Short- and long-term effects of a cardiac rehabilitation program in patients implanted with a left ventricular assist device

The efficacy of cardiac rehabilitation in heart-failure patients who received a left-ventricular assist device (LVAD) instead of heart transplantation (HTx) is still unclear. This study aims to evaluate whether cardiac rehabilitation is beneficial in LVAD as HTx patients in the short term and whether its effects in LVAD patients persist over time. Twenty-five LVAD patients were evaluated by functional and psychological tests at admission (T0) and discharge (T1) of a 4-week inpatient structured rehabilitation program, and follow-ups 3 (T2), 6 (T3), and 12 months (T4) after discharge. Twenty-five matched HTx patients were also studied from T0 to T1 to compare the improvements in the six-minute walk test (6MWT). The quality-of-life scores substantially improved in LVAD patients and the 6MWT showed the same functional recovery as in HTx patients from T0 to T1. After T1, numerous LVAD patients withdrew from the study. However, the 6MWT outcome increased further from T1 to T3, with a positive trend during the follow-ups. Hemoglobin and the ventilatory performance increased, and the psychological perception of heart-failure symptoms and pain further improved at T2. In conclusion, exercise-based rehabilitation programs provide similar beneficial effects in LVAD and HTx patients, without deterioration in LVAD patients up to 12 months after discharge

Citrate high volume on-line hemodiafiltration modulates serum Interleukin-6 and Klotho levels: the multicenter randomized controlled study \u201cHephaestus

Background: Studies addressing the anti-inflammatory properties of citrate dialysate enrolled patients in both hemodialysis (HD) and hemodiafiltration (HDF), the latter not adjusted for adequate convective exchange. This is a potential source of confounding in that HDF itself has anti-inflammatory effects regardless of the buffer, and optimal clinical outcomes are related to the amount of convection. Methods: To distinguish the merits of the buffer from those of convection, we performed a 6-month, prospective, randomized, crossover AB-BA study. Comparisons were made during the 3-month study period of on-line HDF with standard dialysate containing three mmol of acetic acid (OL-HDFst) and the 3-month of OL-HDF with dialysate containing one mmol of citric acid (OL-HDFcit). Primary outcome measure of the study was interleukin-6 (IL-6). Klotho, high sensitivity C-reactive protein (hsCRP), fetuin and routine biochemical parameters were also analyzed. Results: We analyzed 47 patients (mean age 64 years, range 27-84 years) enrolled in 10 participating Nephrology Units. Convective volumes were around 25 L/session with 90 percent of sessions > 20 L and f2-microglobulin reduction rate 76% in both HDFs. Baseline median IL-6 values in OL-HDFst were 5.6 pg/ml (25:75 interquartile range IQR 2.9:10.6) and in OL-HDFcit 6.6 pg/ml (IQR 3.4:11.4 pg/ml). The difference was not statistically significant (p 0.88). IL-6 values were lower during OL-HDFcit than during OL-HDFst, both when analyzed as the median difference of overall IL-6 values (p 0.02) and as the median of pairwise differences between the baseline and the 3-month time points (p 0.03). The overall hsCRP values too, were lower during OL-HDFcit than during OL-HDFst (p 0.01). Klotho levels showed a time effect (p 0.02) and the increase was significant only during OL-HDFcit (p 0.01). Conclusions: Citrate buffer modulated IL-6, hsCRP and Klotho levels during high volume OL-HDF. These results are not attributable to differences in the dialysis schedule and may suggest a potential anti-inflammatory and anti-senescent effect of citrate even in dialysis patients with low grade inflammatio

How can advance care planning support hope in patients with advanced cancer and their families: a qualitative study as part of the international ACTION trial

Objective Clinicians' fears of taking away patients' hope is one of the barriers to advance care planning (ACP). Research on how ACP supports hope is scarce. We have taken up the challenge to specify ways in which ACP conversations may potentially support hope. Methods In an international qualitative study, we explored ACP experiences of patients with advanced cancer and their personal representatives (PRs) within the cluster-randomised control ACTION trial. Using deductive analysis of data obtained in interviews following the ACP conversations, this substudy reports on a theme of hope. A latent thematic analysis was performed on segments of text relevant to answer the research question. Results Twenty patients with advanced cancer and 17 PRs from Italy, the Netherlands, Slovenia, and the United Kingdom were participating in post-ACP interviews. Three themes reflecting elements that provide grounds for hope were constructed. ACP potentially supports hope by being (I) a meaningful activity that embraces uncertainties and difficulties; (II) an action towards an aware and empowered position; (III) an act of mutual care anchored in commitments. Conclusion Our findings on various potentially hope supporting elements of ACP conversations provide a constructive way of thinking about hope in relation to ACP that could inform practice

Missing not at random in end of life care studies: multiple imputation and sensitivity analysis on data from the ACTION study

Background: Missing data are common in end-of-life care studies, but there is still relatively little exploration of which is the best method to deal with them, and, in particular, if the missing at random (MAR) assumption is valid or missing not at random (MNAR) mechanisms should be assumed. In this paper we investigated this issue through a sensitivity analysis within the ACTION study, a multicenter cluster randomized controlled trial testing advance care planning in patients with advanced lung or colorectal cancer. Methods: Multiple imputation procedures under MAR and MNAR assumptions were implemented. Possible violation of the MAR assumption was addressed with reference to variables measuring quality of life and symptoms. The MNAR model assumed that patients with worse health were more likely to have missing questionnaires, making a distinction between single missing items, which were assumed to satisfy the MAR assumption, and missing values due to completely missing questionnaire for which a MNAR mechanism was hypothesized. We explored the sensitivity to possible departures from MAR on gender differences between

The impact of ACP on patient's relationships

Background: In the period 2013-2018 an important European study (ACTION) involving six countries, financed according to the 7\ub0 European framework, has been performed. The ACTION study dealt with the issue of advance care planning (ACP) in oncology and searched for evidence of its impact on patient and family

Target measurements influence on level crossing detection system safety determination

The design of critical safety systems is usually approached through the investigation about the applicability of specific standards that can be applied in that specific field of interest. Even if very often this design strategy can be satisfactory to address the most part of common problems, sometimes a generalized approach may lead to tricky situations where some crucial aspects can be neglected. This risk is high when new technologies or advanced measurement systems are designed. The main reasons may lay in some hidden hazards related to the sensor physics or to the specific context. In this paper the authors discuss how the implementation of a peculiar system for level crossing monitoring (LC) based on a specific radar technology can be jeopardized if a limiting standard approach is followed. Moreover, a sharp analysis of the target to be detected is performed. Safety systems based on single or multi sensor architectures are analyzed discussing the advantages and pitfalls of the different designs in terms of system RAMS parameters. Considerations about measurement uncertainties due to the type and orientation of the specific item to be detected are presented on an empirical basis as well