov (NCT03329521 available at https://clinicaltrials.gov/ct2/show/NCT03329521). Statistical Analytic Plan: Version 1.0 August 26, 2022.

Contexte: EnAKT LKD est une intervention d'amélioration de la qualité visant à améliorer l'accès à la transplantation rénale et au don vivant de rein. Nous avons mené un essai clinique randomisé par grappes afin d'évaluer l'effet de l'intervention, par rapport aux soins habituels, sur le taux d'étapes clés réalisées dans le processus de réception d'une greffe de rein. Objectif: Exposer les grandes lignes du plan d'analyse statistique de l'essai EAKT LKD. Conception: EAKT LKD est un essai clinique pragmatique ouvert, à deux bras, en groupes parallèles, basé sur un registre, et randomisé en grappes. La randomisation a été réalisée au niveau des programmes d'insuffisance rénale chronique (IRC) (les « grappes ¼). Cadre: 26 programmes d'IRC en Ontario (Canada). Sujets: Plus de 10 000 patients atteints d'IRC de stade avancé (des patients approchant le besoin de dialyse ou recevant une hémodialyse d'entretien) sans contre-indication documentée à la greffe rénale. Méthodologie: Les données de l'essai (y compris les caractéristiques et les résultats des patients) seront obtenues à partir de bases de données administratives en santé (le « registre ¼). La randomisation stratifiée avec contraintes de covariables a servi à répartir les 26 programmes d'IRC (1:1) selon qu'ils allaient fournir l'intervention ou les soins habituels entre le 1er novembre 2017 et le 31 décembre 2021 (4,17 ans). Les programmes d'IRC du bras d'intervention ont eu droit au soutien suivant: (1) des équipes locales d'amélioration de la qualité et du soutien administratif; (2) de l'information et des ressources sur mesure pour le personnel, les patients et les donneurs vivants; (3) du soutien de la part de receveurs et de donneurs vivants; et (4) des rapports sur le rendement au niveau du programme et une surveillance assurée par les chefs de programme. Résultats: Le principal critère d'évaluation est le taux d'étapes clés accomplies vers la réception d'une greffe de rein, où jusqu'à quatre étapes uniques par patient seront comptabilisées: (1) le patient est aiguillé vers un centre de transplantation pour évaluation; (2) un possible donneur vivant de rein contacte un centre de transplantation pour un receveur en particulier et amorce son évaluation; (3) le patient est ajouté à la liste d'attente pour une transplantation d'un donneur décédé, et (4) le patient reçoit une greffe de rein d'un donneur vivant ou décédé. Plan d'analyse: Selon une approche fondée sur l'intention de traiter, le critère d'évaluation principal sera analysé au niveau du patient en utilisant un modèle multiétats contraint, corrigé dans les programmes d'IRC en fonction du regroupement. Statut de l'essai: L'essai EnAKT LKD s'est tenu du 1er novembre 2017 au 31 décembre 2021. Nous analyserons les résultats et en rendrons compte dès que les données seront disponibles dans les bases de données administratives couplées du système de santé.

Atorvastatin lowers serum calcium levels in lithium-users: results from a randomized controlled trial.

BACKGROUND: Although lithium is considered the gold-standard treatment for bipolar disorder (BD), it is associated with a variety of major endocrine and metabolic side effects, including parathyroid hormone (PTH) dependent hypercalcemia. Aside from surgery and medication discontinuation, there are limited treatments for hypercalcemia. This paper will assess data from a randomized controlled trial (RCT). METHODS: This is a secondary analysis of an RCT that explored the effects of atorvastatin (n = 27) versus placebo (n = 33) on lithium-induced nephrogenic diabetes insipidus (NDI) in patients with BD and major depressive disorder (MDD) using lithium (n = 60), over a 12-week period. This secondary analysis will explore serum calcium levels and thyroid stimulating hormone (TSH) measured at baseline, week 4, and week 12. RESULTS: At 12-weeks follow-up while adjusting results for baseline, linear regression analyses found that corrected serum calcium levels were significantly lower in the treatment group (mean (M) = 2.30 mmol/L, standard deviation (SD) = 0.07) compared to the placebo group (M = 2.33 mmol/L, SD = 0.07) (ß = - 0.03 (95% C.I.; - 0.0662, - 0.0035), p = 0.03) for lithium users. There were no significant changes in TSH. CONCLUSION: In lithium users with relatively normal calcium levels, receiving atorvastatin was associated with a decrease in serum calcium levels. Although exciting, this is a preliminary finding that needs further investigation with hypercalcemic patients. Future RCTs could examine whether atorvastatin can treat PTH dependent hypercalcemia due to lithium and other causes.

Protocol for a Process Evaluation of the Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) Cluster-Randomized Clinical Trial.

Background: Many patients who would benefit from a kidney transplant never receive one. The Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) pragmatic, cluster-randomized clinical trial is testing whether a multi-component quality improvement intervention, provided in chronic kidney disease (CKD) programs (vs. usual care), can help patients with CKD with no recorded contraindications to kidney transplant complete more steps toward receiving a transplant (primary outcome of the trial). The EnAKT LKD intervention has 4 components: (1) quality Improvement teams and administrative support, (2) improved transplant education for patients and healthcare providers, (3) access to support and (4) program-level performance monitoring. Objective: To conduct a process evaluation of the EnAKT LKD quality improvement intervention to determine if the components were delivered, received, and enacted as designed (fidelity), and if the intervention addressed intended barriers (mechanisms of change). Design: A mixed-methods process evaluation informed by new practice implementation and theories of behavior change. Setting: Chronic kidney disease programs in Ontario, Canada, began receiving the EnAKT LKD intervention on November 1, 2017 and will continue to receive it until December 31, 2021. The process evaluation (interviews and surveys) will occur alongside the trial, between December 2020 to May 2021. Participants: Healthcare providers (eg, dialysis nurses, nephrologists, members of the multi-care kidney clinic team) at Ontario's 27 CKD programs. Methods: We will survey and interview healthcare providers at each CKD program, and complete an intervention implementation checklist. Quantitative data from the surveys and the intervention implementation checklist will assess fidelity to the intervention, while quantitative and qualitative data from surveys and interviews will provide insight into the mechanisms of change. Limitations: The long trial period may result in poor participant recall. Conclusion: This process evaluation will enhance interpretation of the trial findings, guide improvements in the intervention components, and inform future implementation. Trial registration: Clinicaltrials.gov; identifier: NCT03329521.

Contexte: Plusieurs patients qui pourraient tirer profit d'une greffe de rein n'en reçoivent jamais une. L'essai clinique pragmatique et randomisé par grappes EnAKT LKD (Enhance Access to Kidney Transplantation and Living Kidney Donation) vise l'amélioration de l'accès à la transplantation rénale et au don de rein vivant. L'essai examine une intervention d'amélioration de la qualité (par rapport aux soins habituels) à composantes multiples réalisée dans le cadre des programs d'insuffisance rénale chronique (IRC) afin de déterminer si elle peut aider les patients atteints d'une néphropathie chronique sans contre-indications documentées à une greffe rénale à franchir davantage d'étapes vers la réception d'une greffe (principal critère d'évaluation de l'essai). L'intervention EAKT LKD comporte quatre composantes : 1) les équipes d'amélioration de la qualité et le soutien administratif; 2) l'amélioration de l'éducation sur la transplantation destinée aux patients et aux fournisseurs de soins; 3) l'accès au soutien; et 4) le suivi du rendement à l'échelle du program. Objectif: L'évaluation du processus de l'intervention d'amélioration de la qualité EnAKT LKD vise deux objectifs : déterminer si les composants ont été livrés, reçus et mis en œuvre comme prévu (fidélité) et vérifier si l'intervention a permis d'éliminer les obstacles prévus (mécanismes de changement). Type d'étude: Une évaluation de processus à méthodes mixtes fondée sur les théories concernant la mise en œuvre de nouvelles pratiques et les changements de comportement. Cadre: Les programs d'IRC ontariens (Canada) ont commencé à recevoir l'intervention EnAKT LKD le 1er novembre 2017 et ont continué de la recevoir jusqu'au 31 décembre 2021. L'évaluation du processus (sondages et entretiens) s'est effectuée parallèlement à l'essai, de décembre 2020 à mai 2021. Participants: Les fournisseurs de soins (infirmières en dialyze, néphrologues, membres du personnel des cliniques multidisciplinaires en santé rénale) des 27 programs d'IRC ontariens. Méthodologie: Nous allons sonder et interroger les fournisseurs de soins de chaque program d'IRC et nous complèterons une liste vérifiant la mise en œuvre de l'intervention. Les données quantitatives tirées des sondages et listes de vérification permettront d'évaluer la fidélité à l'intervention, alors que les données quantitatives et qualitatives extraites des sondages et des entretiens fourniront un aperçu des mécanismes de changement. Limites: La longue période de l'essai pourrait rendre difficile le rappel des participants. Conclusion: Cette évaluation du processus permettra d'améliorer l'interprétation des résultats de l'essai et de guider l'amélioration des composantes de l'intervention, en plus d'éclairer de futures mises en œuvre. Enregistrement de l'essai: ClinicalTrials.gov; identifiant : NCT03329521.