Background Optimal hydration measures to prevent contrast-induced nephropathy are controversial. Study Design We conducted a systematic review and meta-analysis using the MEDLINE database (1966 to ...January 2008), EMBASE (January 2008), and abstracts from conference proceedings. Setting & Population Adult patients undergoing contrast procedures. Selection Criteria for Studies Randomized controlled trials comparing intravenous hydration with sodium bicarbonate with hydration with intravenous normal saline for prevention of contrast-induced nephropathy. Intervention Hydration with intravenous sodium bicarbonate with or without N -acetylcysteine versus hydration with normal saline with or without N -acetylcysteine. Outcomes Contrast-induced nephropathy, need for renal replacement therapy, and worsening of heart failure. Results Twelve trials (1,854 participants) were included. Sodium bicarbonate significantly decreased the risk of contrast-induced nephropathy (12 trials, 1,652 patients; odds ratio OR, 0.46; 95% confidence interval CI, 0.26 to 0.82; I2 = 55.9%) without a significant difference in need for renal replacement therapy (9 trials, 1,215 patients; OR, 0.50; 95% CI, 0.16 to 1.53; I2 = 0%), in-hospital mortality (11 trials, 1,640 patients; OR, 0.51; 95% CI, 0.15 to 1.69), or congestive heart failure compared with controls. Similar results were seen for the risk of contrast-induced nephropathy when sodium bicarbonate was compared with normal saline alone (OR, 0.39; 95% CI, 0.20 to 0.77), but not when sodium bicarbonate/ N -acetylcysteine combination was compared with N -acetylcysteine/normal saline combination (OR, 0.68; 95% CI, 0.34 to 1.37). A subgroup analysis limited to published trials showed similar results (OR, 0.26; 95% CI, 0.10 to 0.64; I2 = 63.3%), whereas unpublished studies showed a nonsignificant decrease (OR, 0.85; 95% CI, 0.46 to 1.57; I2 = 25.9%) in risk of contrast-induced nephropathy. Limitation Publication bias and heterogeneity. Conclusion Hydration with sodium bicarbonate decreases the incidence of contrast-induced nephropathy in comparison to hydration with normal saline without a significant difference in need for renal replacement therapy and in-hospital mortality. Larger studies analyzing patient-centered outcomes are needed.
Rosiglitazone and pioglitazone may increase the incidence of fractures. We aimed to determine systematically the risk of fractures associated with thiazolidinedione therapy and to evaluate the effect ...of the therapy on bone density.
We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), other trial registries and product information sheets through June 2008. We selected long-term (> or = 1 year) randomized controlled trials involving patients with type 2 diabetes and controlled observational studies that described the risk of fractures or changes in bone density with thiazolidinediones. We calculated pooled odds ratios (ORs) for fractures and the weighted mean difference in bone density.
We analyzed data from 10 randomized controlled trials involving 13 715 participants and from 2 observational studies involving 31 679 participants. Rosiglitazone and pioglitazone were associated with a significantly increased risk of fractures overall in the 10 randomized controlled trials (OR 1.45, 95% confidence interval CI 1.18-1.79; p < 0.001). Five randomized controlled trials showed a significantly increased risk of fractures among women (OR 2.23, 95% CI 1.65-3.01; p < 0.001) but not among men (OR 1.00, 95% CI 0.73-1.39; p = 0.98). The 2 observational studies demonstrated an increased risk of fractures associated with rosiglitazone and pioglitazone. Bone mineral density in women exposed to thiazolidinediones was significantly reduced at the lumbar spine (weighted mean difference -1.11%, 95% CI -2.08% to -0.14%; p = 0.02) and hip (weighted mean difference -1.24%, 95%CI -2.34% to -0.67%; p < 0.001) in 2 randomized controlled trials.
Long-term thiazolidinedione use doubles the risk of fractures among women with type 2 diabetes, without a significant increase in risk of fractures among men with type 2 diabetes.
Background Colorectal cancer (CRC) screening reduces mortality yet remains underutilized. Low health literacy may contribute to this underutilization by interfering with patients' ability to ...understand and receive preventive health services. Purpose To determine if a web-based multimedia CRC screening patient decision aid, developed for a mixed-literacy audience, could increase CRC screening. Design RCT. Patients aged 50–74 years and overdue for CRC screening were randomized to the web-based decision aid or a control program seen immediately before a scheduled primary care appointment. Setting/participants A large community-based, university-affiliated internal medicine practice serving a socioeconomically disadvantaged population. Main outcome measures Patients completed surveys to determine their ability to state a screening test preference and their readiness to receive screening. Charts were abstracted by masked observers to determine if screening tests were ordered and completed. Results Between November 2007 and September 2008, a total of 264 patients enrolled in the study. Data collection was completed in 2009, and data analysis was completed in 2010. A majority of participants (mean age=57.8 years) were female (67%), African-American (74%), had annual household incomes of <$20,000 (76%), and had limited health literacy (56%). When compared to control participants, more decision-aid participants had a CRC screening preference (84% vs 55%, p <0.0001) and an increase in readiness to receive screening (52% vs 20%, p =0.0001). More decision-aid participants had CRC screening tests ordered (30% vs 21%) and completed (19% vs 14%), but no statistically significant differences were seen (AOR=1.6, 95% CI=0.97, 2.8, and AOR=1.7, 95% CI=0.88, 3.2, respectively). Similar results were found across literacy levels. Conclusions The web-based decision aid increased patients' ability to form a test preference and their intent to receive screening, regardless of literacy level. Further study should examine ways the decision aid can be combined with additional system changes to increase CRC screening. Trial registration NCT00558233
Abstract Objectives To describe challenges and make recommendations for researchers in how they select evidence to quantitatively assess a prescription drug’s benefits and harms. Study Design and ...Setting These challenges and recommendations are based on our recent experience conducting a benefit-harm assessment for the prescription drug roflumilast. We considered the selection of evidence to quantify (1) the drug’s treatment effects in patients, (2) the patient population’s baseline risks for beneficial and harmful outcomes without treatment, and (3) the patient population’s preferences for these beneficial effects and harms. These are fundamental steps for most benefit-harm assessment methods. Results We identify critical issues in selecting evidence for each of these steps. We justify in particular the need to incorporate (1) clinical trials for the drug’s specific treatment effect; (2) observational studies with the most valid, precise, and applicable effect estimates for the baseline risk; and (3) flexible weighting approaches for balancing the drug benefits and harms. Conclusion We identify challenges and make recommendations for selecting evidence at the critical steps in a prescription drug’s benefit-harm assessment. Our findings should assist other researchers conducting these assessments for prescription drugs, which could help regulators, medical professionals, and patients make better decisions about prescription drug use.
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