The gut microbiome is composed of a diverse population of bacteria that have beneficial and adverse effects on human health. The microbiome has recently gained attention and is increasingly noted to play a significant role in health and a number of disease states. Increasing urea concentration during chronic kidney disease (CKD) leads to alterations in the intestinal flora that can increase production of gut-derived toxins and alter the intestinal epithelial barrier. These changes can lead to an acceleration of the process of kidney injury. A number of strategies have been proposed to interrupt this pathway of injury in CKD. The purpose of this review is to summarize the role of the gut microbiome in CKD, tools used to study this microbial population, and attempts to alter its composition for therapeutic purposes.
Light chain deposition disease (LCDD) is characterized by monotypic immunoglobulin depositions which will eventually lead to loss of organ function if left untreated. While the kidney is almost always affected, the presence and degree of LCDD in other organs vary. Ten to thirty percent of LCDD patients have underlying Multiple Myeloma (MM), yet outcome and prognostic markers in this particular patient group are still lacking. Here, we analyzed 69 patients with MM and biopsy proven LCDD and report on renal and extra‐renal involvement and its impact on prognosis as well as renal response depending on hematologic response. Coexisting light chain diseases such as AL amyloid and cast nephropathy were found in 30% of patients; those with LCDD and concurrent amyloid tended to have shorter survival. Cardiac involvement by LCDD was seen in one‐third of our patients and was associated with shorter overall survival; such patients also had a significantly higher risk of treatment‐related mortality (TRM) after stem cell transplant (SCT) compared to LCDD patients without cardiac involvement. This study highlights that MM patients with LCDD present with different clinical features compared to previously reported LCDD cohorts. Rapid initiation of treatment is necessary to prevent progressive renal disease and worse outcome. Coexisting light chain diseases and cardiac involvement are more common than previously reported and confer worse clinical outcome, emphasizing the need for careful patient careful patient evaluation and treatment selection.
Objective: To assess the association of industry funding with the characteristics, outcome, and reported quality of randomized controlled trials (RCTs) of drug therapy for rheumatoid arthritis (RA).Methods: The Medline and Cochrane Central Register of Controlled Trials databases were searched to identify original RA drug therapy RCTs published in 2002–2003 and 2006–2007. Two reviewers independently assessed each RCT for the funding source, characteristics, outcome (positive [statistically significant result favoring experimental drug for the primary outcome] or not positive), and reporting of methodologic measures whose inadequate performance may have biased the assessment of treatment effect. RCTs that were registered at ClinicalTrials.gov and completed during the study years were assessed for publication bias.Results: Of the 103 eligible RCTs identified, 58 (56.3%) were funded by industry, 19 (18.4%) were funded by nonprofit sources, 6 (5.8%) had mixed funding, and funding for 20 (19.4%) was not specified. Industry‐funded RCTs had significantly more study centers and subjects, while nonprofit agency–funded RCTs had longer duration and were more likely to study different treatment strategies. Outcome could be assessed for 86 (83.5%) of the 103 RCTs studied. The funding source was not associated with a higher likelihood of positive outcomes favoring the sponsored experimental drug (75.5% of industry‐funded RCTs had a positive outcome, compared with 68.8% of non‐industry–funded RCTs, 40% of RCTs with mixed funding, and 81.2% of RCTs for which funding was not specified). Industry‐funded RCTs showed a trend toward a higher likelihood of nonpublication (P = 0.093). Industry‐funded RCTs were more frequently associated with double‐blinding, an adequate description of participant flow, and performance of an intent‐to‐treat analysis.Conclusion: Industry funding was not associated with a higher likelihood of positive outcomes of published RCTs of drug therapy for RA, and industry‐funded RCTs performed significantly better than non–industry‐funded RCTs in terms of reporting the use of some key methodologic quality measures.
1 September 2017 in Peritoneal Dialysis International: Journal of the International Society for Peritoneal Dialysis
Background: Improvement in the rates of home dialysis has been a desirable but difficult-to-achieve target for United States nephrology. Provision of comprehensive predialysis education (CPE) in institutes with established home dialysis programs has been shown to facilitate a higher home dialysis choice amongst chronic kidney disease (CKD) patients. Unfortunately, limited data have shown the efficacy of such programs in the United States or in institutes with small home dialysis (HoD) programs. Methods: We report the retrospective findings examining the efficacy of a CPE program in the early period after its establishment, with reference to its impact on the choice and growth of a small HoD program. Results: Over the initial 22 months since its inception, 108 patients were enrolled in the CPE clinic. Seventy percent of patients receiving CPE chose HoD, of which 55% chose peritoneal dialysis (PD) and 15% chose home hemodialysis (HHD). Rates of HoD choice were similar across the spectrum of socio-economic variables. Of just over half (54.6%) of those choosing to return for more than 1 session, 25.3%, changed their modality preference after the first education session, and nearly all reached a final modality selection by the end of the third visit. Initiation of the CPE program resulted in a 216% growth in HoD census over the same period and resulted in near doubling of HoD prevalence to 38% of all dialysis patients. Conclusions: Comprehensive patient education improves the choice and prevalence of HoD therapies. We further find that 3 sessions of CPE may provide needed resources for the large majority of subjects for adequate decision-making.
Background: Chronic kidney disease (CKD) incidence is increasing and associated mortality and morbidity are high. Educating patients is effective in delaying progression and establishing optimal renal replacement therapy (RRT). Tele-education/telemedicine (TM) can be an effective tool to provide such education, but there are no available data quantifying its effectiveness. We attempted to establish such evidence correlating the effect of education in patient choices and with the start of actual RRT. We present results from a 3-year pilot study evaluating the effectiveness of comprehensive predialysis education (CPE) through TM for CKD patients compared with a standard care group [face to face (FTF)]. The patient’s ability to choose RRT was the primary endpoint. Methods: This was a randomized controlled study providing CPE over three classes at nine sites (one FTF and eight TM). Three assessment tools were utilized to compare groups: CKD knowledge, literacy and quality of life. Results: A total of 47.1% of FTF and 52.2% of TM patients reported not having enough information to choose a modality. This decreased by the third visit (FTF 7.4%, TM 13.2%). Home modality choices more than doubled in both groups (FTF 25.8–67.7%, TM 22.2–50.1%). In patients that completed one visit and needed to start RRT, 47% started on a home modality or received a pre-emptive transplant (home hemodialysis 6%, peritoneal dialysis 38%, transplant 3%). Conclusions: Results show almost 90% (TM 87%, FTF 95%) of the attendees could choose a modality after education. Home modality choices doubled. Patients were able to make an informed choice regardless of the modality of education.
Objective: To examine characteristics associated with the publication and timeliness of publication of randomized controlled trials (RCTs) of treatment of rheumatoid arthritis (RA).Methods: RA RCTs (phases II–IV) registered at ClinicalTrials.gov and completed by December 31, 2009 were identified. A standardized strategy was used to determine publication status and outcome assessment. The association of RCT characteristics recorded at ClinicalTrials.gov and study outcome with publication and time to publication were assessed.Results: A search conducted at least 30 months after trial completion revealed that among 143 eligible RCTs, 95 (64.4%) were published. The 48 unpublished RCTs had enrolled >10,000 patients. Efficacy outcomes could be ascertained for 127 of the RCTs. RCT publication was associated with positive outcome, with an adjusted odds ratio [OR] of 4.3 (95% confidence interval [95% CI] 1.8–10.2) (P = 0.001), and marginally with RCT registration before completion (adjusted OR 0.4 [95% CI 0.1–1.0], P = 0.06). The estimated median time to publication was 38 months. Positive outcome was associated with earlier publication (adjusted hazard ratio 1.9 [95% CI 1.2–2.9], P = 0.006). RCTs completed in 2006–2007 or 2008–2009 were likely to be published sooner than RCTs completed in or before 2005. Sensitivity analyses to assess the impact of 16 RCTs with unknown outcome did not alter these findings, except in the highly implausible scenario of all such trials being positive.Conclusion: Positive study outcome was associated with publication and timeliness of publication despite registration in a publicly available registry. A substantial minority of RA RCTs remained unpublished. Efforts to improve transparency in reporting of clinical trials need to continue.