Background Kidney biopsy provides important information for nephrologists, but the risk of complications has not been systematically described. Study Design Meta-analysis of randomized controlled ...trials and prospective or retrospective observational studies. Setting & Population Adults undergoing native kidney biopsy in an inpatient or outpatient setting. Selection Criteria for Studies MEDLINE indexed studies from January 1980 through June 2011; sample size of 50 or more. Intervention Native kidney biopsy with automated biopsy device and real-time ultrasonographic guidance. Outcomes Macroscopic hematuria and erythrocyte transfusion rates and factors associated with these outcomes. Results 34 studies of 9,474 biopsies met inclusion criteria. The rate of macroscopic hematuria was 3.5% (95% CI, 2.2%-5.1%), and erythrocyte transfusion was 0.9% (95% CI, 0.4%-1.5%). Significantly higher rates of transfusion were seen with the following: 14-gauge compared with smaller needles (2.1% vs 0.5%; P = 0.009), studies with mean serum creatinine level ≥2.0 mg/dL (2.1% vs 0.4%; P = 0.02), ≥50% women (1.9% vs 0.6%; P = 0.03), and ≥10% of biopsies for acute kidney injury (1.1% vs 0.04%; P < 0.001). Higher transfusion rates also were observed in studies with a mean age of 40 years or older (1.0% vs 0.2%; P = 0.2) and mean systolic blood pressure ≥130 mm Hg (1.4% vs 0.1%; P = 0.09). Similar relationships were noted for the macroscopic hematuria rate with the same predictors, but none was statistically significant. Limitations Publication bias, few randomized controlled trials, and missing data. Conclusions Native kidney biopsy using automated biopsy devices and real-time ultrasonography is associated with a relatively small risk of macroscopic hematuria and erythrocyte transfusion requirement. Using smaller gauge needles may lower complication rates. Patient selection may affect outcome because studies with higher serum creatinine levels, more women, and higher rates of acute kidney injury had higher complication rates. Future studies should further evaluate risk factors for complications.
Background Targeting higher hemoglobin levels with erythropoiesis-stimulating agents (ESAs) to treat the anemia of chronic kidney disease (CKD) is associated with increased cardiovascular risk. Study ...Design Metaregression analysis examining the association of ESA dose with adverse outcomes independent of target or achieved hemoglobin level. Setting & Population Patients with anemia of CKD irrespective of dialysis status. Selection Criteria for Studies We searched MEDLINE (inception to August 2010) and bibliographies of published meta-analyses and selected randomized controlled trials assessing the efficacy of ESAs for the treatment of anemia in adults with CKD, with a minimum 3-month duration. Two authors independently screened citations and extracted relevant data. Individual study arms were treated as cohorts and constituted the unit of analysis. Predictors ESA dose standardized to a weekly epoetin alfa equivalent, and hemoglobin levels. Outcomes All-cause and cardiovascular mortality, cardiovascular events, kidney disease progression, or transfusion requirement. Results 31 trials (12,956 patients) met the criteria. All-cause mortality was associated with higher (per epoetin alfa–equivalent 10,000-U/wk increment) first-3-month mean ESA dose (incidence rate ratio IRR, 1.42; 95% CI, 1.10-1.83) and higher total-study-period mean ESA dose (IRR, 1.09; 95% CI, 1.02-1.18). First-3-month ESA dose remained significant after adjusting for first-3-month mean hemoglobin level (IRR, 1.48; 95% CI, 1.02-2.14), as did total-study-period mean ESA dose adjusting for target hemoglobin level (IRR, 1.41; 95% CI, 1.08-1.82). Parameter estimates between ESA dose and cardiovascular mortality were similar in magnitude and direction, but not statistically significant. Higher total-study-period mean ESA dose also was associated with increased rate of hypertension, stroke, and thrombotic events, including dialysis vascular access–related thrombotic events. Limitations Use of study-level aggregated data; use of epoetin alfa–equivalent doses; lack of adjustment for confounders. Conclusions In patients with CKD, higher ESA dose might be associated with all-cause mortality and cardiovascular complications independent of hemoglobin level.
We summarize the 2016 update of the 2004 Agency of Healthcare Research and Quality's evidence review of omega-3 fatty acids and cardiovascular disease (CVD). The overall findings for the effects of ...marine oil supplements on intermediate CVD outcomes remain largely unchanged. There is high strength of evidence, based on numerous trials, of no significant effects of marine oils on systolic or diastolic blood pressures, but there are small, yet statistically significant increases in high density lipoprotein and low density lipoprotein cholesterol concentrations. The clinical significance of these small changes, particularly in combination, is unclear. The strongest effect of marine oils is on triglyceride concentrations. Across studies, this effect was dose-dependent and related to studies' mean baseline triglyceride concentration. In observational studies, there is low strength of evidence that increased marine oil intake lowers ischemic stroke risk. Among randomized controlled trials and observational studies, there is evidence of variable strength of no association with increased marine oil intake and lower CVD event risk. Evidence regarding alpha-linolenic acid intake is sparser. There is moderate strength of evidence of no effect on blood pressure or lipoprotein concentrations and low strength of evidence of no association with coronary heart disease, atrial fibrillation and congestive heart failure.
Trials have shown efficacy of rigorous diet and physical activity promotion programs to reduce diabetes incidence and improve glycemic measures in adults at increased risk for type 2 diabetes.
To ...evaluate diet and physical activity promotion programs for persons at increased risk for type 2 diabetes, primarily to reduce diabetes risk and decrease body weight and glycemia.
MEDLINE, the Cochrane Central Register of Controlled Trials, CAB Abstracts, Global Health, and Ovid HealthSTAR from 1991 through 27 February 2015, with no language restriction.
8 researchers screened articles for single-group or comparative studies of combined diet and physical activity promotion programs with at least 2 sessions over at least 3 months in participants at increased risk for type 2 diabetes.
7 researchers extracted data on study design; participant, intervention, and outcome descriptions; and results and assessed study quality.
53 studies (30 of diet and physical activity promotion programs vs. usual care, 13 of more intensive vs. less intensive programs, and 13 of single programs) evaluated 66 programs. Compared with usual care, diet and physical activity promotion programs reduced type 2 diabetes incidence (risk ratio RR, 0.59 95% CI, 0.52 to 0.66) (16 studies), decreased body weight (net change, -2.2% CI, -2.9% to -1.4%) (24 studies) and fasting blood glucose level (net change, -0.12 mmol/L -2.2 mg/dL CI, -0.20 to -0.05 mmol/L {-3.6 to -0.9 mg/dL}) (17 studies), and improved other cardiometabolic risk factors. Evidence for clinical events was limited. More intensive programs were more effective.
Wide variation in diet and physical activity promotion programs limited identification of features most relevant to effectiveness. Evidence on clinical outcomes and in children was sparse.
Combined diet and physical activity promotion programs are effective at decreasing diabetes incidence and improving cardiometabolic risk factors in persons at increased risk. More intensive programs are more effective.
Centers for Disease Control and Prevention Community Preventive Services Task Force.
Clinical guidelines recommend that adults with hypertension self-monitor their blood pressure (BP).
To summarize evidence about the effectiveness of self-measured blood pressure (SMBP) monitoring in ...adults with hypertension.
MEDLINE (inception to 8 February 2013) and Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews (fourth quarter 2012).
52 prospective comparative studies of SMBP monitoring with or without additional support versus usual care or an alternative SMBP monitoring intervention in persons with hypertension.
Data on population, interventions, BP, other outcomes, and study method were extracted. Random-effects model meta-analyses were done.
For SMBP monitoring alone versus usual care (26 comparisons), moderate-strength evidence supports a lower BP with SMBP monitoring at 6 months (summary net difference, -3.9 mm Hg and -2.4 mm Hg for systolic BP and diastolic BP) but not at 12 months. For SMBP monitoring plus additional support versus usual care (25 comparisons), high-strength evidence supports a lower BP with use of SMBP monitoring, ranging from -3.4 to -8.9 mm Hg for systolic BP and from -1.9 to -4.4 mm Hg for diastolic BP, at 12 months in good-quality studies. For SMBP monitoring plus additional support versus SMBP monitoring alone or with less intense additional support (13 comparisons), low-strength evidence fails to support a difference. Across all comparisons, evidence for clinical outcomes is insufficient. For other surrogate or intermediate outcomes, low-strength evidence fails to show differences.
Clinical heterogeneity in protocols for SMBP monitoring, additional support, BP targets, and management; follow-up of 1 year or less in most studies, with sparse clinical outcome data.
Self-measured BP monitoring with or without additional support lowers BP compared with usual care, but the BP effect beyond 12 months and long-term benefits remain uncertain. Additional support enhances the BP-lowering effect.
Agency for Healthcare Research and Quality.
Solid tumor chemotherapy regimens pose a risk for hepatitis B virus (HBV) reactivation, but screening and antiviral prophylaxis remains controversial because of insufficient evidence.
To determine ...the risk for HBV reactivation with and without antiviral prophylaxis and the effectiveness of prophylaxis in adults with solid tumors and chronic or resolved HBV infection.
MEDLINE through 1 July 2015 and Web of Science, Cochrane Central Register of Controlled Trials, TOXNET, and Scopus through 1 March 2015.
26 English-language observational studies and randomized, controlled trials in patients with chronic or resolved HBV receiving chemotherapy for solid tumors.
Study characteristics, quality, and risk of bias were assessed by 1 researcher and verified by another independent researcher.
Random-effects model meta-analyses were used to estimate the risk and odds ratio (OR) of reactivation with versus without antiviral prophylaxis. Reactivation in chronic HBV without prophylaxis ranged from 4% to 68% (median, 25%) with substantial heterogeneity. Prophylaxis reduced the risk for HBV reactivation (OR, 0.12 95% CI, 0.06 to 0.22), HBV-related hepatitis (OR, 0.18 CI, 0.10 to 0.32), and chemotherapy interruption (OR, 0.10 CI, 0.04 to 0.27). In 3 studies of patients with resolved HBV infection, none received HBV prophylaxis and reactivation risk ranged from 0.3% to 9.0%.
Significant heterogeneity in underlying study populations and treatment regimens, incomplete baseline data, possibility of publication bias, and limited study quality. Most studies were observational and from Asia.
In patients with chronic HBV receiving solid tumor chemotherapy, the risk for HBV reactivation is similar to the risk with other types of immunosuppressive therapy. Results support HBV screening and antiviral prophylaxis before initiation of chemotherapy for solid tumors.
National Center for Advancing Translational Sciences and National Institutes of Health.
Patients with resolved hepatitis B virus (HBV) infection who are treated for hematological malignancies remain at risk for HBV reactivation. Because of conflicting studies about whether the antibody ...to hepatitis B surface antigen (anti‐HBs) protects against reactivation in patients with resolved infection (hepatitis B surface antigen negative) receiving chemotherapy for hematological malignancies, we conducted a meta‐analysis to determine if anti‐HBs reduces HBV reactivation risk. We sought English‐language studies through March 1, 2016, in Medline and other sources that examined reactivation in patients with resolved HBV infection receiving chemotherapy for hematologic malignancies. The absolute risks and odds ratio (OR) of reactivation with versus without anti‐HBs were estimated in random‐effects model meta‐analyses. In 20 studies involving 1,672 patients not receiving antiviral prophylaxis, the reactivation risk was 14% (95% confidence interval CI 9.4%‐19%) in 388 patients who had antibodies to hepatitis B core antigen only versus 5.0% (95% CI 3.0%‐7.0%) in 1,284 patients who also had anti‐HBs. Anti‐HBs reduced reactivation risk with a pooled OR of 0.21 (95% CI 0.14‐0.32) versus patients with antibody to hepatitis B core antigen only. Similar results were found when limiting the analysis to rituximab chemotherapy (OR = 0.19, 95% CI 0.11‐0.32) and lymphoma (OR = 0.18, 95% CI 0.11‐0.28). Conclusion: In patients with resolved HBV receiving chemotherapy for hematological malignancies without antiviral prophylaxis, anti‐HBs positivity is associated with a decreased risk of reactivation; HBV screening in this patient population should include the routine use of anti‐HBs, and those who are anti‐HBs‐negative should receive antiviral prophylaxis. Future studies should examine the effect of anti‐HBs serum titers, the potential role for booster vaccinations, and antiviral prophylaxis prior to chemotherapy in this patient population. (Hepatology 2017;66:379–388).
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 ...meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses containing 1973 trials. Outcome measures were classified as "mortality," "other objective," "or subjective," and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity. Intervention effect estimates seemed to be exaggerated in trials with inadequate or unclear (vs. adequate) random-sequence generation (ratio of odds ratios, 0.89 95% credible interval {CrI}, 0.82 to 0.96) and with inadequate or unclear (vs. adequate) allocation concealment (ratio of odds ratios, 0.93 CrI, 0.87 to 0.99). Lack of or unclear double-blinding (vs. double-blinding) was associated with an average of 13% exaggeration of intervention effects (ratio of odds ratios, 0.87 CrI, 0.79 to 0.96), and between-trial heterogeneity was increased for such studies (SD increase in heterogeneity, 0.14 CrI, 0.02 to 0.30). For each characteristic, average bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes, with little evidence of bias in trials with objective and mortality outcomes. This study is limited by incomplete trial reporting, and findings may be confounded by other study design characteristics. Bias associated with study design characteristics may lead to exaggeration of intervention effect estimates and increases in between-trial heterogeneity in trials reporting subjectively assessed outcomes.
The role of vitamin D in people who are at risk for type 2 diabetes remains unclear.
To evaluate whether administration of vitamin D decreases risk for diabetes among people with prediabetes.
PubMed, ...Embase, and ClinicalTrials.gov from database inception through 9 December 2022.
Eligible trials that were specifically designed and conducted to test the effects of oral vitamin D versus placebo on new-onset diabetes in adults with prediabetes.
The primary outcome was time to event for new-onset diabetes. Secondary outcomes were regression to normal glucose regulation and adverse events. Prespecified analyses (both unadjusted and adjusted for key baseline variables) were conducted according to the intention-to-treat principle.
Three randomized trials were included, which tested cholecalciferol, 20 000 IU (500 mcg) weekly; cholecalciferol, 4000 IU (100 mcg) daily; or eldecalcitol, 0.75 mcg daily, versus matching placebos. Trials were at low risk of bias. Vitamin D reduced risk for diabetes by 15% (hazard ratio, 0.85 95% CI, 0.75 to 0.96) in adjusted analyses, with a 3-year absolute risk reduction of 3.3% (CI, 0.6% to 6.0%). The effect of vitamin D did not differ in prespecified subgroups. Among participants assigned to the vitamin D group who maintained an intratrial mean serum 25-hydroxyvitamin D level of at least 125 nmol/L (≥50 ng/mL) compared with 50 to 74 nmol/L (20 to 29 ng/mL) during follow-up, cholecalciferol reduced risk for diabetes by 76% (hazard ratio, 0.24 CI, 0.16 to 0.36), with a 3-year absolute risk reduction of 18.1% (CI, 11.7% to 24.6%). Vitamin D increased the likelihood of regression to normal glucose regulation by 30% (rate ratio, 1.30 CI, 1.16 to 1.46). There was no evidence of difference in the rate ratios for adverse events (kidney stones: 1.17 CI, 0.69 to 1.99; hypercalcemia: 2.34 CI, 0.83 to 6.66; hypercalciuria: 1.65 CI, 0.83 to 3.28; death: 0.85 CI, 0.31 to 2.36).
Studies of people with prediabetes do not apply to the general population. Trials may not have been powered for safety outcomes.
In adults with prediabetes, vitamin D was effective in decreasing risk for diabetes.
None. (PROSPERO: CRD42020163522).
Background Some studies have suggested that early institution of renal replacement therapy (RRT) might be associated with improved outcomes in patients with acute renal failure (ARF). Study Design A ...systematic review and meta-analysis of randomized controlled trials and cohort comparative studies to assess the effect of early RRT on mortality in patients with ARF. Setting & Population Hospitalized adult patients with ARF. Selection Criteria for Studies We searched several databases for studies that compared the effect of “early” and “late” RRT initiation on mortality in patients with ARF. We included studies of various designs. Intervention Early RRT as defined in the individual studies. Outcomes The primary outcome measure was the effect of early RRT on mortality stratified by study design. The pooled risk ratio (RR) for mortality was compiled using a random-effects model. Heterogeneity was evaluated by means of subgroup analysis and meta-regression. Results We identified 23 studies (5 randomized or quasi-randomized controlled trials, 1 prospective and 16 retrospective comparative cohort studies, and 1 single-arm study with a historic control group). By using meta-analysis of randomized trials, early RRT was associated with a nonsignificant 36% mortality risk reduction (RR, 0.64; 95% confidence interval, 0.40 to 1.05; P = 0.08). Conversely, in cohort studies, early RRT was associated with a statistically significant 28% mortality risk reduction (RR, 0.72; 95% confidence interval, 0.64 to 0.82; P < 0.001). The overall test for heterogeneity among cohort studies was significant ( P = 0.005). Meta-regression yielded no significant associations; however, early dialysis therapy was associated more strongly with lower mortality in smaller studies (n < 100) by means of subgroup analysis. Limitations Paucity of randomized controlled trials, use of variable definitions of early RRT, and publication bias preclude definitive conclusions. Conclusion This hypothesis-generating meta-analysis suggests that early initiation of RRT in patients with ARF might be associated with improved survival, calling for an adequately powered randomized controlled trial to address this question.
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