Evaluation of dialysis centres: values and criteria of the stakeholders.

BACKGROUND: Evaluation of renal replacement therapy with haemodialysis is essential for its improvement. Remarkably, outcomes vary across centres. In addition, the methods used have important epistemological limitations, such as ignoring significant features (e.g., quality of life) or no relevance given to the patient's perspective in the indicator's selection. The present study aimed to determine the opinions and preferences of stakeholders (patients, clinicians, and managers) and establish their relative importance, considering the complexity of their interactions, to facilitate a comprehensive evaluation of haemodialysis centres. METHODS: Successive working groups (WGs) were established using a multicriteria methodology. WG1 created a draft of criteria and sub-criteria, WG2 agreed, using a qualitative structured analysis with pre-established criteria, and WG3 was composed of three face-to-face subgroups (WG3-A, WG3-B, and WG3-C) that weighted them using two methodologies: weighted sum (WS) and analytic hierarchy process (AHP). Subsequently, they determined a preference for the WS or AHP results. Finally, via the Internet, WG4 weighted the criteria and sub-criteria by the method preferred by WG3, and WG5 analysed the results. RESULTS: WG1 and WG2 identified and agreed on the following evaluation criteria: evidence-based variables (EBVs), annual morbidity, annual mortality, patient-reported outcome measures (PROMs), and patient-reported experience measures (PREMs). The EBVs consisted of five sub-criteria: type of vascular access, dialysis dose, haemoglobin concentration, ratio of catheter bacteraemia, and bone mineral disease. The patients rated the PROMs with greater weight than the other stakeholders in both face-to-face WG3 (WS and AHP) and WG4 via the Internet. The type of vascular access was the most valued sub-criterion. A performance matrix of each criterion and sub-criterion is presented as a reference for assessing the results based on the preferences of the stakeholders. CONCLUSIONS: The use of a multicriteria methodology allows the relative importance of the indicators to be determined, reflecting the values of the different stakeholders. In a performance matrix, the inclusion of values and intangible aspects in the evaluation could help in making clinical and organizational decisions.

Acute responses of gastrointestinal hormones to both oral and parenteral intradialytic nutrition.

INTRODUCTION: Intradialytic nutrition (IDN) has been used to improve the nutritional status of malnourished hemodialysis (HD) patients. OBJECTIVE: To evaluate the different effects of parenteral IDN (IDPN) and oral IDN (IDON) on nutrition-related gastrointestinal hormones. PATIENTS AND METHODS: Seven clinically stable HD patients with malnutrition were included. All patients were treated for 1 month with either IDPN or IDON, with a 4-week period of no nutritional support between each type of therapy. On the first day of each nutritional support (IDON or IDPN) we analyzed the acute responses of insulin, ghrelin, and glucagon-like peptide 1 (GLP-1). We compared the areas under the secretory curves (AUC) and the maximum peaks of serum glucose, insulin, ghrelin, and GLP-1. A group of 6 clinically stable HD patients without any type of IDN served as the control group. RESULTS: The acute responses of glucose and insulin to IDN were significantly higher with IDPN than with IDON. The AUC of glucose (602 ± 81 vs. 495 ± 81 mg/dl/h, p < 0.01) and insulin (232 ± 103 vs. 73.8 ± 69 µU/ml/h, p < 0.01) as well as the maximum peaks of glucose (228 ± 41 vs. 177 ± 47 mg/dl, p < 0.05) and insulin (104 ± 46 vs. 29 ± 24 µU/ml, p < 0.01) were significantly higher after IDPN than after IDON. Ghrelin decreased after both IDPN and IDON; however, the decrease was significantly higher with IDPN compared to IDON. The ghrelin nadir was significantly lower in IDPN than in IDON (0.77 ± 0.5 vs. 1.5 ± 0.3, p < 0.05) although the AUC of ghrelin was not significantly different. GLP-1 was significantly increased at 1 h after starting both IDPN and IDON with no significant differences between the groups. CONCLUSION: IDPN induces a higher increase in serum glucose and insulin levels and a greater reduction in serum ghrelin concentrations compared with an equivalent orally administered nutritional supplement.

Challenge of phosphorus control in hemodialysis patients: a problem of adherence?

OBJECTIVE: Few studies have investigated nonadherence to phosphate binders. The aim of this study was to evaluate the degree of adherence of our hemodialysis (HD) patients to phosphate binders and to determine which variables were related to nonadherence to treatment. METHODS: In 165 HD patients, the degree of adherence to the drugs prescribed was studied using the Simplified Medication Adherence Questionnaire. RESULTS: Of patients, 40% were nonadherent. Specific nonadherence to phosphate binder and hypotensive medication was admitted by 21% and 13% of patients, respectively. Nonadherent patients had significantly higher mean serum phosphorus (P) (4.7 ± 0.9 mg/dL vs. 4.4 ± 0.7 mg/dL; p=0.007) and potassium levels (6.3 ± 4.4 mEq/L vs. 5.3 ± 1.4 mEq/L; p=0.04). There was a statistically significant association between mean P levels >5.5 mg/dL in the last 6 months and nonadherence to treatment (X2=4.8; 95% confidence interval [95% CI], 1.0-6.6; p=0.02). No relationship was found between patients with blood pressure levels >140/90 mm Hg and nonadherence to hypotensive medication (X2=0.02; 95% CI, 0.2-4.1; p=0.88). Patients specifically nonadherent to phosphate binders were more likely to have P levels >5.5 mg/dL (X2=4.7; 95% CI, 1.07-6.5; p=0.03). No statistically significant association was found between patients noncompliant with hypotensive agents and those noncompliant with phosphate binders (X2=0.39; 95% CI, 0.4-4.7; p=0.53). There were no significant differences between adherent and nonadherent patients in terms of age, time on hemodialysis, Charlson Comorbidity Index, number of drugs prescribed and number of tablets per day (p>0.05). CONCLUSION: Nonadherence to pharmacological treatment in dialysis patients is high. Nonadherence to phosphate binders was greater than for hypotensive agents, did not coexist in the same patients and had a greater impact on target achievement.

A comparative study of 2 new phosphate binders (sevelamer and lanthanum carbonate) in routine clinical practice.

INTRODUCTION: Lack of adherence may influence the efficiency of phosphate binders. Our clinical hypothesis was that if lanthanum carbonate (LC) might offer some advantage over sevelamer (S), that that would be in those patients in whom serum phosphate (P) levels were not controlled by S or in those requiring high doses of it, presuming that therapeutic compliance with S could be inadequate. The aim of this study was to compare the cost-consequences of changing from S to LC. METHODS: This was a prospective comparative before-after interventional study. Fifty-one hemodialysis patients prescribed a large number of tablets of S (≥ 9 tablets/day) and/or had serum phosphorus (P) levels >5.5 mg/dL were changed from S to LC; 68 patients who did not meet those criteria served as controls. RESULTS: Mean daily number of total phosphate binder tablets was reduced after the introduction of LC (13.9 ± 5.5 at time 0 vs. 7.7 ± 4.6 at 12 months; p<0.001). LC was suspended in 14 patients (31.1%), due to a wish to return to the previous medication (S). Percentage compliance with the objectives recommended by the NFK-KDOQI guidelines improved after the change (patients with P <5.5 mg/dL: 46.9% at month 0 and 72.5% at month 12; p<0.01). The incremental cost of changing from S (month 0) to LC (month 12) was -107.8 monthly, considering only the costs of phosphate binders. LC reached the P objective at a lower cost (euro 582.2 vs. euro 1,038.5; -44%; p<0.01). CONCLUSIONS: A complete change from S to LC in these particular kinds of patients significantly decreased the cost of treatment while also improving the achievement of NFK-KDOQI guideline objectives for mineral metabolism.

[Renal biopsy in patients aged 65 years or older: are there differences in the indication and histopathology compared to other patients?]. / La biopsia renal en pacientes de 65 o más años: ¿existen diferencias en la indicación y en la histopatología respecto al resto de pacientes?

BACKGROUND: Renal biopsy (RB) represents the gold standard for diagnosis of kidney diseases. In this paper we analyse whether the indication of RB and histopathology in patients 65 years or older is different from the other patients. MATERIAL AND METHODS: Retrospective study of 93 native renal biopsies performed in the General Hospital of Segovia in the period 2004-2008. The RB was performed percutaneously under ultrasound guidance in real time, using a 16G automatic needle. RESULTS: Mean age of biopsied patients was 56.89 ± 19 (range 14-89) , and 57% were males. A total of 39RB were performed on people aged 65 years or older. Overall, nephrotic syndrome (NS) is the most common indication of RB, and IgA glomerulonephritis the most common histology. In people ≥ 65 years, acute renal failure (ARF) is the most common indication for RB, and rapidly progressing (crescentic) glomerulonephritis/vasculitis the most detected the diagnosis. When taking age into account, no significant differences in the number of glomeruli obtained by RB or in the number of RB performed on the same patient. CONCLUSIONS: In people 65 years or older, ARF is the main indication of RB and crescentic glomerulonephritis/vasculitis the most frequent diagnosis.

[Estimation of glomerular filtration rate in persons aged 69 years or older: agreement between distinct calculation methods]. / Estimación del filtrado glomerular en personas de 69 años o más: concordancia entre diferentes métodos de cálculo.

MATERIAL: Estimation of glomerular filtration rate (eGFR) is the most widely accepted marker of renal function. Precise calculation is not routinely performed in clinical practice. Several methods have been developed for eGFR: creatinine clearance (CCr) calculation or the use of formulae derived from serum creatinine (sCr). The present study aimed to analyze the agreement between distinct methods of calculating eGFR. MATERIAL AND METHODS: We performed a cross-sectional study between January and April, 2006 in 32 stable elders, aged 69 years or older, evaluated in a general nephrology unit. eGFR was calculated by CCr (considered the gold standard), Cockcroft-Gault (CG) and Modification of Renal Diet in Disease (MDRD) equations. The Mann Whitney U-test, Spearman's correlation coefficient and the Kappa coefficient were used to compare means and determine the concordance between methods. RESULTS: The overall means+/-SD of GFRe for CCr were 36.14+/-16 ml/min (range 11.75-69.6); CG: 37.02+/-16 ml/min (range 13.3-72.3) and MDRD: 45.52+/-16 ml/min (range 19.2-75.36). Variations in eGFR on comparison of methods were CCr and MDRD: -9.37 ml/min (95% CI:-13.85, -4.9); CCr and CG:-2.54 ml/min (95% CI: -6.95, 1.80); MDRD and CG: 9.0 ml/min (95% CI: 5.96, 12). The correlation between the gold standard (CCr) and sCr-derived formulae was r=0.74 for MDRD (P<0.001) and r=0.77 for CG (P<0.001). The Kappa value for CCr and CG was 0.44 and was 0.35 for CCr and MDRD. When patients were classified by stage of chronic renal disease, discrepancies were found according to the method used: stage 5 (eGFR<15 ml/min) was diagnosed in 13.63% with CG while none were diagnosed with stage 5 with MDRD. CONCLUSIONS: In the estimation of the renal function in the elderly, eGFRe levels can differ in the same patient according to the method used: in view of the degree of concordance between CG and CCr, this mathematical formula should be used in preference to MDRD.

[Laboratory manifestations associated with chronic renal failure: what degree of estimated glomerular filtration can be used for its detection in the elderly?]. / Las manifestaciones analíticas asociadas a la insuficiencia renal crónica: ¿a partir de qué grado de filtrado glomerular estimado las detectamos en ancianos?

OBJECTIVE: A classification of chronic kidney disease (CKD) based on stages of glomerular filtration (GF) has recently been developed. Thus, chronic renal failure (CRF) is based on GF <60 ml/min. Our goal was to study the presence of typical manifestations of CRF in elderly individuals with a GF of <60 ml/min (stage 3-5) and to determine the cut-off value at which GF can be used to detect these manifestations. MATERIAL AND METHODS: We performed a cross-sectional study in clinically-stable elderly patients attending the geriatrics and nephrology outpatient department. The estimated GF (GFe) was established with the Cockroft-Gault and abbreviated Modification of Diet in Renal Disease Study (MDRD) formulae. Because these patients had a GF of less than 60 ml/min, they were expected to show the manifestations associated with CRF (anaemia, metabolic acidosis, abnormal bone and mineral metabolism). We evaluated the occurrence of these manifestations and the GF cut-off at which they were detected. To do this, the population was divided into two groups: group A: patients with GFe > or = 30 ml/min (stage 3, N=48); and group B: patients with GFe <30 ml/min (stages 4-5, N=8). RESULTS: Seventy percent of the patients had a GFe (MDRD) <60 ml/min (stage 3-5). Despite reduced GF, these patients did not show the typical manifestations of CRF. Group B showed higher plasmatic levels of creatinine, urea, uric acid, and potassium and required treatment with erythropoietin and calcium salts. CONCLUSIONS: Many elderly people diagnosed with CKD with the current classification do not show manifestations of CRF. Estimation of the GF in elders should be generalized to correctly adjust medication to renal impairment rather than to classify elders into CKD stage.

Disability in instrumental activities of daily living in hemodialysis patients: Influence on quality of life related to health. / Dependencia para las actividades instrumentales de la vida diaria en pacientes en hemodiálisis: influencia sobre la calidad de vida relacionada con la salud.

INTRODUCTION: Instrumental Activities of Daily Life (IADL) requires a higher level of personal autonomy and interaction with the environment than the basic activities of daily life (BADL). Few studies analyze the deficit on IADL. Early detection is important because an early action can delay the evolution of the dependency process. AIM: to know the prevalence of functional deficit in IADL of hemodialysis patients, its relationship with the functional deficit in the BADL and its influence on the health related quality of life (HRQoL). METHODS: Cross-sectional study in 66 patients on HD. Different scales were used: Lawton and Brody (AIVD dependency), Delta (BADL dependency), and COOP-WONCA (HRQOL). Clinical data were collected (age, sex, CKD etiology, months in HD, marital status, employment situation). RESULTS: 80.3% of the patients had some degree of dependence for the IADL (57.5% in moderate/severe degree) and 40.8% for the BADL (9% in moderate/severe degree). There was a correlation between dependence to the BADL and AIVD. Age and employment status influence the dependence on IADL and BADL. Patients with greater dependence on IADL had worse HRQoL (P<.000). The dimensions in which they showed greater differences were "Daily activities", "Social activities" and "Social support". CONCLUSIONS: HD patients are more dependent on IADL than on ADL and with a higher degree of severity and the level of dependence in both types of activities has important influence on HRQoL. Early detection of the occurrence of disability in the realization of IADL can be used to initiate intervention programs that help to prevent, reverse or delay the progression.

Consequences of the implementation of K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease in a population of patients on chronic hemodialysis.

BACKGROUND: After application of K/DOQI recommendations, a large proportion of our patients failed to reach the proposed targets. This study examined the causes of these findings. METHODS: Patients (n=163) were compared in 2 periods (8 months before and after application of K/DOQI guidelines). Serum calcium (Ca), phosphorus (P), parathyroid hormone (PTH) and calcium x phosphate product (Ca x P); mean dialysate Ca content; mean doses of vitamin D; and average prescription of Ca-based phosphate binders and sevelamer in both periods were analyzed. RESULTS: Prescription of Ca salts as phosphate-binding agents decreased and prescription of sevelamer increased in an attempt to maintain serum Ca levels between 8.4 and 9.5 mg/dL post-K/DOQI. Increased serum PTH levels were associated with decreased serum Ca levels (relative risk [RR] = 41.1, p<0.001) and increased serum P levels (RR=6.81, p<0.01). Use of dialysis fluids with Ca content of 2.5 mEq/L was associated with an increased risk of having PTH levels >300 pg/mL (RR=11.4, p<0.003). Vitamin D metabolites had to be discontinued in 26 patients (37.1% of those receiving them from study start) due to hyperphosphoremia or hypercalcemia post-K/DOQI; and serum PTH significantly increased (445.8 +/- 238.2 pg/mL vs. 715.2 +/- 549.5 pg/mL; p<0.001). Ninety-three patients (57%) did not receive vitamin D at study start; in 20 of those (21.5%), vitamin D had to be started post-K/DOQI. CONCLUSIONS: Clinical guidelines do not appear to be sufficient to overcome all difficulties arising in daily management of these patients.

Nephrotic syndrome resulting from focal segmental glomerulosclerosis in a peripheral blood stem cell transplant patient.

We describe the case of a male patient who was diagnosed with acute monoblastic leukemia and received a peripheral stem cell transplantation (PSCT) with peripheral blood hematopoietic progenitors. Because he was in clinical remission with no evidence of chronic graft-versus-host disease (GVHD), immunosuppression was withdrawn, and he developed nephrotic syndrome (NS) months later. A kidney biopsy showed focal segmental glomerulosclerosis (FSGS) as part of the GVHD. Soon after the reintroduction of previous immunosuppressive therapy, we observed a complete remission of the NS.

Emotional distress and health-related quality of life in patients on hemodialysis: the clinical value of COOP-WONCA charts.

BACKGROUND: A significant percentage of patients on hemodialysis (HD) present with affective disorders such as anxiety and/or depression. The purpose of this study was to explore adaptive mixed affective disorders of patients on HD and to analyze the clinical value of a brief health-related quality-of-life (HRQoL) instrument, the COOP-WONCA charts, in our population of HD patient. METHODS: Seventy-five patients (mean age 49.2 years; range 20.1-64.9), who had been on HD for a mean 110 months (range 6.1-364.5 months) were studied. The Beck Depression Inventory (BDI), Hamilton Scale of Depression (HDRS) and Hamilton Scale of Anxiety (HARS) were used. To evaluate patient HRQoL, we used the validated Spanish version of the COOP-WONCA charts. RESULTS: Of the 75 patients studied, 44.0% (BDI) and 53.4% (HDRS) had some depressive symptoms which were moderate-severe in 14.7% (BDI) and in 22.7% (HDRS). Anxiety symptoms were observed in 46.6% of the patients (13.3% were of moderate-severe degree). There was a high level of association between both depression scales (BDI and HDRS) (r=0.70; p<0.001), as well as between both scales and the HARS (HDRS, r=0.82; p<0.001; BDI, r=0.53; p<0.001). The most affected dimensions of the COOP-WONCA charts were "Physical fitness" and "Overall health," whereas the least affected were "Social activities" and "Daily activities." The global score of the COOP-WONCA charts was associated with the presence of depressive (BDI, r=0.64, and HDRS, r=0.75; p<0.001) and anxiety symptoms (HARS, r=0.52; p<0.001). A score of >or= 3 corresponding to the dimension "Feelings" on the COOP-WONCA charts allowed the detection of 81.8% of the patients with clinically significant depressive symptoms (BDI >18), with a sensitivity of 96.8% and a specificity of 75% for this cutoff point. CONCLUSIONS: A high percentage of patients on HD present with mixed emotional disorders (anxiety and/or depression); a good correlation is observed between HRQoL and the levels of anxiety and depression in these patients; and measuring HRQoL with the COOP-WONCA charts may help diagnose such problems.

Strategies to increase patient safety in Hemodialysis: Application of the modal analysis system of errors and effects (FEMA system). / Estrategias para aumentar la seguridad del paciente en hemodiálisis: Aplicación del sistema de análisis modal de fallos y efectos (sistema AMFE).

BACKGROUND: Haemodialysis (HD) patients are a high-risk population group. For these patients, an error could have catastrophic consequences. Therefore, systems that ensure the safety of these patients in an environment with high technology and great interaction of the human factor is a requirement. OBJECTIVES: To show a systematic working approach, reproducible in any HD unit, which consists of recording the complications and errors that occurred during the HD session; defining which of those complications could be considered adverse event (AE), and therefore preventable; and carrying out a systematic analysis of them, as well as of underlying real or potential errors, evaluating their severity, frequency and detection; as well as establishing priorities for action (Failure Mode and Effects Analysis system [FMEA systems]). METHODS: Retrospective analysis of the graphs of all HD sessions performed during one month (October 2015) on 97 patients, analysing all recorded complications. The consideration of these complications as AEs was based on a consensus among 13 health professionals and 2 patients. The severity, frequency and detection of each AE was evaluated by the FMEA system. RESULTS: We analysed 1303 HD treatments in 97 patients. A total of 383 complications (1 every 3.4 HD treatments) were recorded. Approximately 87.9% of them was deemed AEs and 23.7% complications related with patients' underlying pathology. There was one AE every 3.8 HD treatments. Hypertension and hypotension were the most frequent AEs (42.7 and 27.5% of all AEs recorded, respectively). Vascular-access related AEs were one every 68.5 HD treatments. A total of 21 errors (1 every 62 HD treatments), mainly related to the HD technique and to the administration of prescribed medication, were registered. The highest risk priority number, according to the FMEA, corresponded to errors related to patient body weight; dysfunction/rupture of the catheter; and needle extravasation. CONCLUSIONS: HD complications are frequent. Consideration of some of them as AEs could improve safety by facilitating the implementation of preventive measures. The application of the FMEA system allows stratifying real and potential errors in dialysis units and acting with the appropriate degree of urgency, developing and implementing the necessary preventive and improvement measures.

Assessing value-based health care delivery for haemodialysis.

RATIONALE, AIMS AND OBJECTIVES: Disparities in haemodialysis outcomes among centres have been well-documented. Besides, attempts to assess haemodialysis results have been based on non-comprehensive methodologies. This study aimed to develop a comprehensive methodology for assessing haemodialysis centres, based on the value of health care. The value of health care is defined as the patient benefit from a specific medical intervention per monetary unit invested (Value = Patient Benefit/Cost). This study assessed the value of health care and ranked different haemodialysis centres. METHOD: A nephrology quality management group identified the criteria for the assessment. An expert group composed of stakeholders (patients, clinicians and managers) agreed on the weighting of each variable, considering values and preferences. Multi-criteria methodology was used to analyse the data. Four criteria and their weights were identified: evidence-based clinical performance measures = 43 points; yearly mortality = 27 points; patient satisfaction = 13 points; and health-related quality of life = 17 points (100-point scale). Evidence-based clinical performance measures included five sub-criteria, with respective weights, including: dialysis adequacy; haemoglobin concentration; mineral and bone disorders; type of vascular access; and hospitalization rate. The patient benefit was determined from co-morbidity-adjusted results and corresponding weights. The cost of each centre was calculated as the average amount expended per patient per year. RESULTS: The study was conducted in five centres (1-5). After adjusting for co-morbidity, value of health care was calculated, and the centres were ranked. A multi-way sensitivity analysis that considered different weights (10-60% changes) and costs (changes of 10% in direct and 30% in allocated costs) showed that the methodology was robust. The rankings: 4-5-3-2-1 and 4-3-5-2-1 were observed in 62.21% and 21.55%, respectively, of simulations, when weights were varied by 60%. CONCLUSIONS: Value assessments may integrate divergent stakeholder perceptions, create a context for improvement and aid in policy-making decisions.

Obstructive ARF caused by an inflammatory abdominal aortic aneurysm.

Inflammatory abdominal aortic aneurysms are rare entities characterized by dense fibrosis typically enveloping the aortic wall and adjacent structures with distinctive clinical features that differentiate them from typical atherosclerotic aneurysms. The inflammatory process can involve the renal excretory pathways, causing ureteral obstruction in 20% of cases. The authors report 2 cases of complete obstructive anuria secondary to inflammatory aneurysms and discuss the most appropriate management for these situations of hydronephrosis. Surgical repair of the aneurysm usually leads to regression of the inflammatory reaction.

Health-related quality of life of family caregivers of dialysis patients.

BACKGROUND: This study aimed to evaluate the health-related quality of life (HRQOL) and burden on family caregivers of chronic dialysis patients and to analyze which factors were associated with it. METHODS: A cross-sectional multicentric study was carried out with 221 patient/caregiver pairs. General population Short Form 36 (SF-36) norms were used to estimate gender and age standardized physical component summary (PCS) and mental component summary (MCS) scores. The Duke-UNC Functional Social Support Questionnaire (FSS), the Zarit Burden Interview (ZBI), and sociodemographic and clinical data were also collected. RESULTS: The PCS and MCS of caregivers were slightly worse than that of the Spanish population. Multiple regression analysis showed that: (1) lower PCS was associated with younger age and higher ZBI of the caregiver (R2=0.15); (2) lower MCS was associated with higher ZBI and lower FSS of the caregiver, and lower MCS of the patient (R2=0.29); (3) higher ZBI was associated with lower FSS, PCS and MCS of the caregiver, and to older age and lower PCS and MCS of the patient (R2=0.49). Of caregivers 28.3% had a MCS < or = 42; logistic regression analysis showed that a MCS < or = 42 was associated to higher ZBI and lower FSS scores (p<0.001). CONCLUSIONS: The HRQOL of dialysis patient family caregivers is slightly worse than that of the Spanish population of the same age and gender. Younger family members, who are the primary carers of older dialysis patients with poor HRQOL, experienced a higher burden, had a worse HRQOL and had a higher risk of clinical depression; this was worse if low social support was perceived.

Different evaluations of the health related quality of life in dialysis patients.

BACKGROUND: Sometimes patients on dialysis treatment cannot express their health-related quality of life (HRQoL); and therefore, it is necessary to use the assessment made by their carers. The purpose of this study was to evaluate the agreement between dialysis patients' HRQoL and the assessment made by their carers, and to investigate which variables were associated with the differences found. METHODS: Two hundred and twenty-two pairs of patients and carers were selected from 14 dialysis units. Patients' HRQoL was evaluated by the patients themselves and by their family carer (FAM), nurse (NUR) and physician (PH) using the Karnofsky scale (KS) and the EuroQOL5D (EQ5D) scale. Patients and their family carers answered the Medical Outcome Survey 36-Item Short Form Health Survey (SF-36), and the family carers answered the Zarit burden interview. Physicians scored the patients' comorbidity index and nurses evaluated the Barthel index (BI). RESULTS: The intraclass correlation coefficients (ICC) between the ratings provided by patients and their carers were: KS: 0.80(FAM), 0.76(NUR) and 0.62(PH); EQ5D: 0.42(FAM), 0.48(NUR) and 0.29(PH). The agreement between the EQ5D dimension scores varied from moderate for mobility and self-care to insignificant for pain and anxiety/depression. The variables associated to the size of the differences found were the Zarit burden interview score and the mental component score (MCS) (SF-36) of the carer, the physical component score (PCS) (SF-36), the BI score and patient comorbidity, and the physician's age and experience. CONCLUSIONS: Family carers and health care providers of dialysis patients are reasonably aware of the patient's level of function and well being and can be useful sources of proxy HRQoL information. Nevertheless, discrepancies can occur, depending in part on the different characteristics of patients and their caregivers.

Predictive value of troponin T levels for ischemic heart disease and mortality in patients on hemodialysis.

BACKGROUND: Serum cardiac troponin T (cTnT) levels are elevated in a high percentage of hemodialysis (HD) patients and as a result, they have been considered low specificity for ischemic heart disease (IHD). Recently, several authors have indicated the value of cTnT as a marker of IHD and left ventricular hypertrophy (LVH), as well as a mortality predictor. We try to establish the value of cTnT as an IHD marker and a mortality predictor in our patients on HD. SUBJECTS AND METHODS: Fifty-eight HD patients were prospectively studied from October 2000 to April 2002. Clinical and laboratory evaluations, including cTnT, C-reactive protein (CRP) and N terminal fragment of brain natriuretic peptide (pro-BNP) levels, were performed at the beginning of the study and at 6 and 18 months. HD patients with two or more cTnT measurements were classified in four groups: group I with all levels <0.04 ng/mL; group II with all levels between 0.04 and 0.1 ng/mL; group III with all levels >/=0.1 ng/mL; and group IV including those patients in whom cTnT levels increased during follow-up, switching from one group to another (from <0.04 to 0.04-0.1 or from 0.4-0.1 to >0.1 ng/mL). RESULTS: Mean and median cTnT levels were 0.07 +/- 0.09 and 0.04 ng/mL, respectively. Of clinically stable dialysis patients 15.5% had cTnT levels >0.1 ng/mL. In the stepwise multiple regression analysis, the subset of variables best explaining cTnT levels were pro-BNP levels, history of IHD and residual diuresis volume (r2=0.45). The analysis of variance (ANOVA linear regression analysis for repeated measures) showed an increase in cTnT and pro-BNP levels (significantly from 18 months). cTnT and CPR levels were the only variables predicting mortality (Cox's proportional hazards model). When patients were analyzed according to cTnT groups during the follow-up, no patient in group I (n=23) and only one patient in group II (n=11) experienced IHD; three patients in group III (n=12) had been diagnosed with IHD at the start of the study, and five patients in group IV (n=16) developed de novo IHD. CONCLUSIONS: Of patients on HD 15.5% had cTnT levels >0.1 ng/mL. The main variables associated with cTnT levels were IHD, pro-BNP levels and residual diuresis. cTnT and pro-BNP levels tended to increase with time on dialysis. cTnT together with CRP levels were the best mortality predictors in our HD patients. The stability over time of cTnT levels within normal ranges (<0.1 ng/mL) suggests a very low risk of subsequent IHD development, while a progressive and sustained increase in cTnT levels suggests a high risk of IHD development.

Inflammation and malnutrition as predictors of mortality in patients on hemodialysis.

BACKGROUND: Low albumin and high C-reactive protein (CRP) are significant predictors of mortality in hemodialysis (HD) patients. Although, classically, hypoalbuminemia has been attributed to malnutrition, inflammation can also predict the serum albumin concentration in dialysis patients. OBJECTIVE: To establish the influence of nutritional status and inflammation on mortality in HD patients. METHODS: A cross-sectional study was conducted in 64 patients (35 males; 9 diabetics; mean age 64 +/- 12 years), who had been on HD for 64 +/- 58 months. Nutritional status was assessed from estimated protein caloric intake, dietary recall, anthropometric and biochemical parameters, and serum levels of insulin-like growth factor-1 (IGF-1). CRP was used as a marker of inflammation. Comorbidity was measured using a modified M. Charlson index. The dialysis doses (Kt/V) and protein catabolic rate (PCR) were measured and standardized for actual and ideal body weight. The incidence and causes of death were recorded during the two-year follow-up. RESULTS: During the follow-up period, 18 patients died and 11 were withdrawn from the study after receiving a renal transplant. In multivariante analysis (Cox proportional hazards model), total comorbidity and the levels of CRP and hematocrit (increased) and IGF-1 (decreased) were independent predictors of mortality. CONCLUSIONS: Inflammation, as measured by CRP, and malnutrition, as measured by IGF-1 levels, are associated with mid-term mortality in HD patients. High hematocrit was an independent risk factor for mortality. Comorbidity, measured by disease and the degree of functional impairment, was a good predictor of mortality.

Estrategias para aumentar la seguridad del paciente en hemodiálisis: Aplicación del sistema de análisis modal de fallos y efectos (sistema AMFE) / Strategies to increase patient safety in Hemodialysis: Application of the modal analysis system of errors and effects (FEMA system)

Antecedentes: La población en hemodiálisis (HD) es de alto riesgo. En estos pacientes un fallo puede tener consecuencias catastróficas, por lo que son necesarios sistemas que garanticen su seguridad en un entorno con alta tecnología y gran interacción del factor humano. Objetivos: Mostrar una sistemática de trabajo, reproducible en cualquier unidad de HD, que consiste en registrar las complicaciones y fallos ocurridos durante la sesión, definir cuáles de estas complicaciones podrían ser consideradas eventos adversos (EA) y, por tanto, prevenibles y realizar un análisis sistemático tanto de ellos como de los fallos reales o potenciales subyacentes, evaluando su gravedad, frecuencia y detección, y estableciendo prioridades de actuación (sistema de análisis modal de fallos y efectos [AMFE]). Métodos: Examen retrospectivo de las gráficas de diálisis de todas las sesiones practicadas durante un mes (octubre de 2015) en 97 pacientes, y análisis de las complicaciones registradas. La consideración de estas complicaciones como EA se basó en el consenso entre 13 profesionales y 2 pacientes. Se valoró la severidad, frecuencia y detección de cada fallo real o potencial mediante el sistema AMFE. Resultados: Se practicaron 1.303 sesiones de HD en 97 pacientes en las que se registraron un total de 383 complicaciones (1 cada 3,4 tratamientos). De ellas, el 87,9% fueron consideradas EA y el 23,7% complicaciones relacionadas con la enfermedad de base. Se detectó un EA cada 3,8 tratamientos. Los EA más frecuentes fueron la hipertensión y la hipotensión (42,7 y 27,5% del total de EA registrados, respectivamente). Los EA relacionados con el acceso vascular fueron uno de cada 68,5 tratamientos. Se registraron un total de 21 fallos en la asistencia (1 cada 62 tratamientos), los cuales estaban relacionados con fallos en la aplicación de la técnica y en la administración de la medicación. El mayor número de prioridad de riesgo lo obtuvieron los fallos relacionados con errores en el peso, disfunción o rotura del catéter y salida de agujas. Conclusiones: Las complicaciones en HD son frecuentes y la consideración de algunas de ellas como EA podría mejorar la seguridad en la asistencia, al poner en marcha medidas preventivas. La implementación del sistema AMFE permite estratificar y priorizar los posibles fallos de las unidades de diálisis, y actuar con mayor o menor premura, desarrollando las acciones de mejora necesarias (AU)

Background: Haemodialysis (HD) patients are a high-risk population group. For these patients, an error could have catastrophic consequences. Therefore, systems that ensure the safety of these patients in an environment with high technology and great interaction of the human factor is a requirement. Objectives: To show a systematic working approach, reproducible in any HD unit, which consists of recording the complications and errors that occurred during the HD session; defining which of those complications could be considered adverse event (AE), and therefore preventable; and carrying out a systematic analysis of them, as well as of underlying real or potential errors, evaluating their severity, frequency and detection; as well as establishing priorities for action (Failure Mode and Effects Analysis system [FMEA systems]). Methods: Retrospective analysis of the graphs of all HD sessions performed during one month (October 2015) on 97 patients, analysing all recorded complications. The consideration of these complications as AEs was based on a consensus among 13 health professionals and 2 patients. The severity, frequency and detection of each AE was evaluated by the FMEA system. Results: We analysed 1303 HD treatments in 97 patients. A total of 383 complications (1 every 3.4 HD treatments) were recorded. Approximately 87.9% of them was deemed AEs and 23.7% complications related with patients'underlying pathology. There was one AE every 3.8 HD treatments. Hypertension and hypotension were the most frequent AEs (42.7 and 27.5% of all AEs recorded, respectively). Vascular-access related AEs were one every 68.5 HD treatments. A total of 21 errors (1 every 62 HD treatments), mainly related to the HD technique and to the administration of prescribed medication, were registered. The highest risk priority number, according to the FMEA, corresponded to errors related to patient body weight; dysfunction/rupture of the catheter; and needle extravasation. Conclusions: HD complications are frequent. Consideration of some of them as AEs could improve safety by facilitating the implementation of preventive measures. The application of the FMEA system allows stratifying real and potential errors in dialysis units and acting with the appropriate degree of urgency, developing and implementing the necessary preventive and improvement measures (AU)

Outcomes weighting for comprehensive haemodialysis centre assessment.

BACKGROUND: At present, there is no adequate system available for evaluating dialysis centres. OBJECTIVES: To construct an overall haemodialysis results weighting system, acceptable to the different stakeholders involved which allows the comparison of centres using a compound marker. METHOD: The Quality Management Work Group of the Spanish Society of Nephrology (WG) established a set of preselected indicators. A Focus Group, independent of the WG, was established. It was made up of nine individuals: three patients, three clinicians and three clinical managers, who assessed these indicators using an approved methodology and established the selected indicators. Finally, the indicators were weighted through three weighting stages, each separated by two debate periods, which involved the distribution of 100 points between each variable, according to the personal assessment and the debate sustained. RESULTS: The clinical results included: haemodialysis doses, anaemia, plasma calcium and phosphorus, type of vascular access, and hospitalisation days. The weighting given to each variable following the third weighting process, expressed as an average of all the factors, was as follows: clinical results 38.9; annual mortality 25.0; satisfaction with the centre 12.2; health-related quality of life 15.6; and cost 8.3 (total 100). CONCLUSIONS: The weighting structure covers relevant and overall results and includes the opinion of all stakeholders involved; all of which will increase its acceptability and widespread use and contribute to the analysis of the value produced by the centres and the improvement of the results.