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.

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.

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.

Screening for symptoms of anxiety and depression in patients treated with renal replacement therapy: utility of the Edmonton Symptom Assessment System-Revised.

PURPOSE: The Edmonton Symptom Assessment System-revised (ESASr) is widely used in clinical oncology to screen for physical and emotional symptoms. The performance of the anxiety and depression items (ESASr-A and ESASr-D, respectively) as screening tools have not been evaluated in patients treated with renal replacement therapy. METHODS: Kidney transplant recipients and patients on dialysis were recruited in Toronto. Patients were classified as having moderate/severe depression and anxiety symptoms using the established cut-off score of ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9) and the General Anxiety Disorder-7 (GAD-7) questionnaires. RESULTS: This study included 931 participants; 62% male, mean age (SD) 55(16), and 52% White. All participants completed ESASr, however only 748 participants completed PHQ-9 and 769 participants completed GAD-7. Correlation between ESASr item scores and legacy scores were moderately strong (ESASr-D/PHQ-9: 0.61; ESASr-A/GAD-7: 0.64). We found good discrimination for moderate/severe depression and anxiety [area under the receiver operating characteristics curve (95% CI) ESASr-D 0.82(0.78-0.86); ESASr-A 0.87 (0.82, 0.92)]. The cut-off ≥ 2 for ESASr-D [Sensitivity = 0.76; Specificity = 0.77; Likelihood Ratio (LR) + = 3.29; LR - = 0.31] and ≥ 4 for ESASr-A (Sensitivity = 0.75; Specificity = 0.87; LR + = 5.76; LR - = 0.29) had the best combination of measurement characteristics. CONCLUSION: The identified ESASr-D and ESASr-A cut-off scores may be used to rule out patients without emotional distress with few false negatives. However, the low sensitivity identified in our analysis suggests that neither ESASr-D or ESASr-A are acceptable as standalone screening tools.

Pretransplant Patient Education in Solid-organ Transplant: A Narrative Review.

Education for pretransplant, solid-organ recipient candidates aims to improve knowledge and understanding about the transplant process, outcomes, and potential complications to support informed, shared decision-making to reduce fears and anxieties about transplant, inform expectations, and facilitate adjustment to posttransplant life. In this review, we summarize novel pretransplant initiatives and approaches to educate solid-organ transplant recipient candidates. First, we review approaches that may be common to all solid-organ transplants, then we summarize interventions specific to kidney, liver, lung, and heart transplant. We describe evidence that emphasizes the need for multidisciplinary approaches to transplant education. We also summarize initiatives that consider online (eHealth) and mobile (mHealth) solutions. Finally, we highlight education initiatives that support racialized or otherwise marginalized communities to improve equitable access to solid-organ transplant. A considerable amount of work has been done in solid-organ transplant since the early 2000s with promising results. However, many studies on education for pretransplant recipient candidates involve relatively small samples and nonrandomized designs and focus on short-term surrogate outcomes. Overall, many of these studies have a high risk of bias. Frequently, interventions assessed are not well characterized or they are combined with administrative and data-driven initiatives into multifaceted interventions, which makes it difficult to assess the impact of the education component on outcomes. In the future, well-designed studies rigorously assessing well-defined surrogate and clinical outcomes will be needed to evaluate the impact of many promising initiatives.