Factors influencing access to education, decision making, and receipt of preferred dialysis modality in unplanned dialysis start patients.

OBJECTIVES: Unplanned dialysis start (UPS) leads to worse clinical outcomes than planned start, and only a minority of patients ever receive education on this topic and are able to make a modality choice, particularly for home dialysis. This study aimed to determine the predictive factors for patients receiving education, making a decision, and receiving their preferred modality choice in UPS patients following a UPS educational program (UPS-EP). METHODS: The Offering Patients Therapy Options in Unplanned Start (OPTiONS) study examined the impact of the implementation of a specific UPS-EP, including decision support tools and pathway improvement on dialysis modality choice. Linear regression models were used to examine the factors predicting three key steps: referral and receipt of UPS-EP, modality decision making, and actual delivery of preferred modality choice. A simple economic assessment was performed to examine the potential benefit of implementing UPS-EP in terms of dialysis costs. RESULTS: The majority of UPS patients could receive UPS-EP (214/270 patients) and were able to make a decision (177/214), although not all patients received their preferred choice (159/177). Regression analysis demonstrated that the initial dialysis modality was a predictive factor for referral and receipt of UPS-EP and modality decision making. In contrast, age was a predictor for referral and receipt of UPS-EP only, and comorbidity was not a predictor for any step, except for myocardial infarction, which was a weak predictor for lower likelihood of receiving preferred modality. Country practices predicted UPS-EP receipt and decision making. Economic analysis demonstrated the potential benefit of UPS-EP implementation because dialysis modality costs were associated with modality distribution driven by patient preference. CONCLUSION: Education and decision support can allow UPS patients to understand their options and choose dialysis modality, and attention needs to be focused on ensuring equity of access to educational programs, especially for the elderly. Physician practice and culture across units/countries is an important predictor of UPS patient management and modality choice independent of patient-related factors. Additional work is required to understand and improve patient pathways to ensure that modality preference is enacted. There appears to be a cost benefit of delivering education, supporting choice, and ensuring that the choice is enacted in UPS patients.

Review of predialysis education programs: a need for standardization.

To make an informed decision on renal replacement therapy, patients should receive education about dialysis options in a structured program covering all modalities. Many patients do not receive such education, and there is disparity in the information they receive. This review aims to compile evidence on effective components of predialysis education programs as related to modality choice and outcomes. PubMed MEDLINE, Cochrane Library, and Ovid searches (from January 1, 1995 to December 31, 2013) with the main search terms of "predialysis", "peritoneal dialysis", "home dialysis", "education", "information", and "decision" were performed. Of the 1,005 articles returned from the initial search, 110 were given full text reviews as they potentially met inclusion criteria (for example, they included adults or predialysis patients, or the details of an education program were reported). Only 29 out of the 110 studies met inclusion criteria. Ten out of 13 studies using a comparative design, showed an increase in home dialysis choice after predialysis education. Descriptions of the educational process varied and included individual and group education, multidisciplinary intervention, and varying duration and frequency of sessions. Problem-solving group sessions seem to be an effective component for enhancing the proportion of home dialysis choice. Evidence is lacking for many components, such as timing and staff competencies. There is a need for a standardized approach to evaluate the effect of predialysis educational interventions.

Pharmacovigilance as a tool for safety and monitoring: a review of general issues and the specific challenges with end-stage renal failure patients.

Pharmacovigilance is instrumental in helping to ensure patient safety for both newly released drugs and those that are well established in the market. However, while pharmacovigilance procedures are strictly regulated in the clinical trial setting, post-marketing adverse event reporting is not well implemented or enforced. As such, the underreporting of adverse events, in relation to drugs that are on the market, is estimated to be in the region of 90%. The identification of drug safety issues in patients with complex diseases and extensive comorbidities is therefore particularly challenging. Dialysis patients - those with end-stage renal disease and often other comorbidities such as diabetes, hypertension, and cardiovascular disease - are a population with significant treatment challenges. Patients receive dialysis using complex medical devices (eg, a peritoneal dialysis home cycler) and also receive a range of pharmaceutical agents as part of dialysis itself (eg, peritoneal dialysis solutions). Many of the pharmaceutical agents used to treat these patients have been developed in populations without these complications and, therefore, an extensive knowledge of potential problems and contraindications in the dialysis population is lacking. It is important that the nephrology community understands the concept of pharmacovigilance - the pharmacologic science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly long-term and short-term side effects, of medicines. Health care professionals (HCPs) and providers, pharmaceutical companies, global regulatory agencies, and the patients themselves all play unique and critical roles in this process. This review defines the science of pharmacovigilance and the process of adverse event reporting, highlights the new directions that pharmacovigilance has taken, and provides insight for HCPs managing dialysis patients into the important role that they play in helping to shape the understanding of a drug's safety profile in order to continually enhance patient safety.

Sodium-lithium countertransport and the Gly460-->Trp alpha-adducin polymorphism in essential hypertension.

A polymorphism of the alpha-subunit of adducin, Gly460-->Trp, may affect membrane ion transport and be associated with human EH (essential hypertension). The alpha-adducin Gly460-->Trp polymorphism was determined in 242 NC (normal controls) and 73 patients with EH and was related to the membrane ion transport marker in EH, erythrocyte Na/LiCT (sodium-lithium countertransport), in a subgroup of these subjects. The Km for external sodium was lower in patients with EH than NC. The Km of the Trp allele was lower than with the Gly/Gly genotype [NC, 105+/-6 compared with 88+/-5 mmol Na/l respectively (P=0.05); patients with EH, 76+/-5 compared with 64+/-4 mmol Na/l respectively (P=0.06)]. The Km was lower in patients with EH than NC for any adducin genotype. Thiol alkylation with NEM (N-ethylmaleimide) caused a decrease in Km in NC, but not in patients with EH. With a Trp allele, NEM lowered Km less in NC (-20 compared with -35) and increased it in patients with EH (+24 compared with +3; P=0.007 for genotype effect). Thiol alkylation with NEM caused an increase in Vmax in patients with EH but not in NC. With a Trp allele, NEM increased Vmax substantially in patients with EH (+0.12 compared with +0.03) but did not cause a decrease in NC (+0.02 compared with -0.06; P=0.007 for genotype effect). In conclusion, the Gly460-->Trp polymorphism of alpha-adducin modifies the kinetics of Na/LiCT. The effect of this genotype is different in patients with EH compared with NC and it does not explain the abnormal kinetics in patients with EH. The Trp allele was not associated with disease in the population studied. Several cytoskeletal proteins may interact with adducin in the overall phenotype of EH.

Rapid diagnosis of peritonitis in peritoneal dialysis patients.

BACKGROUND: Peritonitis is the major complication of peritoneal dialysis (PD) and has acute morbidity and resources implications. Episodes of peritonitis are associated with higher risk of peritoneal membrane failure. Rapid diagnosis of peritonitis would allow early antibiotic commencement with potential benefits of reduced need for in-patient care and dialysis modality change. This study examined the utility of a rapid peritonitis diagnosis method (Periscreen). METHODS: This was a prospective study in a single unit and included all PD patients presenting with symptoms or signs of peritonitis over 12 months. In each clinical circumstance in which the diagnosis or exclusion of peritonitis was required and in follow-up peritonitis cases, PD fluid was sent for standard laboratory analysis but also tested using the Periscreen strip. The relationship between this rapid diagnostic strip and standard laboratory methods for determination of PD fluid neutrophil count was determined. RESULTS: This study found the Periscreen strip easy to use and interpret. All 17 episodes of peritonitis (defined by ISPD criteria) were detected and results of the strip correlated closely with the laboratory cell count. In this study sensitivity of the Periscreen was 100% and specificity was 98%, positive predictive value was 95.6% and negative predictive value was 100%. Results were equally good in glucose containing fluids and icodextrin. CONCLUSIONS: Periscreen is a sensitive, specific rapid tool for the presumptive diagnosis of peritonitis in PD patients used at the "point of care". Results correlated with the laboratory white cell count, a test that takes longer to perform. Widespread use in PD would aid in the early recognition and treatment of peritonitis.