Background: The prevalence of frailty is disproportionately increased in patients with chronic kidney disease (CKD) in comparison with non-CKD counterparts and is the highest in patients on hemodialysis (HD). While the cross-sectional measurement of frailty on HD has been associated with adverse clinical events, there is a paucity of data on longitudinal assessment of frailty and its relationship to outcomes. Objective: The objectives were to (1) evaluate changes in frailty status, level of independence, mood, cognition, and quality of life (QoL) over a 12-month period and (2) explore the relationship between frailty status and level of independence, mood, cognition, and QoL at 2 different time points (at baseline and at 1 year). Design: This is a prospective cohort study involving 100 prevalent HD patients. Setting: Regina General Hospital and Wascana Dialysis Unit in Regina, Saskatchewan, Canada, between January 2015 and January 2017. Patients: One hundred prevalent HD patients underwent frailty assessments using the Fried criteria at baseline and 1 year later. Measurements: Frailty was assessed using the Fried criteria, which included assessments of unintentional weight loss, weakness (handgrip strength), slowness (walking speed), and questionnaires for physical activity and self-perceived exhaustion. Cognition, mood, and QoL were measured using questionnaires (Montreal Cognitive Assessment [MoCA], Geriatric Depression Scale [GDS], and EuroQol [EQ-5D] utility scores and visual analog scale [VAS], respectively). Methods: Frailty status was reported as a binary variable: frail vs. nonfrail (prefrail and robust). Differences across baseline and 1-year groups were assessed using McNemar’s test or Wilcoxon signed-rank test, as appropriate. We assessed the differences between frail and nonfrail groups using the Mann–Whitney U test or chi-square test/Fisher’s exact test where appropriate. Results: Ninety-seven of the 100 patients had complete initial assessments. The median (interquartile range [IQR]) duration of dialysis at baseline was 35.5 (13.75-71.75 months). One year later, 22 had died, 10 refused assessments, and 3 had relocated. In comparison with baseline vs 1 year, the number of frail patients was 68.1% vs. 67.7%; prefrail 26.8% vs. 26.1%; robust 5.1% vs. 6.2%; MoCA ≥24, 69% vs. 64.5%; GDS score ≥ 2, 52.8% vs. 47.7%; median EQ-5D utility score 0.81 vs. 0.77; and median EQ-VAS 60 vs. 50. Similarly, in comparison with baseline vs. 1 year, the number of independent patients was 82% vs. 63%, independent with support 17% vs. 31%, and long-term care home 0% vs. 3.1%. Eighteen of the 22 patients (82%) who died were frail. At 1 year, the median (IQR) MoCA was 24 (19-25) vs. 25 (21-26; P = .039) and median (IQR) GDS was 2 (1-3) vs. 1(0-2; P = .034). Likewise, median (IQR) EQ-5D utility score was 0.78 (0.6-0.82) vs. 0.81 (0.78-0.85; P = .023). There were significant changes in self-care (27% vs. 0%), P = 0.006, and daily activities (68.2% vs. 38.1%), P = 0.021. Limitations: This is a single-center study, so direct inferences must be interpreted in the context of the demographics of the study population. Patients were undergoing dialysis for a median of 36 months before undergoing initial assessment. Conclusions: Frailty and prefrailty in our dialysis patients is near-ubiquitous and will need to be proactively addressed to improve subsequent health care outcomes.
Background: Despite the magnitude of fracture and the consequences in patients receiving hemodialysis, optimal risk assessment tools in this population are not well explored. Frailty and falls—known risk factors for fracture in chronic kidney disease (CKD) and non-CKD populations—are common in patients receiving hemodialysis (HD) therapy. While the relationship between T scores in relation to fractures in patients receiving HD is recognized, there is a paucity of data to the additional contributions of fracture assessment tool (FRAX), frailty status, and falls in its relationship with fracture. Objectives: To evaluate the clinical utility of adding FRAX, frailty status, and falls to T scores at the femoral neck to determine whether it enhances fracture discrimination in patients on maintenance HD. Design: A cross-sectional observational study. Setting: Two main dialysis units in Regina, Saskatchewan, Canada. Patients: A total of 109 patients on maintenance HD at two dialysis units from January 1, 2017, to December 31, 2018, were included in the study. Measurements: Fracture (the main outcome) was documented based on the review of medical charts, self-recall, and additionally vertebral fractures were identified by an x-ray. Areal bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). FRAX score was calculated using an online algorithm based on 11 clinical risk factors. We calculated the FRAX score for hip fracture and major osteoprotoic fracture with and without the inclusion of BMD. Frailty was assessed using the Fried criteria, which included assessments of unintentional weight loss, weakness (handgrip strength), slowness (walking speed), and questionnaires for physical activity and self-perceived exhaustion. Patients were enquired about the history and frequency of falls. Methods: A total of 131 patients underwent frailty assessments at the two dialysis units during the dialysis treatment. Following frailty assessments, they were referred for DXA scans and upon receipt of the results undertook FRAX questionnaires. They were additionally sent for lumbar x-rays and contacted for a history of falls. Association between the BMD-T score, FRAX, frailty status, falls, with fracture were examined with sequential multivariable logistic regression models. Differences were considered statistically significant at P values <.05. Results: A total of 109 patients were included in the data analysis. The composite of fracture occurred in 37.6% of patients. About 59.3% were identified as frail, and 29% of the participants had at least one fall in the last year. On multivariate regression analysis, each lower standard deviation (SD) in femoral neck T score was associated with 48% higher odds of fracture (odds ratio [OR] = 1.48; 95% confidence interval [CI] 1.20-1.68, P = .005). With the inclusion for FRAX scores (hip), the OR for fracture remained significant at 1.38 (OR = 1.38, 95% CI 1.04-1.63, P = .043). The addition of frailty status and history of falls did not further improve the model. Low T score and FRAX were both independent risk factors in patients on HD therapy. Limitations: This is a single-center study with a small sample size which limits the generalizability of the findings. Due to the cross-sectional study, associations identified may be difficult to interpret. Conclusions: Both BMD measurements by DXA and FRAX are useful tools to assess fracture in patients receiving HD. The addition of frailty status and history of falls is not associated with fractures in this population. Larger prospective studies are needed to determine whether the inclusion of frailty and falls to the conventional models will improve fracture assessment in the population receiving HD. Trial Registration: The study was not registered on a publicly accessible registry as it did not involve health care intervention on human participants.
Background: Loin Pain Hematuria Syndrome (LPHS) is a poorly understood clinical condition characterized by severe pain localized to the kidney but in the absence of identifiable urinary tract disease. There is no consensus on optimal treatment strategies for LPHS. Case reports and series have shown renal denervation via catheter-based radiofrequency ablation to be an effective therapeutic option for the treatment of LPHS. To determine whether catheter-based renal denervation is a meaningful addition to the treatment options in these often-difficult-to-treat LPHS patients, a randomized clinical trial is needed. Prior to conducting a definitive trial that focuses on patient outcomes, ensuring the feasibility of undertaking such a trial is required. As such, we will conduct a single-center randomized control feasibility trial designed to determine viability and provide framework and direction for a larger trial. Objective: The objective of the study is to determine whether conducting a randomized trial of renal denervation versus sham procedure is feasible in terms of recruitment and eligibility, and adequacy of follow-up in LPHS patients. Design: Single-center double-blinded, parallel-group, partial crossover, sham-controlled, randomized feasibility trial of 10 LPHS patients. Setting: Regina General Hospital in Regina, Saskatchewan, Canada. Patients: Ten LPHS patients who require opioid therapy. Measurements: The main feasibility outcome measures include proportion of target patients who undergo the procedure (treatment or sham) within 6 months; proportion of randomized participants (treatment or control) who entirely complete the follow-up measures at 6 weeks, 3 and 6 months; proportion of the participants who were randomized to control group, cross over after 6 months and opt-in renal denervation treatment; proportion of the crossover participants who complete the follow-up measures at 6 weeks, 3 and 6 months. Pain will be assessed using Brief Pain Inventory Score, McGill Pain Questionnaire, and a pain diary. Mood, disability, and quality of life will be measured by Center for Epidemiologic Studies Depression Scale, Oswestry Disability Index, EuroQol-5D, and Short Form Health Survey Questionnaire, respectively. Methods: Eligible participants will be randomized into either renal denervation (treatment group) or a sham treatment (control group). Data (pain, quality of life, mood, disability) will be collected from both groups at baseline, 6 weeks, 3 and 6 months after the intervention. After the initial 6-month follow-up is over, the participants who received the sham procedure will cross over into the treatment group and will be followed for an additional 6 months in the same manner as the treatment group. Descriptive statistics will be used to report outcomes for all patients. Limitations: Single-center study, small sample size. Conclusions: The lessons learnt from this trial will lay the framework and direction for conducting a multisite randomized controlled trial involving a larger cohort of patients. Trial registration: ClinicalTrials.gov (NCT04332731).
BACKGROUND AND AIMS Despite the negative impact of fracture in hemodialysis (HD) patients, optimal risk assessment tools in this population are not well explored. Frailty (a syndrome of diminished capacity to respond to health stressors) and falls—known risk factors for fracture—are common in HD patients. While the relationship between T scores in relation to fractures in these patients is recognized, there is a paucity of data to the additional contributions of fracture risk assessment tool (FRAX), frailty and falls in relation to fractures. The clinical, societal and economic impact of fractures necessitates an active response from the HD programs. Therefore, we intended to evaluate the clinical utility of adding these factors to T scores at the femoral neck to determine whether it enhances fracture discrimination in HD patients. METHOD We conducted a cross-sectional study on 131 adult patients receiving HD at two dialysis units in Regina, Saskatchewan, Canada (January 2017–December 2018). After undergoing frailty assessments, patients were referred for dual-energy X-ray absorptiometry (DXA) scans and FRAX questionnaires. They were additionally sent for lumbar X-rays and contacted for a history of falls. The presence of fracture (hips, femur, pelvis, knee, foot, leg, toe, shoulder, elbow, ankle, arm, wrist, spine and lumbar) was documented based on the review of medical charts, self-recall and additionally vertebral fractures were identified by an X-ray. Bone mineral density (BMD) was measured by DXA. FRAX score (the 10-year probability of hip and major osteoporotic fracture) was calculated using an online algorithm based on 11 clinical risk factors with and without the inclusion of BMD. Frailty was assessed using the FRIED criteria (Figure 1). Patients were enquired about the history and frequency of falls. Association between the BMD-T score, FRAX score, frailty status, falls, with fracture were examined with sequential multivariable logistic regression models. The area under the receiver operating characteristic curve analysis was conducted for each model to assess its discrimination ability for fracture outcome (α = 0.05). RESULTS A total of 109 HD patients were included in the data analysis. The composite of fracture occurred in 38% of patients. About 60% were identified as frail, and 29% had at least one fall in the last year. Low T score and FRAX were both independent risk factors in patients on HD therapy. On multivariate analysis, each lower standard deviation in T score was associated with 48% higher odds of fracture [odds ratio (OR) = 1.48; 95% confidence interval (95% CI) 1.20–1.68, P = 0.005]. With the inclusion of FRAX score for hip fracture, the OR for fracture remained significant at 1.38 (OR = 1.38, 95% CI 1.04–1.63, P = 0.04). The addition of frailty status and history of falls did not further improve the model. Model 2 showed better discrimination ability and goodness-of-fit for fracture compared to Model 1 (P = 0.004) (Table). CONCLUSION This is the first study to our knowledge that looked at the independent contribution of frailty and falls in addition to T scores and FRAX in assessing for fractures in patients on HD. Our study showed both BMD measurements by DXA scans and FRAX are useful tools to assess fracture in patients receiving HD. The addition of frailty status and history of falls is not associated with fractures in this population. Results of this study should lead to prospective studies with larger sample sizes prior to DXA scans, FRAX and falls assessment being recommended as standards of care.
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