Background Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant ...to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis. Study Design In a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents’ scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated. Setting & Participants 1,181 participants (202 17% patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3. Outcomes & Measurements Outcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score ≥ 8, mean score ≥ 7.5, proportion rating the outcome as critically important ≥ 75%, and median score in the forced ranking question < 10. Results Patients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively). Limitations The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection. Conclusions Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions.
The risk of major bleeding after percutaneous native kidney biopsy is usually considered low but remains poorly predictable. The aim of the study was to assess the risk of major bleeding and to build ...a preprocedure bleeding risk score.
Our study was a retrospective cohort study in all 52,138 patients who had a percutaneous native kidney biopsy in France in the 2010-2018 period. Measurements included major bleeding (
, blood transfusions, hemorrhage/hematoma, angiographic intervention, or nephrectomy) at day 8 after biopsy and risk of death at day 30. Exposures and outcomes were defined by diagnosis codes.
Major bleeding occurred in 2765 of 52,138 (5%) patients (blood transfusions: 5%; angiographic intervention: 0.4%; and nephrectomy: 0.1%). Nineteen diagnoses were associated with major bleeding. A bleeding risk score was calculated (Charlson index 2-4: +1; 5 and 6: +2; >6: +3; frailty index 1.5-4.4: +1; 4.5-9.5: +2; >9.5: +3; women: +1; dyslipidemia: -1; obesity: -1; anemia: +8; thrombocytopenia: +2; cancer: +2; abnormal kidney function: +4; glomerular disease: -1; vascular kidney disease: -1; diabetic kidney disease: -1; autoimmune disease: +2; vasculitis: +5; hematologic disease: +2; thrombotic microangiopathy: +4; amyloidosis: -2; other kidney diagnosis: -1) + a constant of 5. The risk of bleeding went from 0.4% (lowest score group =0-4 points) to 33% (highest score group ≥35 points). Major bleeding was an independent risk of death (500 of 52,138 deaths: bleeding: 81 of 2765 3%; no bleeding: 419 of 49,373 0.9%; odds ratio, 1.95; 95% confidence interval, 1.50 to 2.54;
<0.001).
The risk of major bleeding after percutaneous native kidney biopsy may be higher than generally thought and is associated with a twofold higher risk of death. It varies widely but can be estimated with a score useful for shared decision making and procedure choice.
Many drugs are responsible, through different mechanisms, for peripheral oedema. Severity is highly variable, ranging from slight oedema of the lower limbs to anasarca pictures as in the capillary ...leak syndrome. Although most often noninflammatory and bilateral, some drugs are associated with peripheral oedema that is readily erythematous (eg, pemetrexed) or unilateral (eg, sirolimus). Thus, drug‐induced peripheral oedema is underrecognized and misdiagnosed, frequently leading to a prescribing cascade. Four main mechanisms are involved, namely precapillary arteriolar vasodilation (vasodilatory oedema), sodium/water retention (renal oedema), lymphatic insufficiency (lymphedema) and increased capillary permeability (permeability oedema). The underlying mechanism has significant impact on treatment efficacy. The purpose of this review is to provide a comprehensive analysis of the main causative drugs by illustrating each pathophysiological mechanism and their management through an example of a drug.
Abstract Objectives The Core Outcome Measures in Effectiveness Trial initiative aims at developing core outcome set (COS) for research. Consensus on a COS for renoprotection research is lacking. We ...performed a systematic review (SR) of SRs of renoprotection to identify outcomes used in renoprotection research and to assess how frequently these outcomes could be meta-analyzed in the SRs. Study Design and Setting We searched for SRs with meta-analyses of renoprotection treatments in the Database of Abstracts of Reviews of Effects and in MEDLINE and collected outcomes that were meta-analyzed. For each outcome and SR, we assessed the proportion of trials/patients that could be meta-analyzed. Results We retrieved 66 SRs. A total of 609 outcomes were extracted for 20 distinct renoprotection outcomes. The median (interquartile range) proportion of SRs in which these outcomes had been meta-analyzed was 8% (2%, 27%) (range 2–50%). The proportion of trials that had been aggregated was >75% for only 36% of the outcomes. Conclusion The outcomes meta-analyzed in renoprotection trials are heterogeneous, with a low proportion of trials or patients pooled for each outcome and each SR. A COS is needed in renoprotection research to limit this waste of research. The outcomes identified in the present work could be a basis for this COS.
Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient ...centered. The Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes.
Cardiorenal syndromes (CRSs) are reputed to result in worse prognosis than isolated heart failure (HF) and chronic kidney disease (CKD). Whether it is true for all major outcomes over the long-term ...regardless of CRS chronology (simultaneous, cardiorenal and renocardiac CRS) is unknown.
The 5-year adjusted risk of major outcomes was assessed in this nationwide retrospective cohort study in all 385 687 with either CKD or HF (out of 5 123 193 patients who were admitted in a French hospital in 2012).
Overall, 84.0% patients had HF and 8.9% had CKD (they had similar age, sex ratio, diabetes and hypertension prevalence), while 7.1% had CRS (cardiorenal: 44.6%, renocardiac: 14.5%, simultaneous CRS: 40.8%).The incidence of major outcomes was 57.3%, 53.0%, 79.2% for death; 18.8%, 10.9%, 27.5% for cardiovascular death; 52.6%, 34.7%, 64.3% for HF; 6.2%, 5.5%, 5.6% for myocardial infarction (MI); 6.1%, 5.8%, 5.3% for ischaemic stroke; and 23.1%, 4.8%, 16.1% for end-stage kidney disease (ESKD) for isolated CKD, isolated HF and CRS, respectively.As compared with isolated CKD or HF, the risk of death, cardiovascular death and HF was markedly increased in CRS, the worse phenotype being cardiorenal CRS, while the increased risk of MI and ischaemic stroke associated with CRS subtypes was statistically but not clinically significant. As compared with isolated CKD, the risk of ESKD was similar for cardiorenal CRS only and marginally increased for renocardiac and simultaneous CRS. We could not find a synergy between HF and CKD on major clinical outcomes in the whole population (n = 5 123 193 patients).
The additional impact of CRS versus isolated HF or CKD on long-term kidney and cardiovascular risk is highly heterogenous, depending of the event considered and CRS chronology. No synergy between HF and CKD could be demonstrated.
Comorbidity scores to predict mortality are very useful to facilitate decision-making for personalized patient management. This study aim was to assess the contribution of medico-administrative data ...in addition to French Renal Epidemiology and Information Network (REIN) data to the development of a risk score to predict the 1-year all-cause mortality in patients with End Stage Renal Disease (ESRD), and to compare it with previous scores. Data from a derivation sample (n = 6336 patients who started dialysis in 2015 in France) obtained by linking the REIN and the French National Health Insurance Information System databases were analyzed with multivariate Cox models to select risk factors to establish the score. A randomly chosen validation sample (n = 2716 patients who started dialysis in 2015) was used to validate the score and to compare it with the comorbidity indexes developed by Wright and Charlson. The ability to predict one-year mortality of the score constructed using REIN data linked to the medico-administrative database was not higher than that of the score constructed using only REIN data (i.e., Rennes score). The Rennes score included five comorbidities, albumin, and age. This score (AUC = 0.794, 95%CI: 0.768-0.821) outperformed both the Wright (AUC = 0.631, 95%CI: 0.621-0.639; p < 0.001) and Charlson (AUC = 0.703, 95%CI: 0.689-0.716; p < 0.001) indexes. Data from the REIN registry alone, collected at dialysis start, are sufficient to develop a risk score that can predict the one-year mortality in patients with ESRD. This simple score might help identifying high risk patients and proposing the most adapted care.
Posterior reversible encephalopathy syndrome (PRES) is a clinicoradiological entity characterized by a typical brain edema. Its pathogenesis is still debated through hypoperfusion and hyperperfusion ...theories, which have many limitations. As PRES occurs almost exclusively in clinical situations with arginine vasopressin (AVP) hypersecretion, such as eclampsia and sepsis, we hypothesize that AVP plays a central pathophysiologic role. In this review, we discuss the genesis of PRES and its symptoms through this novel approach. We theorize that AVP axis stimulation precipitates PRES development through an increase in AVP secretion or AVP receptor density. Activation of vasopressin V
1
a
receptors leads to cerebral vasoconstriction, causing endothelial dysfunction and cerebral ischemia. This promotes cytotoxic edema through hydromineral transglial flux dysfunction and may increase endothelial permeability, leading to subsequent vasogenic brain edema. If our hypothesis is confirmed, it opens new perspectives for better patient monitoring and therapies targeting the AVP axis in PRES.
Medicolegal physicians are increasingly called upon to aid in determining the administrative age group affiliation of refugees with questionable unaccompanied minor claims. According to guidelines ...for forensic age assessment, age differentiation along the 18-year-old cut-off relies on clavicular ossification. The thin-slice computed tomography scan (TSCTs) of the medial clavicular epiphysis (MCE) is one of the methods contributing to this assessment, though it is not yet universally accepted. The aim of this systematic review was to identify scientific papers where age was assessed using TSCTs of the MCE and to observe whether this examination was reproducible and reliable in estimating a person’s age relative to the 18-year-old threshold. A search algorithm was applied to several databases to identify articles in accordance with the PRISMA (Preferred Reporting Items for Systematic-Reviews and Meta-Analyses) statement. One boxplot per article was constructed, separating by stage of maturation and sex. The 13 articles selected represented a sample of 5605 individuals (3396 males, 2209 females) aged 10 to 35 years. All individuals classified as stages 4 and 5 were aged 18 years or older. The same result was obtained concerning stage 3c, except in one article. The results thus appear reliable and reproducible, in particular, with respect to the 18-year-old threshold; medicolegal physicians should be able to estimate that all individuals in stages 4 and 5 are at least 18 years old. Additional studies applied to several other populations in the world should complement the selected studies.
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