Over the past decade, clinical studies and clinical practice guidelines have suggested the use of higher small solute clearance targets for patients on peritoneal dialysis (PD). This study asks ...whether these recommendations have translated into changes in clinical prescription of PD.
Data were collected annually from 1996 to 1999 on all prevalent dialysis patients in 24 Canadian centers, accounting for approximately 40% of the Canadian chronic dialysis population. Approximately a third of these patients were on PD. Full details of each patient's prescription were recorded, with particular attention to dwell volumes and frequency of exchanges for continuous ambulatory PD (CAPD) and to total treatment volumes and day dwells for automated PD (APD). The most recent Kt/V and creatinine clearance values available were recorded for each patient and the overall results for each year were compared to present treatment recommendations.
24 university- and community-based hospitals.
From 1996 to 1999, the use of APD, relative to CAPD, grew from 14% to 28% of all PD patients. Among CAPD patients, the proportion using dwell volumes greater than 2 L rose from 14% to 32%, and the proportion doing more than 4 dwells per day rose from 16% to 28%. The mean daily volume of prescribed fluid for CAPD patients increased from 8.3 to 9.1 L. As a result, the proportion of patients achieving a weekly Kt/V above 2.0 rose from 54% to 72%, and those receiving a Kt/V less than 1.7 fell from 22% to 10%. For creatinine clearance, those exceeding 60 L per week rose from 63% to 73%. For APD, the mean treatment volume rose from 11.8 L in 1996 to plateau at about 13.4 L in 1998 and 1999. However, the proportion of patients receiving more than 1 day dwell grew from 31% in 1998 to 40% in 1999, and the proportion that were "day dry" fell from 25% to 17%. For APD, the proportion of patients with a Kt/V above 2.0 rose from 67% to 77%, and with a creatinine clearance above 60 L, from 62% to 70%. The proportion with no recent clearance value recorded fell during the course of the study, from 45% to 27%.
There was a marked change in PD prescription practices in Canada during the second half of the 1990s. This occurred in response to clinical studies and publication of guidelines. There is room for further improvement, especially with respect to the proportion of patients that did not have regular clearance measurements made.
Information on early, guideline discordant referrals in nephrology is limited. Our objective was to investigate trends in referral patterns to nephrology for patients with chronic kidney disease ...(CKD). Retrospective cohort study of adults with greater than or equal to1 visits to a nephrologist from primary care with greater than or equal to1 serum creatinine and/or urine protein measurement <180 days before index nephrology visit, from 2006 and 2019 in Alberta, Canada. Guideline discordant referrals were those that did not meet greater than or equal to1 of: Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m.sup.2, persistent albuminuria (ACR greater than or equal to 300 mg/g, PCR greater than or equal to 500 mg/g, or Udip greater than or equal to 2+), or progressive and persistent decline in eGFR until index nephrology visit (greater than or equal to 5 mL/min/1.73m.sup.2). Of 69,372 patients with CKD, 28,518 (41%) were referred in a guideline concordant manner. The overall rate of first outpatient visits to nephrology increased from 2006 to 2019, although guideline discordant referrals showed a greater increase (trend 21.9 per million population/year, 95% confidence interval 4.3, 39.4) versus guideline concordant referrals (trend 12.4 per million population/year, 95% confidence interval 5.7, 19.0). The guideline concordant cohort were more likely to be on renin-angiotensin system blockers or beta blockers (hazard ratio 1.14, 95% confidence interval 1.12, 1.16), and had a higher risk of CKD progression (hazard ratio 1.09, 95% confidence interval 1.06, 1.13), kidney failure (hazard ratio 7.65, 95% confidence interval 6.83, 8.56), cardiovascular event (hazard ratio 1.40, 95% confidence interval 1.35,1.45) and mortality (hazard ratio 1.58, 95% confidence interval 1.52, 1.63). A significant proportion nephrology referrals from primary care were not consistent with current guideline-recommended criteria for referral. Further work is needed to identify quality improvement initiatives aimed at enhancing referral patterns of patients with CKD.
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Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
IMPORTANCE: Kidney disease is a substantial worldwide clinical and public health problem, but information about available care is limited. OBJECTIVE: To collect information on the current state of ...readiness, capacity, and competence for the delivery of kidney care across countries and regions of the world. DESIGN, SETTING, AND PARTICIPANTS: Questionnaire survey administered from May to September 2016 by the International Society of Nephrology (ISN) to 130 ISN-affiliated countries with sampling of key stakeholders (national nephrology society leadership, policy makers, and patient organization representatives) identified by the country and regional nephrology leadership through the ISN. MAIN OUTCOMES AND MEASURES: Core areas of country capacity and response for kidney care. RESULTS: Responses were received from 125 of 130 countries (96%), including 289 of 337 individuals (85.8%, with a median of 2 respondents interquartile range, 1-3), representing an estimated 93% (6.8 billion) of the world’s population of 7.3 billion. There was wide variation in country readiness, capacity, and response in terms of service delivery, financing, workforce, information systems, and leadership and governance. Overall, 119 (95%), 95 (76%), and 94 (75%) countries had facilities for hemodialysis, peritoneal dialysis, and kidney transplantation, respectively. In contrast, 33 (94%), 16 (45%), and 12 (34%) countries in Africa had facilities for hemodialysis, peritoneal dialysis, and kidney transplantation, respectively. For chronic kidney disease (CKD) monitoring in primary care, serum creatinine with estimated glomerular filtration rate and proteinuria measurements were reported as always available in only 21 (18%) and 9 (8%) countries, respectively. Hemodialysis, peritoneal dialysis, and transplantation services were funded publicly and free at the point of care delivery in 50 (42%), 48 (51%), and 46 (49%) countries, respectively. The number of nephrologists was variable and was low (<10 per million population) in Africa, the Middle East, South Asia, and Oceania and South East Asia (OSEA) regions. Health information system (renal registry) availability was limited, particularly for acute kidney injury (8 countries 7%) and nondialysis CKD (9 countries 8%). International acute kidney injury and CKD guidelines were reportedly accessible in 52 (45%) and 62 (52%) countries, respectively. There was relatively low capacity for clinical studies in developing nations. CONCLUSIONS AND RELEVANCE: This survey demonstrated significant interregional and intraregional variability in the current capacity for kidney care across the world, including important gaps in services and workforce. Assuming the responses accurately reflect the status of kidney care in the respondent countries, the findings may be useful to inform efforts to improve the quality of kidney care worldwide.
Cancer has been an enormous pain point for patients and regulatory bodies across the globe. In Dec. 2023, the US FDA released guidance on benzene-grade carbomer formulations, which triggered ...pharmaceutical manufacturers to assess risk, test finished products, and reformulate drug products with benzene-grade carbomer. The immediate implementation of the stoppage of finished products with benzene-grade carbomers has threatened pharmaceutical excipients and finished product manufacturers. The gravity of this situation prompted the US Pharmacopeia to extend the deadline for discontinuation from August 1, 2025, to August 1, 2026, allowing manufacturers ample time for reformulation and regulatory compliance.
There is an immediate need to understand the guidance and to learn how manufacturers should do the risk assessment and approach reformulation. This review provides an in-depth analysis of the risk assessment and reformulation processes involved in various dosage forms utilizing benzene-grade carbomer, supported by specific case studies.
This review offers insights into navigating the USFDA guidelines to ensure formulation safety and compliance, thus enabling pharmaceutical practitioners to uphold the highest standards of patient care and tackle life cycle management challenges.
The decision of the USFDA to restrict the usage of high benzene content of carbomer in the formulation is a welcome move. This article has shown a way for researchers to see opportunities in the path and provide best-in-class medicines to patients with a better formulation safety profile.
Graphical Abstract
Kidney transplantation (KT) is the optimal treatment for kidney failure and is associated with better quality of life and survival relative to dialysis. However, knowledge of the current capacity of ...countries to deliver KT is limited. This study reports on findings from the 2018 International Society of Nephrology Global Kidney Health Atlas survey, specifically addressing the availability, accessibility, and quality of KT across countries and regions.
Data were collected from published online sources, and a survey was administered online to key stakeholders. All country-level data were analyzed by International Society of Nephrology region and World Bank income classification.
Data were collected via a survey in 182 countries, of which 155 answered questions pertaining to KT. Of these, 74% stated that KT was available, with a median incidence of 14 per million population (range: 0.04-70) and median prevalence of 255 per million population (range: 3-693). Accessibility of KT varied widely; even within high-income countries, it was disproportionately lower for ethnic minorities. Universal health coverage of all KT treatment costs was available in 31%, and 57% had a KT registry.
There are substantial variations in KT incidence, prevalence, availability, accessibility, and quality worldwide, with the lowest rates evident in low- and lower-middle income countries. Understanding these disparities will inform efforts to increase awareness and the adoption of practices that will ensure high-quality KT care is provided around the world.
Many patients with non-dialysis dependent chronic kidney disease (CKD) live far from the closest nephrologist; although reversible, this might constitute a barrier to optimal care. In order to ...evaluate outcomes, we selected 31,452 outpatients older than 18 years with an estimated glomerular filtration rate (eGFR) less than 45 ml/min per 1.73 m2 who had serum creatinine measured at least once during 2005 in Alberta, Canada. We then used logistic regression to examine the association between outcomes of 6545 patients who lived more than 50 km from the nearest nephrologist. Over a median follow-up of 27 months, 7684 participants died and 15,075 were hospitalized at least once. Compared with those living within 50 km, those further away were significantly less likely to visit a nephrologist or a multidisciplinary CKD clinic within 18 months of the index measurement of the eGFR. Similarly, remote dwellers with diabetes were significantly less likely to have hemoglobin A1c evaluated within 1 year of the index eGFR measurement, to have urinary albumin assessed biannually, or to receive an angiotensin converting enzyme inhibitor or receptor blocker in the setting of diabetes or proteinuria. Remote-dwelling participants were also significantly more likely to die or be hospitalized during follow-up than those living closer. Thus, among people with CKD, remote dwellers were less likely to receive specialist care, recommended laboratory testing, and appropriate medications, and were more likely to die or be hospitalized compared with those living closer to a nephrologist.
Background Observational studies indicate that routine measurements of access blood flow and use of Doppler ultrasound improve vascular access outcomes in hemodialysis patients, but randomized trials ...reached conflicting conclusions. Study Design Systematic review and meta-analysis. Setting & Population Adult hemodialysis patients with arteriovenous accesses. Selection Criteria for Studies: Randomized trials. Intervention Screening with access blood flow measurements or Doppler ultrasound. Outcomes Thrombosis, access loss, and resource use. Results Of 1,613 identified citations and abstracts, 69 full articles were retrieved, and 12 randomized controlled trials comparing access screening (using access blood flow– or ultrasound-based screening) with standard care in a total of 1,164 participants were included. In meta-regression, vascular access type was significantly associated with the relative risk of thrombosis associated with screening ( P < 0.01), supporting the need to stratify analyses on access type. In the 4 trials that studied arteriovenous fistulas, access blood flow– or ultrasound-based screening significantly decreased the risk of access thrombosis (relative risk RR, 0.47; 95% confidence interval CI, 0.28 to 0.77; 360 participants; I2 = 8%), but not the risk of fistula loss (RR, 0.65; 95% CI, 0.28 to 1.51, I2 = 0%) or resource use. Conversely, no decrease in risk of thrombosis (RR, 0.94; 95% CI, 0.77 to 1.16; 446 participants; I2 = 0%) or access loss (RR, 1.08; 95% CI, 0.83 to 1.40; I2 = 0%) was identified in trials studying grafts. Limitations Overall trial quality was moderate to poor, many trials did not report all clinically or economically relevant outcomes, and statistical power generally was low. Conclusions There was no evidence that screening with access blood flow measurements or Doppler ultrasound is of benefit to patients with grafts. Access blood flow screening may prevent access thrombosis in arteriovenous fistulas, but may not reduce the risk of access loss or extent of resource use. These findings have implications for clinical practice guidelines and for future research.
Hemodialysis (HD) is the most common form of kidney replacement therapy. This study aimed to examine the use, availability, accessibility, affordability, and quality of HD care worldwide.
A ...cross-sectional survey.
Stakeholders (clinicians, policy makers, and consumer representatives) in 182 countries were convened by the International Society of Nephrology from July to September 2018.
Use, availability, accessibility, affordability, and quality of HD care.
Descriptive statistics.
Overall, representatives from 160 (88%) countries participated. Median country-specific use of maintenance HD was 298.4 (IQR, 80.5-599.4) per million population (pmp). Global median HD use among incident patients with kidney failure was 98.0 (IQR, 81.5-140.8) pmp and median number of HD centers was 4.5 (IQR, 1.2–9.9) pmp. Adequate HD services (3-4 hours 3 times weekly) were generally available in 27% of low-income countries. Home HD was generally available in 36% of high-income countries. 32% of countries performed monitoring of patient-reported outcomes; 61%, monitoring of small-solute clearance; 60%, monitoring of bone mineral markers; 51%, monitoring of technique survival; and 60%, monitoring of patient survival. At initiation of maintenance dialysis, only 5% of countries used an arteriovenous access in almost all patients. Vascular access education was suboptimal, funding for vascular access procedures was not uniform, and copayments were greater in countries with lower levels of income. Patients in 23% of the low-income countries had to pay >75% of HD costs compared with patients in only 4% of high-income countries.
A cross-sectional survey with possibility of response bias, social desirability bias, and limited data collection preventing in-depth analysis.
In summary, findings reveal substantial variations in global HD use, availability, accessibility, quality, and affordability worldwide, with the lowest use evident in low- and lower-middle–income countries.
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The healthcare supply chain involves obtaining resources, managing supplies, and delivering goods and services to patients across multiple teams, stakeholders, and geographical boundaries. With such ...a complex structure, the healthcare supply chain is vulnerable to fraud, inaccurate data, and lack of transparency. These misdeeds cost businesses money and harm health. To address these issues, the health care supply chain needs an end-to-end decentralized track-and-trace system. Most centralized systems risk drug and data safety. This paper presents an Ethereum blockchain-based solution for a health care supply chain track-and-trace mechanism that uses smart contracts and data immutability. Hash functions store data in a public distributed ledger. This protects and discloses data. Smart contracts automate agreement execution so all parties know the outcome instantly, without an intermediary or time loss. It also outlined decentralized healthcare supply chain application architecture and algorithms. This paper proposes a system to address the lack of transparency and tracking in traditional supply chains. The blockchain-based method proposed in this paper runs on Solidity smart contracts. The system’s algorithms and methods are tested against a variety of inputs, and the results are presented as an average gas cost for specific functionality. The proposed system tracks goods’ histories (medicine). The average gas cost for all accounts is 18,027.2. Overall, log gas costs 48,118.6 to buy medicine, gas costs 229,607.5, and to log out 14,275.The results of the proposed system are compared to state-of-the-art methods. Thus, the presented work allows a seamless flow of medicines via blockchain and smart contracts without intermediaries. Finally, it addresses building a secure pharma supply chain application for blockchain 4.0.
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