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Background: The leaders of health care organizations are grappling with rising expenses and surging demands for health services. In response, they are increasingly embracing artificial intelligence (AI) technologies to improve patient care delivery, alleviate operational burdens, and efficiently improve health care safety and quality., Objective: In this paper, we map the current literature and synthesize insights on the role of leadership in driving AI transformation within health care organizations., Methods: We conducted a comprehensive search across several databases, including MEDLINE (via Ovid), PsycINFO (via Ovid), CINAHL (via EBSCO), Business Source Premier (via EBSCO), and Canadian Business & Current Affairs (via ProQuest), spanning articles published from 2015 to June 2023 discussing AI transformation within the health care sector. Specifically, we focused on empirical studies with a particular emphasis on leadership. We used an inductive, thematic analysis approach to qualitatively map the evidence. The findings were reported in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews) guidelines., Results: A comprehensive review of 2813 unique abstracts led to the retrieval of 97 full-text articles, with 22 included for detailed assessment. Our literature mapping reveals that successful AI integration within healthcare organizations requires leadership engagement across technological, strategic, operational, and organizational domains. Leaders must demonstrate a blend of technical expertise, adaptive strategies, and strong interpersonal skills to navigate the dynamic healthcare landscape shaped by complex regulatory, technological, and organizational factors., Conclusions: In conclusion, leading AI transformation in healthcare requires a multidimensional approach, with leadership across technological, strategic, operational, and organizational domains. Organizations should implement a comprehensive leadership development strategy, including targeted training and cross-functional collaboration, to equip leaders with the skills needed for AI integration. Additionally, when upskilling or recruiting AI talent, priority should be given to individuals with a strong mix of technical expertise, adaptive capacity, and interpersonal acumen, enabling them to navigate the unique complexities of the healthcare environment., (©Abi Sriharan, Nigar Sekercioglu, Cheryl Mitchell, Senthujan Senkaiahliyan, Attila Hertelendy, Tracy Porter, Jane Banaszak-Holl. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 14.08.2024.)

Purpose: Frailty is common in older patients with chronic kidney disease (CKD) and has been considered an independent risk factor for adverse clinical outcomes in this population. CKD-associated mineral and bone metabolism (CKD-MBD) increases energy expenditure and causes malnutrition and inflammation leading to frailty. We investigated whether CKD-MBD markers and energy metabolism are associated with frailty in patients with advanced CKD on conservative management., Methods: In this cross-sectional study, we investigated factors associated with frailty in a sample of 75 patients ≥ 65 years, with stage 4 or 5 CKD. Collected data included age, sex, body mass index, physical activity status, educational level, Charlson Comorbidity Index, and laboratory markers. Frailty was evaluated according to Fried's classification., Results: Frailty was observed in 51.3% and pre-frailty in 47.3%. The frail population was significantly older, with a high proportion of females, more inactive, had lower educational levels, spent a long time sitting throughout the day, and had higher phosphate and fibroblast growth factor 21 (FGF-21). In the multivariate logistic analysis age (odds ratio 1.13, p = 0.026) and phosphate (odds ratio 3.38, p = 0.021) remained independently associated with frailty., Conclusion: Serum phosphate seems to be a toxin associated with the frailty phenotype in older patients with CKD. Whether strategies to decrease serum phosphate would reduce the risk of frailty in this population deserves further evaluation., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

Globally, healthcare systems are contending with a pronounced health human resource crisis marked by elevated rates of burnout, heightened job transitions, and an escalating demand for the limited supply of the existing health workforce. This crisis detrimentally affects the quality of patient care, contributing to long wait times, decreased patient satisfaction, and a heightened frequency of patient safety incidents and medical errors. In response to the heightened demand, healthcare organizations are proactively exploring solutions to retain their workforce. With women comprising over 70% of health human resources, this study seeks to gain insight into the unique experiences of women health professionals on the frontlines of healthcare and develop a conceptual framework aimed at facilitating organizations in effectively supporting the retention and advancement of women in healthcare frontline roles. We used grounded theory in this qualitative study. From January 2023 to May 2023, we conducted individual semi-structured interviews with 27 frontline HCWs working in Canada and representing diverse backgrounds. The data underwent thematic analysis, which involved identifying and comprehending recurring patterns across the information to elucidate emerging themes. Our analysis found that organizational, professional, and personal factors shape women's intentions to leave the frontline workforce. Reevaluating organizational strategies related to workforce, fostering a positive work culture, and building the capacity of management to create supportive work environment can collectively transform the work environment. By creating conditions that enable women to perform effectively and find satisfaction in their professional roles, organizations can enhance their ability to retain valuable talent., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Sriharan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Healthcare administrators steer their organizations' strategic direction with an emphasis on quality, value and efficiency, aiming to improve patient outcomes and ensure operational sustainability. Artificial intelligence (AI) has become a transformative force in healthcare in the past decade, with Canadian health systems and research institutions investing in AI solutions to address critical healthcare challenges. This primer delivers a fundamental guide to essential AI concepts in healthcare and provides practical guidance to prepare organizations for AI readiness., (Copyright © 2024 Longwoods Publishing.)

The COVID-19 pandemic has exacerbated health and social inequities among migrant groups more than others. Higher rates of poverty, unemployment, living in crowded households, and language barriers have placed resettled refugees at a higher risk of facing disparities during the COVID-19 pandemic. To understand how this most vulnerable population has been impacted by the ongoing pandemic, this study reports on the responses of 128 Iraqi refugees in the city of London, Ontario, to a survey on the economic, social, and health-related impacts that they have faced for almost two years since the beginning the pandemic. The analysis of the survey indicated that 90.4% of the study population reported having health concerns during the pandemic while 80.3% expressed facing financial distress. The results also show that 58.4% of respondents experienced some form of social isolation. These all suggest that refugees are faced with several barriers which can have a compounding effect on their resettlement experience. These findings provide resettlement and healthcare providers with some information that may assist in reducing the impact of COVID-19 and other possible health security emergencies on resettled refugees and their communities.

Background: Operations research techniques enable health care administrators to optimize resource allocation and to find solutions to staff and patient scheduling problems. We aimed to conduct the first systematic review of the international literature on the use of operations research for allocating deceased-donor kidneys., Methods: We searched the MEDLINE, EMBASE, and PubMed databases from inception to February 2023. Two reviewers independently screened the title/abstract and subsequently the full text of potentially eligible articles and abstracted the data. Quality assessment of the final set of studies was conducted using Subben's checklist., Results: Of the 302 citations identified, 5 studies were included. These studies covered three themes, including (1) provider-facing decision aids to determine the timing of transplant for single or multiple patients; (2) system-level planning on kidney allocation based on blood type matching rules; and (3) patient-facilitated wait times estimation using incomplete information. Markov models, sequential stochastic assignment models, and queuing models were amongst the most used techniques. Although we found all included studies to meet Subben's criteria, we believe the checklist in its current form lacks items to assess the validity of model inferences. As such, we ended this review with a set of practical recommendations., Conclusions: Our review demonstrated the utility of operations research techniques in assisting the system, healthcare providers, and patients in the transplantation process. More research is needed to reach a consensus on a model that can be used to support the decision-making of different stakeholders for efficient kidney allocation, with the ultimate goal of reducing the gap between kidney supply and demand and enhancing the population's well-being.

Introduction: The production of clinical practice guidelines (CPGs) has grown in the past years. Notwithstanding, the quality of these documents and their recommendations for the treatment of schizophrenia in children and adolescents is still unknown., Objective: To assess the quality of the guidelines and recommendations for the treatment of schizophrenia in this population., Methods: CPGs from 2004 to December 2020 were identified through a systematic search on EMBASE, MEDLINE, PsycINFO, PubMed, Epistemonikos, VHL, Global Index Medicus and specific CPG databases. The CPGs' quality was independently assessed by three reviewers using AGREE II and they were considered of high quality if they scored ≥60% in domains 3 and 6. The evidence classification systems were described, the quality of recommendations was assessed in pairs using AGREE-REX and the recommendations were compared., Results: The database search retrieved 3182 results; 2030 were screened and 29 were selected for full-text reading. Four guidelines were selected for extraction. Two CPGs were considered of high quality in the AGREE II assessment. We described the commonly agreed recommendations for each treatment phase. The pharmacological recommendations were described in all treatment phases. Scores of AGREE-REX were lower for psychosocial recommendations., Conclusion: There are still few clinical studies and CPGs regarding schizophrenia in children and adolescents. The quality of the documents was overall low, and the quality of the recommendations report has much to improve. There is also a lack of transparency about the quality of the evidence and the strength of the recommendations., Protocol Registration Number: CRD42020164899., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Previous primary studies have explored the association between blood pressure (BP) and mortality in ambulatory heart failure (HF) patients reporting varying and contrasting associations. The aim is to determine the pooled BP prognostic value and explore potential reasons for between-study inconsistency. We searched Medline, Cochrane, EMBASE and CINAHL from January 2005 to October 2018 for studies with ≥ 50 events (mortality and/or hospitalization) and included BP in a multivariable model in ambulatory HF patients. We pooled hazard ratios (random effects model) for systolic BP (SBP) or diastolic BP (DBP) effect on mortality and/or hospitalization risk. We used a priori defined sub-group analyses to explore heterogeneity and GRADE approach to assess the certainty of the evidence. Seventy-one eligible articles (239,467 screened) at low to moderate risk of bias included 235,752 participants. Higher SBP was associated with reduced all-cause mortality (HR 0.93, 95%CI 0.91-0.95, I 2  = 87.13%, moderate certainty), all-cause hospitalization events (HR 0.91, 95%CI 0.88-0.93, I 2  = 44.4%, high certainty) and their composite endpoint (HR 0.93 per 10 mmHg, 95%CI 0.91-0.94, I 2  = 86.3%, high certainty). DBP did not demonstrate a statistically significant effect for all outcomes. The association strength was significantly weaker in studies following patients with either LVEF > 40%, higher average SBP (> 130 mmHg), increasing age and diabetes. All other a priori subgroup hypotheses did not explain between study differences. Higher ambulatory SBP is associated with reduced risk of all-cause mortality and hospitalization. Patients with lower BP and reduced LVEF are in a high-risk group of developing adverse events with moderate certainty of evidence., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Prognostic models combine several prognostic factors to provide an estimate of the likelihood (or risk) of future events in individual patients, conditional on their prognostic factor values. A fundamental part of evaluating prognostic models is undertaking studies to determine whether their predictive performance, such as calibration and discrimination, is reproduced across settings. Systematic reviews and meta-analyses of studies evaluating prognostic models' performance are a necessary step for selection of models for clinical practice and for testing the underlying assumption that their use will improve outcomes, including patient's reassurance and optimal future planning., Methods: In this paper, we highlight key concepts in evaluating the certainty of evidence regarding the calibration of prognostic models., Results and Conclusion: Four concepts are key to evaluating the certainty of evidence on prognostic models' performance regarding calibration. The first concept is that the inference regarding calibration may take one of two forms: deciding whether one is rating certainty that a model's performance is satisfactory or, instead, unsatisfactory, in either case defining the threshold for satisfactory (or unsatisfactory) model performance. Second, inconsistency is the critical GRADE domain to deciding whether we are rating certainty in the model performance being satisfactory or unsatisfactory. Third, depending on whether one is rating certainty in satisfactory or unsatisfactory performance, different patterns of inconsistency of results across studies will inform ratings of certainty of evidence. Fourth, exploring the distribution of point estimates of observed to expected ratio across individual studies, and its determinants, will bear on the need for and direction of future research., (Copyright © 2021. Published by Elsevier Inc.)

Supervised machine learning (ML) is a class of algorithms that "learn" from existing input-output pairs, which is gaining popularity in pattern recognition for classification and prediction problems. In this scoping review, we examined the use of supervised ML algorithms for the prediction of long-term allograft survival in kidney transplant recipients. Data sources included PubMed, the Cumulative Index to Nursing and Allied Health Literature, and the Institute for Electrical and Electronics Engineers (IEEE) Xplore libraries from inception to November 2019. We screened titles and abstracts and potentially eligible full-text reports to select studies and subsequently abstracted the data. Eleven studies were identified. Decision trees were the most commonly used method (n = 8), followed by artificial neural networks (ANN) (n = 4) and Bayesian belief networks (n = 2). The area under receiver operating curve (AUC) was the most common measure of discrimination (n = 7), followed by sensitivity (n = 5) and specificity (n = 4). Model calibration examining the reliability in risk prediction was performed using either the Pearson r or the Hosmer-Lemeshow test in four studies. One study showed that logistic regression had comparable performance to ANN, while another study demonstrated that ANN performed better in terms of sensitivity, specificity, and accuracy, as compared with a Cox proportional hazards model. We synthesized the evidence related to the comparison of ML techniques with traditional statistical approaches for prediction of long-term allograft survival in patients with a kidney transplant. The methodological and reporting quality of included studies was poor. Our study also demonstrated mixed results in terms of the predictive potential of the models.

Objectives: Current guidelines mandate organ donation to be financially neutral such that it neither rewards nor exploits donors. This systematic review was conducted to assess the magnitude and type of costs incurred by adult living kidney donors and to identify those at risk of financial hardship., Methods: We searched English-language journal articles and working papers assessing direct and indirect costs incurred by donors on PubMed, MEDLINE, Scopus, the National Institute for Health Research Economic Evaluation Database, Research Papers in Economics, and EconLit in 2005 and thereafter. Estimates of total costs, types of costs, and characteristics of donors who incurred the financial burden were extracted., Results: Sixteen studies were identified involving 6158 donors. Average donor-borne costs ranged from US$900 to US$19 900 (2019 values) over the period from predonation evaluation to the end of the first postoperative year. Less than half of donors sought financial assistance and 80% had financial loss. Out-of-pocket payments for travel and health services were the most reported items where lost income accounted for the largest proportion (23.2%-83.7%) of total costs. New indirect cost items were identified to be insurance difficulty, exercise impairment, and caregiver income loss. Donors from lower-income households and those who traveled long distances reported the greatest financial hardship., Conclusions: Most kidney donors are undercompensated. Our findings highlight gaps in donor compensation for predonation evaluation, long-distance donations, and lifetime insurance protection. Additional studies outside of North America are needed to gain a global prospective on how to provide for financial neutrality for kidney donors., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: Resting heart rate is a risk factor of adverse heart failure outcomes; however, studies have shown controversial results. This meta-analysis evaluates the association of resting heart rate with mortality and hospitalization and identifies factors influencing its effect., Methods and Results: We systematically searched electronic databases in February 2019 for studies published in 2005 or before that evaluated the resting heart rate as a primary predictor or covariate of multivariable models of mortality and/or hospitalization in adult ambulatory patients with heart failure. Random effects inverse variance meta-analyses were performed to calculate pooled hazard ratios. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to assess evidence quality. Sixty-two studies on 163,445 patients proved eligible. Median population heart rate was 74 bpm (interquartile range 72-76 bpm). A 10-bpm increase was significantly associated with increased risk of all-cause mortality (hazard ratio 1.10, 95% confidence interval 1.08-1.13, high quality). Overall, subgroup analyses related to patient characteristics showed no changes to the effect estimate; however, there was a strongly positive interaction with age showing increasing risk of all-cause mortality per 10 bpm increase in heart rate., Conclusions: High-quality evidence demonstrates increasing resting heart rate is a significant predictor of all-cause mortality in ambulatory patients with heart failure on optimal medical therapy, with consistent effect across most patient factors and an increased risk trending with older age., Competing Interests: Declaration of Competing Interest The authors have no disclosures to any sources of conflicting interest, including Amgen., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study is to propose an approach for developing trustworthy recommendations as part of urgent responses (1-2 week) in the clinical, public health, and health systems fields., Study Design and Setting: We conducted a review of the literature, outlined a draft approach, refined the concept through iterative discussions, a workshop by the Grading of Recommendations Assessment, Development and Evaluation Rapid Guidelines project group, and obtained feedback from the larger Grading of Recommendations Assessment, Development and Evaluation working group., Results: A request for developing recommendations within 2 week is the usual trigger for an urgent response. Although the approach builds on the general principles of trustworthy guideline development, we highlight the following steps: (1) assess the level of urgency; (2) assess feasibility; (3) set up the organizational logistics; (4) specify the question(s); (5) collect the information needed; (6) assess the adequacy of identified information; (7) develop the recommendations using one of the 4 potential approaches: adopt existing recommendations, adapt existing recommendations, develop new recommendations using existing adequate systematic review, or develop new recommendations using expert panel input; and (8) consider an updating plan., Conclusion: An urgent response for developing recommendations requires building a cohesive, skilled, and highly motivated multidisciplinary team with the necessary clinical, scientific, and methodological expertise; adapting to shifting needs; complying with the principles of transparency; and properly managing conflicts of interest., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)

Rationale & Objectives: Due to unmeasured confounding, observational studies have limitations when assessing whether dialysis initiation reduces mortality compared with conservative therapy among adults with advanced chronic kidney disease (CKD). We addressed this issue in this meta-analysis., Study Design: Meta-analysis with bias analysis for unmeasured confounding., Setting & Study Population: Adults with stage 4 or 5 CKD who had initiated dialysis or conservative treatment., Selection Criteria for Studies: Prospective or retrospective cohort studies comparing survival of dialysis versus conservatively managed patients were searched on MEDLINE and Embase from January 2009 to March 20, 2019., Data Extraction: HRs of all-cause mortality associated with dialysis initiation compared with conservative treatment., Analytical Approach: We pooled HRs using a random-effects model. We estimated the percentage of effect sizes more protective than HRs of 0.80 and severity of unmeasured confounding that could reduce this percentage to only 10%. Subgroup analysis was performed for studies with only older patients (aged ≥ 65 years)., Results: 12 studies were included that involved 16,609 dialysis patients and 3,691 conservatively managed patients. A random-effects model suggested that dialysis initiation was associated with a mean mortality HR of 0.47 (95% CI, 0.34-0.64), in which 92% (95% CI, 50%-100%) of the true effects were more protective than HRs of 0.80. To reduce the percentage of HRs < 0.80 to 10%, unmeasured confounder(s) would need to be associated with both dialysis initiation and mortality by relative risks of 4.05 (95% CI, 2.39-4.15), which is equivalent to shifting each study's estimated HR by 2.31-fold (95% CI, 1.51-2.36). Restricting studies to include only older patients did not modify the results., Limitations: Limited number of studies and evidence on the absence of publication bias., Conclusions: Our findings suggest that dialysis initiation considerably reduces mortality among adults with advanced CKD. Future bias-adjusted meta-analyses need to assess outcomes beyond mortality., (© 2020 The Authors.)

Deceased-donor renal transplant (DDRT) is an expensive and potentially risky health intervention with the prospect of improved life and lower long-term costs compared with dialysis. Due to the increasing shortage of kidneys and the associated rise of transplantation costs, certain patient groups may not benefit from transplantation in a cost-effective manner compared with dialysis. The objective of this systematic review was to provide a comprehensive synthesis of evidence on the cost-effectiveness of DDRT relative to dialysis to treat adults with end-stage renal disease and patient-, donor-, and system-level factors that may modify the conclusion. A systematic search of articles was conducted on major databases including MEDLINE, Embase, Scopus, EconLit, and the Health Economic Evaluations Database. Eligible articles were restricted to those published in 2001 or thereafter. Two reviewers independently assessed the suitability of studies and excluded studies that focused on recipients with age <18 years old and those of a living-donor or multiorgan transplant. We show that while DDRT is generally a cost-effective treatment relative to dialysis at conventional willingness-to-pay thresholds, a range of drivers including older patient age, comorbidity, and long wait times significantly reduce the benefit of DDRT while escalating healthcare costs. These findings suggest that the performance of DDRT on older patients with comorbidities should be carefully evaluated to avoid adverse results as evidence suggests that it is not cost-effective. Delayed transplantation may reduce the economic benefits of transplant which necessitates targeted policies that aim to shorten wait times. More recent findings have demonstrated that transplantation using high-risk donors may be a cost-effective and promising alternative to dialysis in the face of a lack of organ availability and fiscal constraints. This review highlights key concepts of health economic evaluations and the relevance of cost-effectiveness to inform care and decision-making in renal programs., Competing Interests: The authors declare no funding or conflicts of interest., (Copyright © 2020 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.)

Objective: The objective of the study was to clarify how the Grading of Recommendations Assessment, Development and Evaluation (GRADE) concept of certainty of evidence applies to certainty ratings of test accuracy., Study Design and Setting: After initial brainstorming with GRADE Working Group members, we iteratively refined and clarified the approaches for defining ranges when assessing the certainty of evidence for test accuracy within a systematic review, health technology assessment, or guideline., Results: Ranges can be defined both for single test accuracy and for comparative accuracy of multiple tests. For systematic reviews and health technology assessments, approaches for defining ranges include some that do not require value judgments regarding downstream health outcomes. Key challenges arise in the context of a guideline that requires ranges for sensitivity and specificity that are set considering possible effects on all critical outcomes. We illustrate possible approaches and provide an example from a systematic review of a direct comparison between two test strategies., Conclusions: This GRADE concept paper provides a framework for assessing, presenting, and making decisions based on the certainty of evidence for test accuracy. More empirical research is needed to support future GRADE guidance on how to best operationalize the candidate approaches., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: Diabetic kidney disease (DKD) is an independent predictor of cardiovascular morbidity and mortality in type 1 diabetes (T1D). We aimed to explore clinical and biochemical factors, including the achievement of American Diabetes Association (ADA) recommended targets associated with DKD in people living with T1D for ≥50 years. Methods: This was a post hoc analysis of a cross-sectional study of 75 participants enrolled in the Canadian Study of Longevity in T1D. We explored diabetes-related complications, including neuropathy, retinopathy, cardiovascular disease, and DKD. Study participants were dichotomized based on the achievement of ADA recommended targets as the low-target group (achieving ≤4 targets, n  = 31) and high-target group (achieving >4 targets, n  = 44). The outcome of interest was DKD defined by estimated glomerular filtration rate (eGFR) values <60/mL/min/1.73 m 2 and/or 24-h albumin excretion >30 mg. Multivariable logistic regression models were employed to estimate odds ratios (ORs) for DKD with 95% confidence intervals (CIs). Results: Of the 75 participants with prolonged T1D duration (45% male, mean age 66 years), 25 participants had DKD and 50 did not. There was no statistical difference between the high- and low-target groups in terms of age and body mass index. eGFR was significantly higher and the prevalence of diabetic retinopathy was significantly lower in the high-target group. Older age at diagnosis of T1D and lower frequency component to high-frequency component ratio increased the odds of having DKD. Conclusions: In adults with prolonged T1D duration, older age at diagnosis and lower heart rate variability may be associated with DKD.

Health systems guidance (HSG) documents contain systematically developed statements or recommendations intended to address a health system challenge. The concept of HSG is fairly new and considerable effort has been undertaken to build tools to support the contextualization of recommendations. One example is the Appraisal of Guidelines for REsearch and Evaluation - Health Systems (AGREE-HS), created by international stakeholders and researchers, to assist in the development, reporting and evaluation of HSG. Here, we present the quality appraisal of 85 HSG documents published from 2012 to 2017 using the AGREE-HS. The AGREE-HS consists of five items (Topic, Participants, Methods, Recommendations, and Implementability), which are scored on a 7-point response scale (1=lowest quality; 7=highest quality). Overall, AGREE-HS item scores were highest for the 'Topic' and 'Recommendations' items (means above the mid-point of 4), while the 'Participants', 'Methods', and 'Implementability' items received lower scores. Documents without a specific health focus and those authored by the National Institute for Health and Care Excellence group, achieved higher AGREE-HS overall scores than their comparators. No statistically significant changes in overall scores were observed over time. This is the first time that the AGREE-HS has been applied, providing a current quality status report of HSG and identifying where improvements in HSG development and reporting can be made., (Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: Coverage decisions in publicly funded healthcare systems require a formal, systematic and transparent assessment process for policies related to distribution of resources. The process is complex and employs multiple types of information, such as clinical effectiveness, costs and health utility scores which are used to produce quality-adjusted life years. The purpose of this study was to create health utility scores for CKD patients within the Canadian population., Methods: This is a cross-sectional study of CKD patients. We administered the Short-Form 36 Quality of Life Questions to all participants and employed the Short-Form 6 Dimension index to create health utility scores which were created using a set of parametric preference weights, nonparametric preference weights and ordinal health state valuation techniques obtained from a sample of the general population., Results: Utility values in the dialysis group were lower than in the non-dialysis group. There was a significant relationship between age and health utility scores: As age increases, health utility scores decrease. Diabetes was associated with lower health utility scores in dialysis patients, whereas other covariates did not reach levels of statistical significance in our stepwise regression models. The parametric Bayesian model and standard gamble approach yielded the same results, while the correlation between the nonparametric and parametric methods was above 0.9., Conclusion: Health utility scores were low relative to the general population norm in our study cohort. Longitudinal assessment of CKD patients to capture possible fluctuations in health utility scores may add useful information.

Background: Chronic kidney disease-mineral and bone disorder (CKD-MBD), a complication of chronic kidney disease, has been linked to reduced quality and length of life. High serum phosphate levels that result from CKD-MBD require phosphate-lowering agents, also known as phosphate binders. The objective of this systematic review is to compare the effects of available phosphate binders on laboratory outcomes in patients with CKD-MBD., Methods: Data sources included MEDLINE and EMBASE from January 1996 to April 2016, and the Cochrane Register of Controlled Trials up to April 2016. Teams of two reviewers, independently and in duplicate, screened titles and abstracts and potentially eligible full text reports to determine eligibility, and subsequently abstracted data and assessed risk of bias in eligible randomized controlled trials (RCTs). Eligible trials enrolled patients with CKD-MBD and randomized them to receive calcium-based phosphate binders (delivered as calcium acetate, calcium citrate or calcium carbonate), non-calcium-based phosphate binders (NCBPB) (sevelamer hydrochloride, sevelamer carbonate, lanthanum carbonate, sucroferric oxyhydroxide and ferric citrate), phosphorus restricted diet (diet), placebo or no treatment and reported effects on serum levels of phosphate, calcium and parathyroid hormone. We performed Bayesian network meta-analyses (NMA) to calculate the effect estimates (mean differences) and 95% credible intervals for serum levels of phosphate, calcium and parathyroid hormone. We calculated direct, indirect and network meta-analysis estimates using random-effects models. We applied the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to rate the quality of evidence for each pairwise comparison., Results: Our search yielded 1108 citations; 71 RCTs were retrieved for full review and 16 proved eligible. Including an additional 13 studies from a previous review, 29 studies that enrolled 8335 participants proved eligible; 26 trials provided data for quantitative synthesis. Sevelamer, lanthanum, calcium, iron, diet and combinations of active treatments (calcium or sevelamer or lanthanum and combination of calcium and sevelamer) resulted in significantly lower serum phosphate as compared to placebo (moderate to very low quality of evidence). We found no statistically significant differences between active treatment categories in lowering serum phosphate. Sevelamer, lanthanum and diet resulted in lower serum calcium compared to calcium (moderate quality evidence for lanthanum and diet; low quality evidence for Sevelamer). Iron, sevelamer and calcium yielded lower parathyroid hormone levels as compared to lanthanum. Meta-regression analyses did not yield a statistically significant association between treatment effect and trial duration., Discussion/conclusions: We found few differences between treatments in impact on phosphate and differences in parathyroid hormone. Relative to calcium, sevelamer, lanthanum and diet showed significant reduction in serum calcium from baseline. Treatment recommendations should be based on impact on patient-important outcomes rather than on surrogate outcomes. Systematic review registration: PROSPERO CRD-42016032945.

Background: Patients with chronic kidney disease mineral and bone disorders (CKD-MBD) suffer high rates of morbidity and mortality, in particular related to bone and cardiovascular outcomes. The management of CKD-MBD remains challenging. The objective of this systematic survey is to critically appraise clinical practice guidelines (CPGs) addressing CKD-MBD., Methods/design: Data sources included MEDLINE, EMBASE, the National Guideline Clearinghouse, Guideline International Network and Turning Research into Practice up to May 2016. Teams of two reviewers, independently and in duplicate, screened titles and abstracts and potentially eligible full text reports to determine eligibility and subsequently appraised the guidelines using the Advancing Guideline Development, Reporting and Evaluation in Health Care instrument II (AGREE)., Results: Sixteen CPGs published from 2003 to 2015 addressing the diagnosis and management of CKD-MBD in adult patients (11 English, two Spanish, one Italian, one Portuguese and one Slovak) proved eligible. The National Institute for Health and Care Excellence guideline performed best with respect to AGREE II criteria; only three other CPGs warranted high scores on all domains. All other guidelines received scores of under 60% on one or more domains. Major discrepancies in recommendations were not, however, present, and we found no association between quality of CPGs which was not associated with resulting recommendations., Conclusions: Most guidelines assessing CKD-MBD suffer from serious shortcomings using AGREE criteria although limitations with respect to AGREE criteria do not necessarily lead to inappropriate recommendations.

Objectives: To explore the responsiveness of patient-reported outcomes (PROs) in interventional studies involving patients with rare lysosomal storage diseases (LSDs)., Study Design and Setting: We searched eight databases for experimental and nonexperimental studies. Pairs of trained reviewers independently screened articles and subsequently extracted data from the eligible studies. Among studies with 10 or more patients using a valid PRO, we assessed the responsiveness of PROs based on a reanalysis of the data using minimal important difference estimates. Our analyses focused on statistically significant within-group differences in PROs for observational studies or the statistically significant between-group differences in PRO scores for controlled studies., Results: Of 2,679 unique records, 62 interventional studies addressing patients with Fabry (55%), Gaucher (19%), Pompe (16%), and mucopolysaccharidoses (11%) proved eligible. The most frequently used PROs were the Short-Form-36 (25 studies), Brief Pain Inventory (20 studies), EuroQoL-5D (9 studies), and the Fatigue Severity Scale (6 studies). Observational studies suggest that PROs sometimes detect significant within-group changes when present. Randomized trials raise questions regarding the responsiveness of PROs to small differences between groups., Conclusions: Most studies have relied on generic PROs to evaluate quality of life and symptoms in patients with rare LSDs. PROs appear more responsive in observational studies than randomized trials., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Chronic kidney disease-mineral and bone disorders (CKD-MBD) have been associated with poor health outcomes, including diminished quality and length of life. Standard management for CKD-MBD includes phosphate restricted diet, vitamin D and phosphate binders. Persistently elevated parathyroid hormone levels may require the addition of cinacalcet hydrochloride (cinacalcet), which sensitizes calcium receptors in the parathyroid gland., Purpose: The objective of this systematic review is to compare, in patients with CKD-MBD the effect of cinacalcet versus standard treatment on patient-important outcomes, including parathyroidectomy, fractures, hospitalizations due to cardiovascular events, cardiovascular mortality, all-cause mortality, and intermediate outcomes, in particular Kidney Disease Outcome Quality Initiative targets., Methods: Data sources included MEDLINE, EMBASE, the Cochrane Register of Controlled Trials and Web of Science from 1996 to June 2015. Teams of two reviewers, independently and in duplicate, screened titles and abstracts and potentially eligible full text reports to determine eligibility, and subsequently abstracted data and assessed risk of bias in eligible trials. We calculated the effect estimates (risk ratios or mean differences) and 95% confidence intervals, as well as statistical measures of variability in results across studies using random effect models. We used the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to rate quality of evidence about estimates of effect on an outcome-by-outcome basis for all outcomes. We presented our results with a GRADE summary table., Results: Twenty-four trials including 8311 CKD patients proved eligible. The results left considerable uncertainty regarding the impact of cinacalcet on reducing fractures (relative risk [RR] 0.59, 95% confidence interval [CI] 0.13-2.60; heterogeneity: p = 0.03, I(2)= 78%; very low quality evidence), and indicated that cinacalcet did not reduce hospitalizations due to cardiovascular events (RR 0.93, 95% CI 0.85-1.02, moderate quality of evidence), cardiovascular mortality (RR 0.95, 95% CI 0.84-1.07; heterogeneity p= 0.61, high quality evidence) or all-cause mortality (RR 0.96, 95% CI 0.89-1.04; heterogeneity: p= 0.98, I(2)= 0%; moderate quality evidence). Cinacalcet reduced the need for parathyroidectomy (RR 0.30, 95% CI 0.22-0.42; heterogeneity: p= 0.70, I(2)= 0%; absolute effect 55 fewer per 1000 [95% CI 61 fewer to 45 fewer], high quality of evidence). The most common adverse event associated with cinacalcet therapy was gastrointestinal side effects. Cinacalcet increased nausea (RR 2.16, 95% CI 1.46-3.21, absolute effect 158 more per 1000 [95% CI 82 more to 302 more]) and vomiting (RR 2.15, 95% CI 1.66-2.80, absolute effect 63 more per 1000 [95% CI 109 more to 171 more]). Cinacalcet treatment increased the rate of hypocalcemia (RR 6.0, 95% CI 3.65-9.87; heterogeneity: p= 0.71, I(2)= 0%, absolute effect 20 more per 1000 [95% CI 11 more to 36 more], high quality of evidence)., Conclusions: In the hands of clinicians participating in these studies, cinacalcet decreased the rate of parathyroidectomy but had no influence on mortality. Patients and clinicians can trade of the benefit of fewer parathyroidectomies against the adverse effects.

Background: Chronic kidney disease-mineral and bone disorder (CKD-MBD) has been linked to poor health outcomes, including diminished quality and length of life. This condition is characterized by high phosphate levels and requires phosphate-lowering agents-phosphate binders. The objective of this systematic review is to compare the effects of available phosphate binders on patient-important outcomes in patients with CKD-MBD., Methods: Data sources included MEDLINE and EMBASE Trials from 1996 to February 2016. We also searched the Cochrane Register of Controlled Trials up to April 2016. Teams of two reviewers, independently and in duplicate, screened titles and abstracts and potentially eligible full text reports to determine eligibility, and subsequently abstracted data and assessed risk of bias in eligible randomized controlled trials (RCTs). Eligible trials enrolled patients with CKD-MBD, randomized them to receive calcium (delivered as calcium acetate, calcium citrate or calcium carbonate), non-calcium-based phosphate binders (NCBPB) (sevelamer hydrochloride, sevelamer carbonate, lanthanum carbonate, sucroferric oxyhydroxide and ferric citrate), phosphorus restricted diet, placebo or no treatment, and reported effects on all-cause mortality, cardiovascular mortality or hospitalization at ≥4 weeks follow-up. We performed network meta-analyses (NMA) for all cause-mortality for individual agents (seven-node analysis) and conventional meta-analysis of calcium vs. NCBPBs for all-cause mortality, cardiovascular mortality and hospitalization. In the NMAs, we calculated the effect estimates for direct, indirect and network meta-analysis estimates; for both NMA and conventional meta-analysis, we pooled treatment effects as risk ratios (RR) and calculated 95% confidence intervals (CIs) using random effect models. We used the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to rate the quality of evidence for each paired comparison., Results: Our search yielded 1190 citations, of which 71 RCTs were retrieved for full review and 15 proved eligible. With 13 eligible studies from a prior review, we included 28 studies with 8335 participants; 25 trials provided data for our quantitative synthesis. Results suggest higher mortality with calcium than either sevelamer (NMA RR, 1.89 [95% CI, 1.02 to 3.50], moderate quality evidence) or NCBPBs (conventional meta-analysis RR, 1.76 [95% CI, 1.21 to 2.56, moderate quality evidence). Conventional meta-analysis suggested no difference in cardiovascular mortality between calcium and NCBPBs (RR, 2.54 [95% CI, 0.67 to 9.62 low quality evidence). Our results suggest higher hospitalization, although non-significant, with calcium than NCBPBs (RR, 1.293 [95% CI, 0.94 to 1.74, moderate quality evidence)., Discussion/conclusions: Use of calcium results in higher mortality than either sevelamer in particular and NCBPBs in general (moderate quality evidence). Our results raise questions about whether administration of calcium as an intervention for CKD- MBD remains ethical. Further research is needed to explore the effects of different types of phosphate binders, including novel agents such as iron, on quality and quantity of life., Systematic Review Registration: PROSPERO CRD-42016032945.

Background: Chronic kidney disease-mineral and bone disorders (CKD-MBD) have been associated with poor health outcomes, including diminished quality and length of life. Standard management for CKD-MBD includes phosphate-restricted diet, active vitamin D, vitamin D analogs, and phosphate binders. Persistently elevated parathyroid hormone (PTH) levels may require the addition of Cinacalcet hydrochloride (cinacalcet) which sensitizes calcium receptors on the parathyroid glands. The objective of this systematic review is to compare the effect of cinacalcet versus standard treatment in patients with CKD-MBD., Methods/design: Data sources will include MEDLINE, EMBASE, the Cochrane Register of Controlled Trials, and Web of Science from 1996 to June 2015. Teams of two reviewers will, independently and in duplicate, screen titles and abstracts and potentially eligible full text reports to determine eligibility, and subsequently abstract data and assess risk of bias in eligible trials. We will calculate the effect estimates (risk ratios or mean differences) and 95 % confidence intervals, as well as statistical measures of variability in results across studies using random effect models for patient-important and intermediate outcomes. We will use the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to rate the quality of evidence about estimates of effect on an outcome-by-outcome basis. We will present our results with a GRADE summary table., Discussion: Our review will explore the effect of cinacalcet versus standard treatment in patients with CKD-MBD. The results of this systematic review will help guide management of this patient population, and identify targets for future research., Systematic Review Registration: PROSPERO CRD42015020318 http://www.crd.york.ac.uk/PROSPERO/display&#95;record.asp?ID=CRD42015020318.

Background: Guidelines suggest percutaneous intervention (PCI) of only the culprit artery in patients presenting with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease. However, recent randomized controlled trials (RCTs) suggest benefit to performing PCI of other stenotic vessels at the same time as culprit vessel PCI., Methods: We conducted a systematic review with complete case meta-analysis and sensitivity analyses. Data sources included MEDLINE, EMBASE, Cochrane Register of Controlled Trials, and CINAHL from 1946 to March 2014; MEDLINE and EMBASE from March 2014 to March 2015; and scanning of literature for new studies until August 2015. All RCTs comparing multivessel versus culprit-only PCI in patients with STEMI were eligible. The primary outcomes of interest were recurrent myocardial infarction (MI), recurrent revascularization, and mortality. We combined data from trials to estimate the pooled risk ratio (RR) and associated 95% CIs using random-effects models., Results: Five RCTs including 1,606 patients of whom 1,568 had complete data proved eligible. Multivessel revascularization was associated with decreased risk of repeat revascularization (RR 0.36, 95% CI 0.27-0.49, risk difference 9.7% over 2 years) and recurrent nonfatal MI (RR 0.58, 95% CI 0.36-0.93, risk difference 1.8% over 2 years), without increase in mortality (RR 0.82, 95% CI 0.53-1.26) or other adverse events., Conclusions: Pooled data provide moderate-certainty evidence that performance of multivessel PCI will provide an appreciable reduction in nonfatal MI and high-certainty evidence that it will reduce need for repeat revascularization. Patients are likely to place a high value on these benefits., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose: Since sympathovagal imbalance influences clinical phenomena, such as hypertension, diabetes mellitus, chronic kidney disease (CKD) and sleeping problems, there should be correlations between these conditions. We hypothesized that sleep quality would be correlated with estimated glomerular filtration rate (eGFR), blood pressure and the presence of diabetes., Methods: We included 303 CKD patients in this study. We employed the Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI) and Short Form 36 Quality of Life Health Survey Questions (SF-36) to screen sleeping disturbances, depression and quality of life, respectively. A chart review was performed for the patients' demographics, diagnoses and certain laboratory parameters--including blood glucose, hemoglobin, albumin, calcium, phosphate, parathyroid hormone and eGFR. Multivariate logistic regression models were employed to estimate odds ratios with 95% confidence intervals., Results: We included 303 patients in this cross-sectional study. A total of 101 patients were on dialysis. In the univariate models, gender, calcium and mental component summary scores (MCS) reached a significant level of 0.1, and those covariates were included in the multivariate analysis. The reduced models included gender and MCS categories. Female gender increases the risk for poor sleep quality. In our report, evidence suggests MCS domain scores are inversely related to the risk for impaired sleep., Conclusion: Our results indicated a high burden of sleep disturbances in kidney patients. In addition, female gender and having low MCS scores may influence sleep quality in kidney patients.

Purpose: The primary objective of this cross-sectional study was to test factors associated with sleep apnea in patients with chronic kidney disease (CKD). The prevalence of sleep apnea was also assessed., Methods: We recruited patients with CKD Stage 3-5 who lived in the St. John's area from September 2012 to December 2012. The Berlin Questionnaire and Short Form 36 Quality of Life Health Survey Questions (SF-36) were administered to all participants., Results: We recruited 303 patients (41% female). A total of 157 (51.8%) patients had a high risk for sleep apnea. Higher body mass index and young age were correlated with sleep apnea. Physical component score of SF-36 (PCS) tested as a continuous variable indicated a significant association with the risk for sleep apnea (OR: 0.97, 95% CI: 0.94-0.99, p = 0.03). The association implies 3% change per one point increase in PCS. We categorized mental component score of SF-36 (MCS) into four quartiles, as the linearity assumption was violated. There was a 61% risk increase for poor sleep in those with an MCS score less than the 75th percentile, when compared to those above the 75th percentile (OR: 0.39, 95% CI: 0.21-0.71, p = 0.002)., Conclusions: Sleep apnea is common in kidney patients. People who have low PCS and MCS scores are more prone to sleep apnea or vice versa. Our results also indicate that high BMI and young age are associated with sleep apnea.

Although multivessel coronary artery disease has been associated with poor health outcomes in patients with acute ST-segment elevation myocardial infarction (STEMI), the optimal approach to revascularization remains uncertain. The objective of this review was to determine the benefits and harms of culprit vessel only vs immediate complete percutaneous coronary intervention (PCI) in patients with acute STEMI. We searched MEDLINE, EMBASE, the Cochrane Register of Controlled Trials, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) for randomized controlled trials (RCTs). Teams of 2 reviewers, independently and in duplicate, screened titles and abstracts, completed full-text reviews, and abstracted data. We calculated pooled risk ratios (RRs) and associated 95% confidence intervals (CIs) using random-effect models for nonfatal myocardial infarction (MI), revascularization, cardiovascular mortality, all-cause mortality, and adverse events, and used the GRADE approach to rate confidence in estimates of effect. Of 341 patients randomized to complete revascularization and followed to study conclusion, 31 experienced revascularization, as did 80 of 324 randomized to culprit vessel only revascularization (RR: 0.35, 95% CI: 0.24-0.53). Ten patients in the complete revascularization group and 28 patients in the culprit vessel only revascularization group experienced nonfatal MI (RR: 0.35, 95% CI: 0.17-0.72). All-cause mortality and cardiac deaths did not differ between groups (RR: 0.69, 95% CI: 0.40-1.21 for all-cause mortality; RR: 0.48, 95% CI: 0.22-1.04 for cardiac deaths). Pooled data from 3 RCTs suggest that immediate complete revascularization probably reduces revascularization in patients with acute STEMI; although results suggest possible benefits on MI and death, confidence in estimates is low., (© 2014 Wiley Periodicals, Inc.)

Background: Hyponatremia in peritoneal dialysis (PD) patients has previously been associated with water overload and weight gain, or with malnutrition and intracellular potassium depletion. Although there is a sizable literature about transmembrane sodium and water removal in PD, there are few reports about the incidence and characteristics of hyponatremia in the clinical setting., Aim: We evaluated the incidence and factors associated with hyponatremia in PD patients in a single PD unit., Methods: We retrospectively evaluated the records of all patients (n = 198) who were treated with PD in the Home PD Unit of the University Health Network at Toronto General Hospital during 2010. We identified 166 patients who had a minimum follow-up of 60 days during 2010 and at least 2 consecutive sodium measurements at least a month apart. We examined baseline differences between patients who developed hyponatremia and those who did not, and clinical and biochemical factors that correlated with mean sodium values. In the 24 patients who developed hyponatremia, we examined paired differences between the normonatremic and hyponatremic periods. Finally, we investigated any possible correlations of change in serum sodium with clinical and biochemical characteristics before and during the hyponatremic period., Results: The incidence of hyponatremia was 14.5%. In multivariate analysis, serum sodium correlated significantly and independently with residual renal function (RRF: r = 0.463, p = 0.0001) and negatively with the daily volume of instilled icodextrin (r = -0.476, p = 0.0001). Residual renal function was significantly lower in patients with hyponatremia than in those with normal serum sodium (1.97 ± 2.3 mL/min vs 4.31 ± 5.01 mL/min, p = 0.033). The mean paired difference in body weight was -1.113 kg and the median difference was -0.55 kg (range: -8.5 kg to +4.2 kg). Impressively, hyponatremia was not associated with an increase in body weight in most patients who developed this complication (13 of 16 for whom comparative weights were known). Moreover, the mean paired change in serum sodium (ΔNa) from normonatremia to hyponatremia was, contrary to our expectations, significantly correlated with a decrease in body weight (r = 0.584, p = 0.017). The ΔNa was also significantly correlated with serum potassium (r = 0.526, p = 0.008), the greatest drop in serum sodium being associated with lower serum potassium in the hyponatremic period, as predicted., Conclusions: Hyponatremia is seen more often than expected in a clinical setting. Serum sodium is strongly correlated with RRF, hyponatremia being associated with lower RRF. In patients who experienced hyponatremia, the fall in serum sodium was associated with a decrease, not an increase, in body weight and was correlated with serum potassium, suggesting that sodium and potassium depletion-and, by inference, malnutrition-may be important contributors in the clinical setting., (Copyright © 2014 International Society for Peritoneal Dialysis.)

Background: The incidence of obesity is increasing both in the general population and in incident dialysis patients. While there is evidence that being overweight is associated with good outcomes in hemodialysis, the evidence in peritoneal dialysis (PD) patients is not very clear. We studied a modern cohort of PD patients to examine outcomes in large patients., Methods: Forty-three patients who started PD, who weighed more than 90 kg at dialysis initiation, between January/2000 and June/2010 were matched with 43 control patients who weighed less than 90 kg. Detailed review of the charts was undertaken., Results: The mean weight and body mass index of the wt < 90 kg group were 69.3 ± 11.3 kg and 25.0 ± 3.9 kg/m(2). The number of peritonitis episodes per year was 0.33 ± 0.6 (wt < 90 kg) and 0.82 ± 1.7 (wt ≥ 90 kg) (p = 0.26). The median time to first peritonitis showed a trend toward earlier peritonitis in larger patients [9.5 (4.3, 27) months in wt ≥ 90 kg, 19.1(7.9, 30.8) months in wt < 90 kg] but did not reach statistical significance (p = 0.12). Surprisingly, hernias and leaks were more common in the weight <90 kg group (44 vs. 18.6 % p = 0.02). There was no difference in total number of hospitalizations or the number of days hospitalized. Kaplan-Meier analysis of survival on PD showed no differences between the two groups (logrank p = 0.99). Cox regression analysis using age, race, cause of ESRD due to diabetes and Charlson comorbidity index as the covariates did not show weight to be associated with survival on PD., Conclusions: Large patients tend to do just as well on PD, with survival on PD being no different compared to individuals with lower weight and body mass index.

Purpose: The optimal target for glycated hemoglobin (HbA1c) has not been well defined in peritoneal dialysis (PD) patients with diabetes mellitus., Methods: The objective of our study was to examine the predictive value of predialysis and time-averaged follow-up HbA1c values on technique and patient survival in diabetic PD patients treated in the Toronto General Hospital Home Peritoneal Dialysis Unit, between January 1, 2003 and December 31, 2008 with a median follow-up period of 30±23 months., Results: Ninety-one patients (mean age 64±13 years-old) were included in this retrospective study. Patients were followed between 3 and 91 months (mean duration 30±23 months). During this period, 40 patients died. We found no statistically significant correlation between baseline predialysis HbA1c values and technique and patient survival. Time-averaged follow-up HbA1c in increments<6.5%, 6.5-8%, and >8% showed no significant survival difference among groups., Conclusions: There was no significant correlation of baseline and time-averaged follow-up HbA1c values with patient and PD technique survival.

Paragangliomas of the head and neck are highly vascular lesions originating from paraganglionic tissue located at the carotid bifurcation (carotid body tumors), along the vagus nerve (vagal paragangliomas), and in the jugular fossa and tympanic cavity and should be considered in the evaluation of all lateral neck masses. The aim of this study was to review an institutional experience in the management of jugular paragangliomas. Thirteen jugular paragangliomas (Fisch classifications C and D glomus jugulare) were treated in our institution during a period of 5 years (2003-2008). All patients with adequate follow-up and complete records (13 cases) were reviewed with emphasis on the results of surgical management and the factors influencing them. Coupled with the residual tumors in 2 patients, the surgical control achieved was 82%. No recurrence was seen. All patients were subjected to digital subtraction angiography to define the vascular supply of the tumor. Microcoil embolization of 11 jugular paragangliomas (all [100%] of the patients who accepted the operation) was performed during the initial digital subtraction angiography. There was no perioperative mortality. There was one case of perioperative cerebrospinal fluid leak, which was repaired during the surgery. The facial nerve was preserved in all of the patients. The overall preservation rate of lower cranial nerves was 54% (7 of 13). Two patients with residual jugular paraganglioma were posttreated with irradiation (gamma knife) owing to skull base extension with significant symptomatic relief. Two patients who refused the surgical treatment were managed by stereotactic radiosurgery. The primary therapeutic option for jugular paragangliomas is complete excision of tumor with preservation of vital neurovascular structures. The combined therapeutic approach with preoperative selective embolization followed by surgical resection is the safe and effective method for complete excision of tumors with a reduced morbidity rate. Irradiation (gamma knife) is an effective therapy method for residual jugular paraganglioma.

Kimura disease (KD) is a chronic inflammatory disorder with unknown etiology, most commonly manifesting as painless unilateral cervical lymphadenopathy or subcutaneous masses in the head or neck region. Kimura disease is an unusual vascular tumor that typically occurs at 20 to 30 years of age, more commonly in women. There has been no documented case of malignant transformation; however, recurrence rates after excision may be as high as 25%. Surgery and medical therapy are useful for treatment. We present a 28-year-old man developed a unilateral cervical mass associated with KD. We made a complete excisional resection of the mass. We could not see any evidence of relapsing and decided that proper surgical resection of the lesion can be a treatment for KD. Because the disease can be seen with nephritic syndrome and has different treatment options, the otolaryngology specialist should consider KD in patients with neck mass and eosinophilia.

Objective: Composite nasal septal cartilage grafts (CNSCG) are effective grafting materials in laryngeal and tracheal reconstruction following tumor resection., Methods: Between 1985 and 2005, we used CNSCG for the reconstruction of defects following resection of laryngeal tumors with subglottic extension (20 cases), subglottic mesenchymal tumors (2 cases), invasive thyroid carcinoma (4 cases), tracheal tumors (3 cases) and esophagus carcinoma with tracheal invasion (1 case) in total of 30 patients., Results: The patients with subglottic tumors were decanulated within 5-7 days except one case. We achieved satisfactory voice and swallowing without any sign of recurrence. Overall complications consisted of subglottic stenosis in one case, and unilateral paralysis of recurrent laryngeal nerve in two cases. One patient with subglottic laryngeal carcinoma died due to neck and distant metastases 4 years after the operation. All patients are well with a mean follow-up period 9 years. Three patients with tracheal tumors underwent lateral resection and reconstructed with CNSCG. Satisfactory healing of the grafts was seen in all cases without local recurrence or complication with a mean follow-up period of 62 months. One of the patients had distant metastases 3 years after the operation. The patient with esophagus carcinoma and tracheal invasion was treated by total esophagectomy, gastric pull-up, tracheal resection and CNSCG reconstruction. He died at postoperative 5th day due to mediastinitis as a complication of gastric pull-up., Conclusion: Free composite cartilage graft is a reliable material in the reconstruction of defects after surgery of laryngeal tumors with subglottic extension, invasive thyroid and esophagus tumors and well-selected tracheal tumors.

Objective: To determine the predictive value of endoscopic examination and radiological imaging in the evaluation of substomal tracheomalacia in advanced laryngotracheal stenosis., Methods: Forty nine patients with advanced laryngotracheal stenosis were preoperatively evaluated with radiological (magnetic resonance imaging [MRI]) and endoscopy to determine the grade of laryngotracheal stenosis and presence of substomal tracheomalacia. The intraoperative findings were compared with the preoperative findings, and the percentage of operative plan changes was calculated., Results: In a preoperative evaluation, 37 patients were found to have no substomal tracheomalacia; but during the surgical procedure, we detected substomal tracheomalacia in 12 (32.4%) of these patients and changed our preoperative plan during the procedure (p < 0.05)., Conclusion: Laryngotracheal reconstruction plans are dependent on preoperative evaluations which can change significantly during the surgical procedure. Therefore, experienced physicians who can alter the preoperative plan immediately during the procedure and successfully perform an alternative procedure are necessary.

The aim of this study was to evaluate the oxidative DNA damage, antioxidant activity, and effects of antihypertensive drugs on oxidative stress in hypertensive patients with different stages of chronic kidney disease (CKD). Fifty-three non-dialyzed hypertensive CKD patients were included by the study. Serum and urinary 8-hydroxydeoxy guanosine (8-OHdG) levels (as a marker of oxidative DNA damage), serum superoxide dismutase (SOD), and glutathione peroxidase (G-Px) activities (as antioxidant enzymes) were measured. SOD activity was higher and G-Px activity was lower in the patient group as compared to control group. Serum and urinary 8-OHdG levels were found to be higher in the patients with proteinuria greater than 3 g/day than those in the patients with proteinuria less than 3 g/day. It has been determined that G-Px activity and urinary 8-OHdG level were lower in the patients treated with angiotensin-converting enzyme (ACE) inhibitor compared to patients treated with calcium channel blocker. The present data show oxidative DNA damage at a higher level in the patients with proteinuria greater than 3 g/day. In comparison to a calcium channel blocker, an ACE inhibitor seems much more protective against oxidative DNA damage in hypertensive patients with different stages of CKD.

Objectives: Despite significant improvements in renal management the mortality associated with dialysis care remains high. Many renal registries report mortality statistics on an annual basis. The objectives of this study were (1) to establish the accuracy of the registered cause of death (CoD) against that determined by a panel of physicians; and (2) to test the feasibility of using the HEMO study CoD classification system in patients on peritoneal dialysis (PD)., Setting: Single centre tertiary-care hospital., Patients and Methods: Patients were selected from those aged > or = 65 years who died while receiving PD. The CoD was identified from that registered with the local renal registry, and from clinical records., Main Outcome Measures: (1) Sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV) and kappa score comparing registered and extracted CoD. (2) The proportions of deaths in seven categories using two classification systems., Results: A total of 51 patient charts were reviewed. The agreement between the registered and extracted CoD was poor for all causes of death except malignancy. Kappa scores ranged from 0.55 to 1.0 for different causes. PPV were poor for all except malignancy. Comparison of the CoD was highly dependent on the classification method used (e.g., death secondary to infection was 4% and 25% for CORR and HEMO, respectively)., Conclusions: The registered CoD for patients who die while on PD is often inaccurate. Different policies for classifying deaths can have a significant effect on the final reports, which show the proportion of deaths attributed to different diseases. Standardization across registries is required.

We conducted a study to evaluate the effectiveness of muscle-pedicle hyoid bone flaps in the repair and reconstruction of the larynx and trachea in 23 patients who had undergone extended partial laryngectomy. Of this group, 17 patients had undergone surgery to correct laryngotracheal stenosis and 6 to remove laryngeal carcinoma. Intervention resulted in successful decannulation in 20 of the 23 patients (87.0%). Of the 3 patients who did not experience a successful outcome initially, 2 were successfully decannulated following a second intervention; the other patient required a total laryngectomy because of cancer recurrence. In light of our follow-up results, we conclude that hyoid bone appears to be an effective autograft in such cases.