Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial.

Background: The evidence base regarding the safety of intravenous (IV) iron therapy in patients with chronic kidney disease (CKD) is incomplete and largely based on small studies of relatively short duration. Methods: FIND-CKD (ClinicalTrials.gov number NCT00994318) was a 1-year, open-label, multicenter, prospective study of patients with nondialysis-dependent CKD, anemia and iron deficiency randomized (1:1:2) to IV ferric carboxymaltose (FCM), targeting higher (400-600 µg/L) or lower (100-200 µg/L) ferritin, or oral iron. A post hoc analysis of adverse event rates per 100 patient-years was performed to assess the safety of FCM versus oral iron over an extended period. Results: The safety population included 616 patients. The incidence of one or more adverse events was 91.0, 100.0 and 105.0 per 100 patient-years in the high ferritin FCM, low ferritin FCM and oral iron groups, respectively. The incidence of adverse events with a suspected relation to study drug was 15.9, 17.8 and 36.7 per 100 patient-years in the three groups; for serious adverse events, the incidence was 28.2, 27.9 and 24.3 per 100 patient-years. The incidence of cardiac disorders and infections was similar between groups. At least one ferritin level ≥800 µg/L occurred in 26.6% of high ferritin FCM patients, with no associated increase in adverse events. No patient with ferritin ≥800 µg/L discontinued the study drug due to adverse events. Estimated glomerular filtration rate remained the stable in all groups. Conclusions: These results further support the conclusion that correction of iron deficiency anemia with IV FCM is safe in patients with nondialysis-dependent CKD

Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial

Background: Short-term treatment for people with type 2 diabetes using a low dose of the selective endothelin A receptor antagonist atrasentan reduces albuminuria without causing significant sodium retention. We report the long-term effects of treatment with atrasentan on major renal outcomes. Methods: We did this double-blind, randomised, placebo-controlled trial at 689 sites in 41 countries. We enrolled adults aged 18–85 years with type 2 diabetes, estimated glomerular filtration rate (eGFR)25–75 mL/min per 1·73 m 2 of body surface area, and a urine albumin-to-creatinine ratio (UACR)of 300–5000 mg/g who had received maximum labelled or tolerated renin–angiotensin system inhibition for at least 4 weeks. Participants were given atrasentan 0·75 mg orally daily during an enrichment period before random group assignment. Those with a UACR decrease of at least 30% with no substantial fluid retention during the enrichment period (responders)were included in the double-blind treatment period. Responders were randomly assigned to receive either atrasentan 0·75 mg orally daily or placebo. All patients and investigators were masked to treatment assignment. The primary endpoint was a composite of doubling of serum creatinine (sustained for ≥30 days)or end-stage kidney disease (eGFR <15 mL/min per 1·73 m 2 sustained for ≥90 days, chronic dialysis for ≥90 days, kidney transplantation, or death from kidney failure)in the intention-to-treat population of all responders. Safety was assessed in all patients who received at least one dose of their assigned study treatment. The study is registered with ClinicalTrials.gov, number NCT01858532. Findings: Between May 17, 2013, and July 13, 2017, 11 087 patients were screened; 5117 entered the enrichment period, and 4711 completed the enrichment period. Of these, 2648 patients were responders and were randomly assigned to the atrasentan group (n=1325)or placebo group (n=1323). Median follow-up was 2·2 years (IQR 1·4–2·9). 79 (6·0%)of 1325 patients in the atrasentan group and 105 (7·9%)of 1323 in the placebo group had a primary composite renal endpoint event (hazard ratio [HR]0·65 [95% CI 0·49–0·88]; p=0·0047). Fluid retention and anaemia adverse events, which have been previously attributed to endothelin receptor antagonists, were more frequent in the atrasentan group than in the placebo group. Hospital admission for heart failure occurred in 47 (3·5%)of 1325 patients in the atrasentan group and 34 (2·6%)of 1323 patients in the placebo group (HR 1·33 [95% CI 0·85–2·07]; p=0·208). 58 (4·4%)patients in the atrasentan group and 52 (3·9%)in the placebo group died (HR 1·09 [95% CI 0·75–1·59]; p=0·65). Interpretation: Atrasentan reduced the risk of renal events in patients with diabetes and chronic kidney disease who were selected to optimise efficacy and safety. These data support a potential role for selective endothelin receptor antagonists in protecting renal function in patients with type 2 diabetes at high risk of developing end-stage kidney disease. Funding: AbbVie

Does Information Quality Matter?

acceptedVersio

Informality and Teamwork

This discussion paper considers examples of informal communication among multidisciplinary medical teams in the context of their weekly meeting. Informal exchanges are frequent, particularly at the beginnings and endings of meetings, are often private (1-2-1). This opportunity for synchronous face-to-face informal exchange is highly valued and reported to be a strong motivator for attendance at MDT meetings. The exchanges are both task and non-task related and tend to be conversational. We suggest that the informal communication we observe plays an important role in helping team cohesivenes

Does Information Quality Matter?

acceptedVersio

Exchange of information between hospital and home health care: A longitudinal perspective

In this paper we present a longitudinal perspective of exchange of information providers in hospital and home health care. More specifically we address how this practice has changed over the last six years. In three different studies we have investigated how the information exchange between hospital and home health care throughout a patient transition from admission to discharge has changed over the last six years. The information processes have gone from being mainly paper-based to being digitalized. However, there are still professional challenges to overcome which may contribute to improvements for patients in transition

Exchange of information between hospital and home health care: A longitudinal perspective

In this paper we present a longitudinal perspective of exchange of information providers in hospital and home health care. More specifically we address how this practice has changed over the last six years. In three different studies we have investigated how the information exchange between hospital and home health care throughout a patient transition from admission to discharge has changed over the last six years. The information processes have gone from being mainly paper-based to being digitalized. However, there are still professional challenges to overcome which may contribute to improvements for patients in transition

A notion of event quality for contextualized planning and decision support systems

This paper presents an approach for contextualizing an event-based decision support system for scheduling patient assessments in a hospital. To cope with unexpected delays, patient coordinators often pursue a worst case scenario when scheduling patient assessments, leading to an underutilization of human resources and equipment when the procedure went without complications. We present a context-based decision support system for patient planning that helps the patient coordinator with taking well-informed rescheduling decisions and anticipating changes in other patients' schedules. The system uses information and events produced by medical equipment. As these events can be non-deterministic, we demonstrate how our domain specific context model can be used to contextualize events to enhance their quality and ascertain their meaning.status: publishe

From low-level events to activities - a pattern-based approach

Process mining techniques analyze processes based on event data. A crucial assumption for process analysis is that events correspond to occurrences of meaningful activities. Often, low-level events recorded by information systems do not directly correspond to these. Abstraction methods, which provide a mapping from the recorded events to activities recognizable by process workers, are needed. Existing supervised abstraction methods require a full model of the entire process as input and cannot handle noise. This paper proposes a supervised abstraction method based on behavioral activity patterns that capture domain knowledge on the relation between activities and events. Through an alignment between the activity patterns and the low-level event logs an abstracted event log is obtained. Events in the abstracted event log correspond to instantiations of recognizable activities. The method is evaluated with domain experts of a Norwegian hospital using an event log from their digital whiteboard system. The evaluation shows that state-of-the art process mining methods provide valuable insights on the usage of the system when using the abstracted event log, but fail when using the original lower level event log