Automated Peritoneal Dialysis With Remote Patient Monitoring: Clinical Effects and Economic Consequences for Poland.

OBJECTIVES: Remote patient monitoring (RPM) of patients treated with automated peritoneal dialysis (APD) at home allows clinicians to supervise and adjust the dialysis process remotely. This study aimed to review recent scientific studies on the use of RPM in patients treated with APD and based on extracted relevant data assess possible clinical implications and potential economic value of introducing such a system into practice in Poland. METHODS: A systematic literature review was performed in the MEDLINE, EMBASE, and Cochrane databases. The model of clinical effects and costs associated with APD was built as a cost-effectiveness analysis with a 10-year time horizon from the Polish National Health Fund perspective. Cost-effectiveness analysis compared 2 strategies: APD with RPM versus APD without RPM. RESULTS: Thirteen publications assessing the clinical value of RPM among patients with APD were found. The statistical significance of APD with RPM compared with APD without RPM was identified for the main clinical outcomes: frequency and length of hospitalizations, APD technique failure, and death. An incremental cost-effectiveness ratio was equal to €27 387 per quality-adjusted life-year. The obtained incremental cost-effectiveness ratio is below the willingness-to-pay threshold for the use of medical technologies in Poland (€36 510 per quality-adjusted life-year), which means that APD with RPM was a cost-effective technology. CONCLUSIONS: RPM in patients starting APD is a clinical option that is worth considering in Polish practice because it has the potential to decrease the frequency of APD technique failure and shorten the length of hospitalization.

Full-field in vivo experimental study of the strains of a breathing human abdominal wall with intra-abdominal pressure variation.

The presented study aims to assess the mechanical behaviour of the anterior abdominal wall based on an in vivo experiment on humans. Full-field measurement of abdominal wall displacement during changes of intra-abdominal pressure is performed using a digital image correlation (DIC) system. Continuous measurement in time enables the observation of changes in the strain field during breathing. The understanding of the mechanical behaviour of a living human abdominal wall is important for the proper design of surgical meshes used for ventral hernia repair, which was also a motivation for the research presented below. The research refers to the strain field of a loaded abdominal wall and presents the evolution of principal strains and their directions in the case of 12 subjects, 8 male and 4 female. Peritoneal dialysis procedure allows for the measurement of intra-abdominal pressure after fluid introduction. High variability among patients is observed, also in terms of principal strain direction. Subjects exhibit intra-abdominal pressure of values from 11 to 21 cmH2O. However, the strain values are not strongly correlated with the pressure value, indicating variability of material properties.

Local and Systemic Immunity Are Impaired in End-Stage-Renal-Disease Patients Treated With Hemodialysis, Peritoneal Dialysis and Kidney Transplant Recipients Immunized With BNT162b2 Pfizer-BioNTech SARS-CoV-2 Vaccine.

Vaccination against COVID-19 in patients with end-stage renal disease (ESRD) on replacement therapy and kidney transplant recipients (KTRs) is particularly important due to the high mortality rate. Here, we tested the local and systemic immunity to the novel Pfizer BioNTech (BNT162b2) messenger RNA (mRNA) in ESRD, KTR patients, and healthy individuals (150 subjects). The ESRD group was divided into: hemodialysis (HD) and peritoneal dialysis (PD). We investigated the local and systemic immunity based on anti-N (nucleoprotein) and anti-S (spike1/2) Immunoglobulin A (IgA) and Immunoglobulin G (IgG) antibodies, respectively. Additionally, we performed an Interferon gamma (IFN-γ) release test Interferon-gamma release assay (IGRA) to monitor the cellular component of vaccine response. The control group had the highest level of anti-S IgG antibodies (153/2,080 binding antibody units (BAU)/ml) among all analyzed patients after the 1st and 2nd dose, respectively. The HD group (48/926 BAU/ml) had a diminished antibody level compared to PD (93/1,607 BAU/ml). Moreover, the seroconversion rate after the 1st dose was lower in HD than PD (56% vs. 86%). KTRs had extremely low seroconversion (33%). IgA-mediated immunity was the most effective in the control group, while other patients had diminished IgA production. We observed a lower percentage of vaccine responders based on the IFN-γ level in all research participants (100% vs. 85% in control, 100% vs. 80% in PD, 97% vs. 64% in HD). 63% of seropositive KTRs had a positive IGRA, while 28% of seronegative patients produced IFN-γ. Collectively, PD patients had the strongest response among ESRD patients. Two doses of the Pfizer vaccine are ineffective, especially in HD and KTRs. A closer investigation of ESRD and KTRs is required to set the COVID-19 vaccine clinical guidance. Clinical Trial Registration Number: www.ClinicalTrials.gov, identifier: NCT04 905 862.

Inhaled opioids for cancer pain relief: A narrative review.

ABSTRACT: Despite the many new possibilities, cancer pain treatment is not always effective and often poses a challenge for practitioners. At the end-of-life care, both oral and subcutaneous drug delivery very often are not attainable. The increasing number of patients in terminal stage of chronic diseases forced us to look for the alternative ways of administration of pain treatment. In this context, the potentially rapid onset of action and ease of use make aerosolized drug delivery an attractive option in palliative care settings. The objective of this review was to identify literature on pain relief with inhaled opioids. The evidence suggests that nebulized opioids might be effective in the treatment of pain in various aetiologies; however, randomized controlled studies on nebulization therapy for cancer pain are lacking.

Waning Humoral Response after COVID-19 mRNA Vaccination in Maintenance Dialysis Patients and Recovery after a Complementary Third Dose.

The aim of this study was to analyze the waning of anti-spike (S) antibodies after mRNA vaccination against COVID-19 in maintenance dialysis patients, and to assess the safety and effectiveness of the complementary third dose. This was a prospective, longitudinal study in which we analyzed the kinetics of antibodies up to six months after a two-dose vaccination (first protocol) in infection-naïve dialysis patients (IN-Ds), previously infected dialysis patients (PI-Ds) and subjects without chronic kidney disease (the controls), as well as their humoral response to the third dose of the same mRNA vaccine (second protocol). The respective reduction in antibody titer after 3 and 6 months by 82.9% and 93.03% in IN-Ds (n = 109), 73.4% and 93.36% in PI-Ds (n = 32) and 75.5% and 88.8% in the controls (n = 20) was demonstrated. Consequently, a protective antibody titer above 141 BAU/mL was found in only 47.7% and 23.8% of IN-Ds after 3 and 6 months, respectively. After the third vaccine dose, a significant increase in antibody titer was observed in all groups, with increases by a factor of ×51.6 in IN-Ds, ×30.1 in the controls and ×8.4 in PI-Ds. The median antibody titer after the third dose differed significantly between groups, and was the highest in PI-Ds: PI-Ds, 9090 (3300−15,000) BAU/mL; the controls, 6945 (2130−11,800); IN-Ds, 3715 (1470−7325) (p < 0.001). In conclusion, we observed similar degrees of antibody waning in all patients. After 3 months, over half of the infection-naïve dialysis patients had a very low antibody titer, and almost twenty percent of them had no antibodies at all. The humoral response to the third dose was very good, raising their titer of antibodies to a higher level than those in the general population who have received the primary two-dose scheme. The results support the administration of a complementary third dose of the mRNA vaccine for dialysis patients as soon as possible.

A novel in vivo approach to assess strains of the human abdominal wall under known intraabdominal pressure.

The study concerns mechanical behaviour of a living human abdominal wall. A better mechanical understanding of a human abdominal wall and recognition of its material properties is required to find mechanically compatible surgical meshes to significantly improve the treatment of ventral hernias. A non-invasive methodology, based on in vivo optical measurements is proposed to determine strains of abdominal wall corresponding to a known intraabdominal pressure. The measurement is performed in the course of a standard procedure of peritoneal dialysis. A dedicated experimental stand is designed for the experiment. The photogrammetric technique is employed to recover the three-dimensional surface geometry of the anterior abdominal wall at the initial and terminal instants of the dialysis. This corresponds to two deformation states, before and after filling the abdominal cavity with dialysis fluid. The study provides information on strain fields of living human abdominal wall. The inquiry is aimed at principal strains and their directions, observed at the level from -10% to 17%. The intraabdominal pressure related to the amount of introduced dialysis fluid measured within the medical procedure covers the range 11-18.5 cmH2O. The methodology leads to the deformation state of the abdominal wall according to the corresponding loading conditions. Therefore, the study is a step towards an identification of mechanical properties of living human abdominal wall.

Pregnancy After Kidney Transplantation With Maternal and Pediatric Outcomes: A Single-Center Experience.

Outcomes of pregnancies after kidney transplantation were evaluated. Thirty-one pregnancies in 26 women were noted. The mean maternal age at pregnancy was 31 ± 5 years (range, 23-44 years). The interval between transplantation and conception was 54 ± 51 months (range, 7-213 months). The mean serum creatinine concentration before conception was 1.28 ± 0.4 mg/dL (range, 0.8-2.45 mg/dL), and mean estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration) was 62 ± 18 mL/min/1.73 m2 (range, 27-106 mL/min/1.73 m2). There were no maternal deaths. There was 1 case of suspected acute rejection after delivery. There was 1 case of graft loss during pregnancy. Maternal complications included edema (6/26), hypertension (7/26), increase of (2/26) or appearance of proteinuria (5/26), and preeclampsia (4/26). Mean creatinine increase during pregnancy was 0.02 mg/dL. Mean creatinine 1 year after pregnancy was 1.54 mg/dL (±0.8 mg/dL). There were 19 cesarean sections. Fetal outcomes included 25 live births, 4 abortions, and 2 stillbirths. Out of 25 live births, 22 children were considered healthy, 2 children had congenital defects, and there were 2 deaths at neonatal age. Mean pregnancy age was 35 ± 4 weeks (range, 24-40 weeks). The rate of premature deliveries was 15 of 25. Mean neonate birth weight was 2363 ± 1029 grams (range, 490-4100 grams). The rate of babies small for gestational age was 19%. During follow-up (range, 0.5-30 years) 5 of 26 patients lost grafts (between 3 and 15 years after pregnancy); most (20) of the children previously considered healthy had good long-term development. Our results confirm that risk of pregnancy in kidney transplant recipients can be accepted, and children considered healthy at delivery develop well.

Prognostic Value of Patient Knowledge of Cancer on Quality of Life in Advanced Lung Cancer During Chemotherapy.

The purpose of the study was to assess the impact of cancer knowledge and patient's lifestyle on QOL and the relationship between QOL and various environmental factors in patients with non-small-cell lung cancer treated with chemotherapy. The study group consisted of 129 patients with metastatic lung cancer patients treated between May 2010 and December 2015 in two centres. The knowledge of cancer and their lifestyle was rated by method of diagnostic survey, using the Behavioral Health Inventory IZZ by Prof. Juczynski. We sought factors affecting to response to treatment, overall survival and quality of life. The general level of knowledge of cancer and the level of health behaviours was low. Ninety percent of lung cancer patients were smokers. The average age of the study group was 64 years. Eighty-nine patients received chemotherapy with cisplatin, 28 schemes containing carboplatin, 6 inhibitors of EGFR tyrosine kinase, and 6 vinorelbine or gemcitabine monotherapy. Complete regression was observed in 2 patients, partial response in 33 patients (26%), stable disease in 51 (40%) and 54 (42%) patients had progression. In multivariate analysis, significant effects on survival were performance status, schemes of treatment and response to treatment. Quality of life before and after treatment did not differ from each other. We found impact on quality of life: performance status, response to treatment and knowledge of cancer and lifestyle. The level of knowledge of oncological patients and their lifestyle observed in clinical practice are associated with QOL.

Current epidemiology and practice patterns in prevention and treatment of PD-related infections in Poland.

BACKGROUND: Peritoneal dialysis (PD) related infections are associated with technique failure and mortality. The aim of this multicentre study was to examine epidemiology, treatment and outcomes of PD-related infections in Poland as well as practice patterns for prevention of these complications in the context of current ISPD recommendations. METHODS: A survey on PD practices in relation to infectious complications was conducted in 11 large Polish PD centres. Epidemiology of peritonitis and exit-site infections (ESI) was examined in all patients treated in these units over a 2 year period. RESULTS: The study included data on 559 PD patients with 62.4% on CAPD. Practice patterns for prevention of infectious complications are presented. The rate of peritonitis was 0.29 episodes per year at risk, with Gram positive microorganisms responsible for more than 50% of infections and 85.8% effectively treated. Diagnosis and treatment followed ISPD guidelines however most units did not provide an anti-fungal prophylaxis. Although neither of the centres reported routine topical mupirocin on catheter exit-site, the rate of ESI was low (0.1 episodes per year at risk), with Staphylococcus aureus as most common pathogen and full recovery in 78.3% of cases. CONCLUSION: The study shows rewarding outcomes in prevention and treatment of PD-associated infections, mainly due to a thorough compliance with the current ISPD guidelines, although some deviations from the recommendations in terms of practice patterns have been observed. More studies are needed in large numbers of patients to differentiate the importance of specific recommendations and further support the guidelines.

Nationwide survey on volunteers' training in hospice and palliative care in Poland.

BACKGROUND: Volunteers working in hospice and palliative care facilities in Poland undertake various activities which are performed in accordance with legal regulations and the individual policies of each hospice. The aim of this study was to explore the roles and training of volunteers working in hospice and palliative care settings. METHODS: A cross-sectional survey was carried out that investigated the services performed by volunteers and their preparation for work within residential hospices. Questionnaires were distributed to volunteers and hospice representatives, and the responses obtained underwent statistical analysis. PARTICIPANTS: A total of 180 volunteers and 28 hospice representatives from 29 residential hospices participated in this survey. RESULTS: All hospices surveyed were supported by volunteers. 79% of volunteers worked alongside patients and performed the following services: accompanying patients (76%), feeding patients (61%), cleaning rooms (48%), dressing and bathing (42%) and organising leisure time (40%). Fewer volunteers were involved in activities outside of patient support-for example, charity work and fundraising (34%), cleaning hospice buildings (23%) as well as providing information and education (22%). According to volunteers, prior to undertaking their duties, 64% participated in theoretical training and 37% took part in a practical course. The majority attended courses relating to general knowledge of hospice and palliative care (64%) and volunteer rights and duties (55%). CONCLUSIONS: Overall, proper training was an essential requirement needed to be fulfilled by volunteers, particularly when involved in direct patient support. Most volunteers were simultaneously involved in various areas of service; therefore, their training should be comprehensive.

Protein-energy wasting and asymmetric dimethylarginine in peritoneal dialysis patients.

Cardiovascular (CVS) morbidity and mortality in the peritoneal dialysis patients (PD) is 10-30-fold higher than in the general population. A relatively low level of adiponectin and a higher level of leptin are important predictors of vascular complications as well as CVS events in PD patients. The asymmetric dimethylarginine (ADMA), an endogenous inhibitor of nitric oxide synthase, is an important risk factor of CVS morbidity and mortality. It is very important to establish all CVS risk factors in the PD patients to prevent CVS morbidity and mortality in this population. The aim of the study was to determine the plasma concentration of ADMA and adipokines in relation to the protein-energy wasting (PEW) in PD patients. The study was performed in 30 PD patients and in the control group which consisted of 23 healthy volunteers. Plasma levels of hsC-reactive protein, TNF, IL-6, leptin, adiponectin, oxyLDL and ADMA were measured by ELISA method in both groups. The nutritional status was determined by measuring the albumin, body mass index (BMI), the percentage of body fat (%F), lean body mass (LBM) and Subjective Global Assessment Score (SGA). The adequacy of dialysis was estimated by weekly Kt/V. In all PD patients, significantly higher levels of ADMA, leptin, oxyLDL, hsCRP and TNF in comparison to controls were observed. In contrast to well-nourished subjects, patients with PEW, in addition to increased hsCRP, showed significantly higher ADMA. PEW was associated with high levels of ADMA and hsCRP and this could probably be responsible for increased CVS risk in PD patients.

Water soluble vitamins and peritoneal dialysis - State of the art.

This review presents the results of a systematic literature search concerning water soluble vitamins and peritoneal dialysis modality. We provide an overview of the data available on vitamin requirements, dietary intake, dialysis related losses, metabolism and the benefits of supplementation. We also summarise the current recommendations concerning the supplementation of vitamins in peritoneal dialysis and discuss the safety of an administration of vitamins in pharmacological doses.

Impact of gender and dialysis adequacy on anaemia in peritoneal dialysis.

PURPOSE: In the general population, haemoglobin (Hb) concentration is higher in men than in women. However, target Hb levels in dialysis patients are set constant regardless of the patient's sex. The aim of this study was to evaluate Hb concentration and the use of erythropoiesis-stimulating agents (ESA) in peritoneal dialysis (PD) patients taking gender and dialysis adequacy into account. METHODS: The study comprised two parts. The first was a cross-sectional analysis of Hb and ESA in 2180 prevalent PD patients. The second included 88 incident PD patients, followed for 36 months. During this time, the major parameters recorded at 12-month intervals included: Hb concentration, weekly ESA, total, renal, and peritoneal Kt/V. Erythropoietin resistance index (ERI) was calculated as the ratio between ESA dose and achieved Hb. RESULTS: In prevalent PD patients, Hb concentration was significantly lower in women, (11.2 ± 1.4 vs. 11.5 ± 1.6 g/dl; p < 0.001), despite higher doses of ESA (2691 ± 1821 vs. 2344 ± 1422; p = 0.001). Hb concentrations were related to dialysis adequacy in both cohorts. However, despite significantly higher Kt/V, women were characterized by a lower Hb level. In incident patients, this association was present throughout the observation period, while the ESA dose in women was significantly higher at every time point. In multiple regression analysis, gender was an independent determinant of ERI (b = 0.34; p < 0.05). CONCLUSIONS: Despite higher dialysis adequacy, Hb concentration in women treated with PD is significantly lower, and the ability to correct it impaired, as compared to men.

Biologically active form of vitamin B1 in human peritoneal effluent.

BACKGROUND: Supplementation with vitamin B1 protects the peritoneal membrane from inflammatory and oxidative insults and preserves residual kidney function in rat models of peritoneal dialysis (PD). It is assumed that an active form of vitamin B1, thiamin diphosphate (ThDP), is responsible for this protective effect. However, it has never been shown whether ThDP, a compound known not to cross cellular membranes, is actually detectable in human peritoneal effluent. OBJECTIVES: This study was designed to investigate the concentration, appearance rate, and daily loss of ThDP in the peritoneal effluent of patients treated with PD. MATERIAL AND METHODS: We performed 24-hour effluent collection as well as the peritoneal equilibration test (PET) and analyzed the relation between the transport characteristics of the peritoneal membrane and appearance rate of ThDP in a cohort of 26 PD patients. RESULTS: ThDP was detectable in peritoneal effluent in humans. ThDP appearance rate was independent of the transport characteristic of peritoneal membrane, and was not associated with peritoneal transport of other small solutes. CONCLUSIONS: We conclude that ThDP can be found in detectable concentrations in the peritoneal effluent in humans and is transported through the peritoneal membrane in a pattern independent of other small solutes. Our finding opens novel opportunities in further research on the protection of peritoneal membrane in humans.

Effect of balance Solution on the Peritoneal Membrane in Automated Peritoneal Dialysis.

Interference of conventional peritoneal dialysis fluids (cPDFs) with peritoneal membrane cell functions may be attributed to the dialysis fluid's low pH, high glucose concentration, and/or the presence of glucose degradation products (GDPs), the last of which leads to higher levels of advanced glycation end-products (AGEs). It has been suggested that the peritoneal membrane might be better preserved by using biocompatible solutions, including cancer antigetn 125 (CA125). This prospective, open-label, multicentre, randomized, controlled, cross-over phase IV study compared the in vivo biocompatibility of a neutral-pH, low-GDP peritoneal dialysis (PD) solution (balance) with a cPDF in automated PD (APD) patients. Our study revealed a significantly increased appearance rate and concentration of CA125 in the peritoneal effluent of APD patients treated with the neutral-pH, low-GDP solution balance versus a conventional PD solution.

Nutritional predictors of mortality in prevalent peritoneal dialysis patients.

Malnutrition remains one of the major predictors of mortality in peritoneal dialysis (PD) patients. The aim of the study was to evaluate the nutritional status of prevalent PD patients, and to determine the best predictors of outcome among anthropometric and laboratory indices of nutrition. The study included 106 prevalent PD patients from a single university-based unit. Anthropometric assessment at baseline included: body mass, body mass index (BMI), skinfold thickness, lean body mass (LBM), content of body fat (%F), mid-arm muscle circumference (MAMC). Laboratory analysis comprised of albumin and total cholesterol. Additionally, each patient underwent a subjective global assessment (SGA). The patients were followed for 36 months. Survival analyses were made with the Kaplan-Meier survival curve and the Cox proportional hazard model. Following SGA, malnutrition was diagnosed in 30 (28%) patients. Importantly, eight of the malnourished patients (27%) were nevertheless overweight or obese. Body weight and BMI showed complete lack of association with the outcome. In Kaplan-Meier analysis low: LBM, MAMC, albumin and cholesterol were significantly related to mortality. Cox analysis revealed that, following adjustment, LBM below median was independently associated with poor outcome (hazard ratio [HR] 3.15, 95% confidence interval [CI] 1.17-8.49, p=0.02). Moreover, the lowest quartile of total cholesterol showed independent association with mortality (HR 8.68, CI 2.14-35.21, p<0.01). Malnutrition is prevalent in patients undergoing PD, and overweight/obesity does not preclude its appearance. The most valuable nutritional indices in predicting outcome in this cohort were LBM and total cholesterol concentration.

The role of a pharmacist in a hospice: a nationwide survey among hospice directors, pharmacists and physicians.

BACKGROUND: Palliative care requires the collaborative efforts of an interdisciplinary team, and as such a range of health professionals should be involved in supporting patients with life-threatening diseases. As a part of this therapeutic network, pharmacists at residential hospices should be thoroughly involved in care, cooperate with other medical staff and perform pharmaceutical services in order to deliver safe and efficient pharmacotherapy. AIM: To provide an overview of the current state of pharmacy practice at Polish residential hospices. METHODS: A cross-sectional study was applied and three types of anonymous questionnaires were developed to collect data. Hospice directors, pharmacists and physicians from all residential hospices in Poland were invited to participate. RESULTS: 19 (61%) hospices collaborate with at least one pharmacist, who performs pharmaceutical services on the premises. 12 (75%) pharmacists provide advice concerning medicines and 11 (69%) are involved in various roles related to procurement, dispensing and storage of drugs, as well as creating procedures for these activities. Despite pharmacists' great level of involvement in drug policy, most of them are not members of the therapeutic team and they do not participate in ward rounds. Furthermore, the provision of clinical pharmaceutical services forms a minority of Polish hospital pharmacy practice. CONCLUSIONS: Although the role of a hospice-based pharmacist is focused on the provision of drugs, it should become more clinical, that is, more patient oriented. The data obtained should be used as a source of information for implementing potential changes to palliative care pharmacy.

Pharmacoeconomic considerations regarding hospice and palliative care according to pharmacists and hospice managers.

This study focused on pharmacoeconomic issues affecting pharmacists in residential hospices in Poland. We conducted a questionnaire survey among hospice pharmacists and their managers. The results revealed that the amount of money received from the National Health Fund is insufficient for drug purchasing and therefore hospices often raise additional funds from external sources. Because of the limited financing, pharmacists and hospice directors undertake various activities to reduce costs. Generic drug reimbursement, pharmacoeconomic analysis and participating in tenders to purchase drugs are the most common measures undertaken to decrease expenditure.