Item Development and Face Validity of the Rheumatoid Arthritis Patient Priorities in Pharmacological Interventions Outcome Measures

© 2015, Springer International Publishing Switzerland. Background: The assessment of rheumatoid arthritis (RA) is dominated by core sets and indices that have been developed by RA professionals. Previous research developed a set of eight priority treatment outcomes generated by patients to complement the professionally developed core sets for RA. Objective: This study aimed to facilitate quantitative measurement of these outcomes. Methods: Two consultation meetings with patient research partners diagnosed with RA (n=18) were held to identify face validity in existing instruments (Phase 1) at the Bristol Royal Infirmary. Where validated measures did not exist, new numerical rating scales (NRS) were constructed and discussed at two focus groups with patients diagnosed with RA (n=8) at the Bristol Royal Infirmary and the Royal National Hospital for Rheumatic Diseases (Phase 2). Feedback on the stem question, time frame, anchors and layout was recorded and transcribed verbatim. Results: Of the eight priorities, existing NRS for pain, activities of daily living and fatigue were voted as acceptable (Phase 1), but new NRS were required for five priorities. The partners strongly recommended that the three separate domains of severity, effect and ability to cope in each measurement area be assessed, as in the existing validated fatigue NRS. Focus group participants (Phase 2) made significant contributions to the phrasing of questions, for example how to ensure ‘mobility’ could be uniformly understood and how changes in valued activities be judged appropriately. Conclusion: Through extensive patient feedback, 24 NRS were constructed based on priorities identified by patients and encompassing domains where existing questionnaires contain many more items and do not address three important concepts endorsed by patients: severity, effect and coping. The Rheumatoid Arthritis Patient Priorities in Pharmacological Interventions patient-reported outcome measures are now ready for the evaluation of comprehension, construct validity and sensitivity through an observational study

Renal replacement therapy in Sweden

Objective: The Swedish Registry for Active Treatment of Uraemia (SRAU) was founded in 1991 with the objective of documenting demographic data on patients treated for end-stage renal disease (ESRD). The aim of this study was to describe the prevalence, incidence, comorbidity risk factors and survival of patients with ESRD who underwent dialysis treatment and/or kidney transplantation in Sweden between 1991 and 2002. Material and Methods: All dialysis and transplant units (n=65) presently report to the SRAU and almost all patients are reported and followed until death. Results: The prevalence of patients on dialysis and transplantation, being 750 per million population (PMP), has increased by 75% in 12 years. The recent annual rise is approximate to3% (200 patients). The incidence has been stable since 1997 at approximate to125 patients PMP. In 2002, there were 1113 new patients, the majority of whom were aged greater than or equal to65 years. Their original kidney disease was most often diabetic nephropathy (23.7%), with nephrosclerosis (19.0%) being the second most common disease. The total number of renal transplantations performed has decreased to some extent. The overall 5-year patient survival rate was 23.1% in patients on dialysis and 85.5% after kidney transplantation. The major cause of death was cardiovascular disease (48%) and an increasing frequency of malignancy after transplantation (26%) was noted. Conclusion: The prevalence of ESRD has nearly doubled since 1990 and the number of new patients being referred for dialysis has increased. These patients are becoming older, with a large proportion having non-renal complicating diseases. Survival after transplantation was excellent. The shortage of cadaveric donors in Sweden in recent years and increasing mortality from malignant disease after transplantation are issues of great concern

A randomized controlled trial of haemoglobin normalization with epoetin alfa in pre-dialysis and dialysis patients

Background. Partial correction of renal anaemia with erythropoietin improves quality of life (QoL). We aimed to examine if normalization of haemoglobin with epoetin alfa in pre-dialysis and dialysis patients further improves QoL and is safe. Methods. 416 Scandinavian patients with renal anaemia [pre-dialysis, haemodialysis (HD) and peritoneal dialysis patients] were randomized to reach a normal haemoglobin of 135-160 g/l (n = 216) or a subnormal haemoglobin of 90-120 g/l (n = 200) with or without epoetin alfa. Study duration was 48-76 weeks. QoL was measured using Kidney Disease Questionnaires in 253 Swedish dialysis patients. Safety was examined in all patients. Results. QoL improved, measured as a decrease in physical symptoms (P = 0.02), fatigue (P = 0.05), depression (P = 0.01) and frustration (P = 0.05) in the Swedish dialysis patients when haemoglobin was normalized. In pre-dialysis patients, diastolic blood pressure was higher in the normal compared with the subnormal haemoglobin group after 48 weeks. However, the progression rate of chronic renal failure was comparable. In the normal haemoglobin group (N-Hb), 51% had at least one serious adverse event compared with 49% in the subnormal haemoglobin group (S-Hb) (P = 0.32). The incidence of thrombovascular events and vascular access thrombosis in HD patients did not differ. The mortality rate was 13.4% in the N-Hb group and 13.5% in the S-Hb group (P = 0.98). Mortality decreased with increasing mean haemoglobin in both groups. Conclusions. Normalization of haemoglobin improved QoL in the subgroup of dialysis patients, appears to be safe and can be considered in many patients with end-stage renal disease

Effect of Froude Number on the Turbulent Wall Jet in Coflow Stream

Sixth Conference on Design and Modeling of Mechanical Systems (CMSM 2015), Hammamet, TUNISIA, MAR 23-25, 2015International audienceThe influence of the coflow velocity ratio on the behavior of a non isothermal turbulent wall jet has been determined numerically. The numerical resolution of the governing equations is carried out using a finite difference method. Turbulence modeling is performed by a modified low-Reynolds number k-epsilon model. In this work, we are interested in the study of the effect of the coflow stream on the behavior of the dynamic and thermal properties of the wall jet subjected to a constant temperature. A comparison with a simple wall jet is carried out. Further, we will examine the influence of the Froude number on the wall jet emerging in a coflow stream

Biocompatibility and tolerability of a purely bicarbonate-buffered peritoneal dialysis solution.

Contains fulltext : 80497.pdf (publisher's version ) (Open Access)BACKGROUND: Novel peritoneal dialysis solutions are characterized by a minimal content of glucose degradation products and a neutral pH. Many studies have shown the biocompatibility of neutral lactate-buffered solutions; however, until now, the effect of purely bicarbonate-buffered solutions has not been intensively studied in vivo. METHODS: This study was an open label, prospective, crossover multicenter trial to investigate the biocompatibility of a purely bicarbonate-buffered solution (bicPDF) by measuring biocompatibility parameters such as cancer antigen 125 (CA125) in peritoneal effluent. 55 patients were enrolled in the study. After a 2-week run-in phase, 53 patients could be randomized into 2 groups, starting with either standard lactate-buffered peritoneal dialysis fluid (SPDF) for 12 weeks (phase 1) and then switching to bicPDF for 12 weeks (phase 2), or vice versa. Overnight peritoneal effluents were collected at baseline and at the end of phases 1 and 2 and were tested for CA125, hyaluronic acid, vascular endothelial growth factor (VEGF), tumor necrosis factor-alpha (TNF-alpha), interleukin 6 (IL-6), interferon gamma (IFNgamma), and transforming growth factor-beta(1) (TGF-beta1). Total ultrafiltration and residual renal function were also assessed. At the end of the study, pain during fluid exchange and dwell was evaluated using special questionnaires. RESULTS: 34 patients completed the study; 27 of them provided data for analysis of the biocompatibility parameters. CA125 levels in overnight effluent were significantly higher with bicPDF (61.9 +/- 33.2 U/L) than with SPDF (18.6 +/- 18.2 U/L, p < 0.001). Hyaluronic acid levels were significantly lower after the use of bicPDF (185.0 +/- 119.6 ng/mL) than after SPDF (257.4 +/- 174.0 ng/mL, p = 0.013). Both TNF-alpha and TGF-beta1 showed higher levels with the use of bicPDF than with SPDF. No differences were observed for IL-6, VEGF, or IFNgamma levels. We observed an improvement in the glomerular filtration rate with the use of bicPDF but no differences were observed for total fluid loss. Pain scores could be analyzed in 23 patients: there was no difference between the solutions. CONCLUSIONS: The use of a purely bicarbonate-buffered low-glucose degradation product solution significantly changes most of the peritoneal effluent markers measured, suggesting an improvement in peritoneal membrane integrity. Additionally, it seems to have a positive effect on residual renal function