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.

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.

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.

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.

Organ donation and transplant: The Islamic perspective.

Islam is the second most practiced religion globally, and the number of Muslims in Western countries has been increasing due to recent trends in migration. Studies have shown that Muslims in the Western world have more negative attitudes toward organ donation and transplantation compared with individuals from other religious backgrounds. Multiple barriers have been postulated that may prevent Muslims from exploring organ donation or transplantation. We conducted a literature review with the goal of summarizing the opinions of major Sunni and Shia scholars and Islamic bodies about organ donation and transplantation, including their opinions and rulings on the neurological determination of death to inform healthcare professionals, community members, and leaders. We also identified factors and attitudes that may prevent members of the Muslim community from achieving equitable access to transplantation or from consenting to donate organs during life or after death. Key factors or concerns identified included: lack of information regarding organ donation, mistrust of the healthcare system, family opinions, sacredness of the body, lack of clear understanding of religious rulings, and opinions of religious leaders. Studies have suggested that partnering with religious leaders to address these concerns may help foster positive attitudes toward organ donation and transplantation.

Evaluating symptom burden in kidney transplant recipients: validation of the revised Edmonton Symptom Assessment System for kidney transplant recipients - a single-center, cross-sectional study.

We assessed the validity of the Edmonton Symptom Assessment System (ESAS-r) in kidney transplant recipients (KTR). A cross-sectional sample of 252 KTR was recruited. Individual ESAS-r symptom scores and symptom domain scores were evaluated. Internal consistency, convergent validity, and construct validity were assessed with Cronbach's α, Spearman's rank correlations, and a priori-defined risk group comparisons. Mean (SD) age was 51 (16), 58% were male, and 58% Caucasian. ESAS-r Physical, Emotional, and Global Symptom Scores demonstrated good internal consistency (α > 0.8 for all). ESAS-r Physical and Global Symptom Scores strongly correlated with PHQ-9 scores (0.72, 95% CI: 0.64-0.78 and 0.74, 95% CI: 0.67-0.80). For a priori-defined risk groups, individual ESAS-r symptom score differed between groups with lower versus higher eGFR [pain: 1 (0-3) vs. 0 (0-2), delta = 0.18; tiredness: 3 (1-5) vs. 1.5 (0-4), delta = 0.21] and lower versus higher hemoglobin [tiredness: 3 (1-6) vs. 2 (0-4), delta = 0.27]. ESAS-r Global and Physical Symptom Scores differed between groups with lower versus higher hemoglobin [13 (6-29) vs. 6.5 (0-18.5), delta = 0.3, and 9 (2-19) vs. 4 (0-13), delta = 0.24] and lower versus higher eGFR [11 (4-20) vs. 6.5 (2-13), delta = 0.21, and 7 (2-16) vs. 3 (0-9), delta = 0.26]. These data support reliability and construct validity of ESAS-r in KTR. Future studies should explore its clinical utility for symptom assessment among KTR.