Nationwide cohort study of independent risk factors for acute respiratory distress syndrome after trauma.

BACKGROUND: The primary objective of this study was to evaluate the effect of specific direct and indirect factors that accounted, in trauma patients, for the development of acute respiratory distress syndrome (ARDS) and mortality in patients with ARDS. METHODS: We performed a retrospective cohort study of patients from the National Trauma Data Bank. Multilevel mixed-effects logistic regression was used with the development of ARDS as the primary and mortality in patients with ARDS as the secondary outcome measures. We compared trauma patients with versus without thoracic (direct) and extrathoracic (indirect) risk factors, using patient demographics, physiologic, and anatomic injury severity as covariates. Subset analysis was performed for patients with trauma-induced lung contusion (TILC) and for patients with minor (Injury Severity Score [ISS] ≤15) injury. RESULTS: A total of 2 998 964 patients were studied, of whom 28 597 developed ARDS. From 2011 to 2014, the incidence of ARDS decreased; however, mortality in patients with ARDS has increased. Predictors of ARDS included direct thoracic injury (TILC, multiple rib fractures, and flail chest), as well as indirect factors (increased age, male gender, higher ISS, lower Glasgow Coma Scale motor component score, history of cardiopulmonary or hematologic disease, and history of alcoholism or obesity). Patients with ARDS secondary to direct thoracic injury had a lower risk of mortality compared with patients with ARDS due to other mechanisms. DISCUSSION: Despite the decreasing incidence of trauma-induced ARDS, mortality in patients with ARDS has increased. Direct thoracic injury was the strongest predictor of ARDS. Knowing specific contributors to trauma-induced ARDS could help identify at-risk patients early in their hospitalization and mitigate the progression to ARDS and thereby mortality. LEVEL OF EVIDENCE: Prognostic study, level III.

Fluctuations in airway bacterial communities associated with clinical states and disease stages in cystic fibrosis.

Bacteria that infect the airways of persons with cystic fibrosis (CF) include a group of well-described opportunistic pathogens as well as numerous, mainly obligate or facultative anaerobic species typically not reported by standard sputum culture. We sequenced the V3-V5 hypervariable region of the bacterial 16S rRNA gene in DNA derived from 631 sputum specimens collected from 111 CF patients over 10 years. We describe fluctuations in the relative abundances of typical CF pathogens, as well as anaerobic species, in relation to changes in patients' clinical state and lung disease stage. Both bacterial community diversity and the relative abundance of anaerobes increased during exacerbation of symptoms (prior to antibiotic treatment), although this trend was not observed uniformly across disease stages. Community diversity and the relative abundance of anaerobic species decreased during antibiotic treatment. These results support current hypotheses regarding the role of anaerobes in CF pulmonary exacerbations and lung disease progression.

Normalization of the microbiota in patients after treatment for colonic lesions.

BACKGROUND: Colorectal cancer is a worldwide health problem. Despite growing evidence that members of the gut microbiota can drive tumorigenesis, little is known about what happens to it after treatment for an adenoma or carcinoma. This study tested the hypothesis that treatment for adenoma or carcinoma alters the abundance of bacterial populations associated with disease to those associated with a normal colon. We tested this hypothesis by sequencing the 16S rRNA genes in the feces of 67 individuals before and after treatment for adenoma (N = 22), advanced adenoma (N = 19), and carcinoma (N = 26). RESULTS: There were small changes to the bacterial community associated with adenoma or advanced adenoma and large changes associated with carcinoma. The communities from patients with carcinomas changed significantly more than those with adenoma following treatment (P value < 0.001). Although treatment was associated with intrapersonal changes, the change in the abundance of individual OTUs in response to treatment was not consistent within diagnosis groups (P value > 0.05). Because the distribution of OTUs across patients and diagnosis groups was irregular, we used the random forest machine learning algorithm to identify groups of OTUs that could be used to classify pre and post-treatment samples for each of the diagnosis groups. Although the adenoma and carcinoma models could reliably differentiate between the pre- and post-treatment samples (P value < 0.001), the advanced-adenoma model could not (P value = 0.61). Furthermore, there was little overlap between the OTUs that were indicative of each treatment. To determine whether individuals who underwent treatment were more likely to have OTUs associated with normal colons we used a larger cohort that contained individuals with normal colons and those with adenomas, advanced adenomas, and carcinomas. We again built random forest models and measured the change in the positive probability of having one of the three diagnoses to assess whether the post-treatment samples received the same classification as the pre-treatment samples. Samples from patients who had carcinomas changed toward a microbial milieu that resembles the normal colon after treatment (P value < 0.001). Finally, we were unable to detect any significant differences in the microbiota of individuals treated with surgery alone and those treated with chemotherapy or chemotherapy and radiation (P value > 0.05). CONCLUSIONS: By better understanding the response of the microbiota to treatment for adenomas and carcinomas, it is likely that biomarkers will eventually be validated that can be used to quantify the risk of recurrence and the likelihood of survival. Although it was difficult to identify significant differences between pre- and post-treatment samples from patients with adenoma and advanced adenoma, this was not the case for carcinomas. Not only were there large changes in pre- versus post-treatment samples for those with carcinoma, but also these changes were toward a more normal microbiota.

Longitudinal Study of Transfusion Utilization in Hospitalized Veterans.

OBJECTIVE: Although transfusion guidelines have changed considerably over the past two decades, the adoption of patient blood management programs has not been fully realized across hospitals in the United States. PATIENTS AND METHODS: We evaluated trends in red blood cell (RBC), platelet and plasma transfusion at three Veterans Health Administration (VHA) hospitals from 2000 through 2010. RESULTS: There were 176,521 hospitalizations in 69,621 patients; of these, 13.6% of hospitalizations involved transfusion of blood products (12.7% RBCs, 1.4% platelets, 3.0% plasma). Transfusion occurred in 25.2% of surgical and 5.3% of medical hospitalizations. Transfusion use peaked in 2002 for surgical hospitalizations and declined afterwards (p<0.001). There was no significant change in transfusion use over time (p=0.126) for medical hospitalizations. In hospitalizations that involved transfusions, there was a 20.3% reduction in the proportion of hospitalizations in which ≥3 units of RBCs were given (from 51.7% to 41.1%; p<0.001) and a 73.6% increase when one RBC unit was given (from 8.0% to 13.8%; p<0.001) from 2000-2010. Of the hospitalizations with RBC transfusion, 9.6% involved the use of one unit over the entire study period. The most common principal diagnoses for medical patients receiving transfusion were anemia, malignancy, heart failure, pneumonia and renal failure. Over time, transfusion utilization increased in patients who were admitted for infection (p=0.009). CONCLUSION: Blood transfusions in three VHA hospitals have decreased over time for surgical patients but remained the same for medical patients. Further study examining appropriateness of blood products in medical patients appears necessary.

Prediction of Transfusions After Isolated Coronary Artery Bypass Grafting Surgical Procedures.

BACKGROUND: Although blood transfusions are common and have been associated with adverse sequelae after cardiac surgical procedures, few contemporaneous models exist to support clinical decision making. This study developed a preoperative clinical decision support tool to predict perioperative red blood cell transfusions in the setting of isolated coronary artery bypass grafting. METHODS: We performed a multicenter, observational study of 20,377 patients undergoing isolated coronary artery bypass grafting among patients at 39 hospitals participating in the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative's PERFusion measures and outcomes (PERForm) registry between 2011 and 2015. Candidates' preoperative risk factors were identified based on previous work and clinical input. The study population was randomly divided into a 70% development sample and a 30% validation sample. A generalized linear mixed-effect model was developed to predict perioperative red blood cell transfusion. The model's performance was assessed for calibration and discrimination. Sensitivity analysis was performed to assess the robustness of the model in different clinical subgroups. RESULTS: Transfusions occurred in 36.8% of patients. The final regression model included 16 preoperative variables. The correlation between the observed and expected transfusions was 1.0. The risk prediction model discriminated well (receiver operator characteristic [ROC]development, 0.81; ROCvalidation, 0.82) and had satisfactory calibration (correlation between observed and expected rates was r = 1.00). The model performance was confirmed across medical centers and clinical subgroups. CONCLUSIONS: Our risk prediction model uses 16 readily obtainable preoperative variables. This model, which provides a patient-specific estimate of the need for transfusion, offers clinicians a guide for decision making and evaluating the effectiveness of blood management strategies.

Alpha blockers for treatment of ureteric stones: systematic review and meta-analysis.

OBJECTIVE:  To investigate the efficacy and safety of alpha blockers in the treatment of patients with ureteric stones. DESIGN:  Systematic review and meta-analysis. DATA SOURCES:  Cochrane Central Register of Controlled Trials, Web of Science, Embase, LILACS, and Medline databases and scientific meeting abstracts to July 2016. REVIEW METHODS:  Randomized controlled trials of alpha blockers compared with placebo or control for treatment of ureteric stones were eligible. : Two team members independently extracted data from each included study. The primary outcome was the proportion of patients who passed their stone. Secondary outcomes were the time to passage; the number of pain episodes; and the proportions of patients who underwent surgery, required admission to hospital, and experienced an adverse event. Pooled risk ratios and 95% confidence intervals were calculated for the primary outcome with profile likelihood random effects models. Cochrane Collaboration's tool for assessing risk of bias and the GRADE approach were used to evaluate the quality of evidence and summarize conclusions. RESULTS:  55 randomized controlled trials were included. There was moderate quality evidence that alpha blockers facilitate passage of ureteric stones (risk ratio 1.49, 95% confidence interval 1.39 to 1.61). Based on a priori subgroup analysis, there seemed to be no benefit to treatment with alpha blocker among patients with smaller ureteric stones (1.19, 1.00 to 1.48). Patients with larger stones treated with an alpha blocker, however, had a 57% higher risk of stone passage compared with controls (1.57, 1.17 to 2.27). The effect of alpha blockers was independent of stone location (1.48 (1.05 to 2.10) for upper or middle stones; 1.49 (1.38 to 1.63) for lower stones). Compared with controls, patients who received alpha blockers had significantly shorter times to stone passage (mean difference -3.79 days, -4.45 to -3.14; moderate quality evidence), fewer episodes of pain (-0.74 episodes, -1.28 to -0.21; low quality evidence), lower risks of surgical intervention (risk ratio 0.44, 0.37 to 0.52; moderate quality evidence), and lower risks of admission to hospital (0.37, 0.22 to 0.64; moderate quality evidence). The risk of a serious adverse event was similar between treatment and control groups (1.49, 0.24 to 9.35; low quality evidence). CONCLUSIONS:  Alpha blockers seem efficacious in the treatment of patients with ureteric stones who are amenable to conservative management. The greatest benefit might be among those with larger stones. These results support current guideline recommendations advocating a role for alpha blockers in patients with ureteric stones. SYSTEMATIC REVIEW REGISTRATION:  PROSPERO registration No CRD42015024169.

DNA from fecal immunochemical test can replace stool for detection of colonic lesions using a microbiota-based model.

BACKGROUND: There is a significant demand for colorectal cancer (CRC) screening methods that are noninvasive, inexpensive, and capable of accurately detecting early stage tumors. It has been shown that models based on the gut microbiota can complement the fecal occult blood test and fecal immunochemical test (FIT). However, a barrier to microbiota-based screening is the need to collect and store a patient's stool sample. RESULTS: Using stool samples collected from 404 patients, we tested whether the residual buffer containing resuspended feces in FIT cartridges could be used in place of intact stool samples. We found that the bacterial DNA isolated from FIT cartridges largely recapitulated the community structure and membership of patients' stool microbiota and that the abundance of bacteria associated with CRC were conserved. We also found that models for detecting CRC that were generated using bacterial abundances from FIT cartridges were equally predictive as models generated using bacterial abundances from stool. CONCLUSIONS: These findings demonstrate the potential for using residual buffer from FIT cartridges in place of stool for microbiota-based screening for CRC. This may reduce the need to collect and process separate stool samples and may facilitate combining FIT and microbiota-based biomarkers into a single test. Additionally, FIT cartridges could constitute a novel data source for studying the role of the microbiome in cancer and other diseases.

A Preoperative Risk Model for Postoperative Pneumonia After Coronary Artery Bypass Grafting.

BACKGROUND: Postoperative pneumonia is the most prevalent of all hospital-acquired infections after isolated coronary artery bypass graft surgery (CABG). Accurate prediction of a patient's risk of this morbid complication is hindered by its low relative incidence. In an effort to support clinical decision making and quality improvement, we developed a preoperative prediction model for postoperative pneumonia after CABG. METHODS: We undertook an observational study of 16,084 patients undergoing CABG between the third quarter of 2011 and the second quarter of 2014 across 33 institutions participating in the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Variables related to patient demographics, medical history, admission status, comorbid disease, cardiac anatomy, and the institution performing the procedure were investigated. Logistic regression through forward stepwise selection (p < 0.05 threshold) was utilized to develop a risk prediction model for estimating the occurrence of pneumonia. Traditional methods were used to assess the model's performance. RESULTS: Postoperative pneumonia occurred in 3.30% of patients. Multivariable analysis identified 17 preoperative factors, including demographics, laboratory values, comorbid disease, pulmonary and cardiac function, and operative status. The final model significantly predicted the occurrence of pneumonia, and performed well (C-statistic: 0.74). These findings were confirmed through sensitivity analyses by center and clinically important subgroups. CONCLUSIONS: We identified 17 readily obtainable preoperative variables associated with postoperative pneumonia. This model may be used to provide individualized risk estimation and to identify opportunities to reduce a patient's preoperative risk of pneumonia through prehabilitation.

Microbiota-based model improves the sensitivity of fecal immunochemical test for detecting colonic lesions.

BACKGROUND: Colorectal cancer (CRC) is the second leading cause of death among cancers in the United States. Although individuals diagnosed early have a greater than 90% chance of survival, more than one-third of individuals do not adhere to screening recommendations partly because the standard diagnostics, colonoscopy and sigmoidoscopy, are expensive and invasive. Thus, there is a great need to improve the sensitivity of non-invasive tests to detect early stage cancers and adenomas. Numerous studies have identified shifts in the composition of the gut microbiota associated with the progression of CRC, suggesting that the gut microbiota may represent a reservoir of biomarkers that would complement existing non-invasive methods such as the widely used fecal immunochemical test (FIT). METHODS: We sequenced the 16S rRNA genes from the stool samples of 490 patients. We used the relative abundances of the bacterial populations within each sample to develop a random forest classification model that detects colonic lesions using the relative abundance of gut microbiota and the concentration of hemoglobin in stool. RESULTS: The microbiota-based random forest model detected 91.7% of cancers and 45.5% of adenomas while FIT alone detected 75.0% and 15.7%, respectively. Of the colonic lesions missed by FIT, the model detected 70.0% of cancers and 37.7% of adenomas. We confirmed known associations of Porphyromonas assaccharolytica, Peptostreptococcus stomatis, Parvimonas micra, and Fusobacterium nucleatum with CRC. Yet, we found that the loss of potentially beneficial organisms, such as members of the Lachnospiraceae, was more predictive for identifying patients with adenomas when used in combination with FIT. CONCLUSIONS: These findings demonstrate the potential for microbiota analysis to complement existing screening methods to improve detection of colonic lesions.

Red Blood Cell Transfusions Impact Pneumonia Rates After Coronary Artery Bypass Grafting.

BACKGROUND: Pneumonia, a known complication of coronary artery bypass grafting (CABG), significantly increases a patient's risk of morbidity and mortality. Although not well characterized, red blood cell (RBC) transfusions may increase a patient's risk of pneumonia. We describe the relationship between RBC transfusion and postoperative pneumonia after CABG. METHODS: A total of 16,182 consecutive patients underwent isolated CABG between 2011 and 2013 at 1 of 33 hospitals in the state of Michigan. We used multivariable logistic regression to estimate the relative odds of pneumonia associated with the use or number of RBC units (0, 1, 2, 3, 4, 5, and ≥ 6). We adjusted for predicted risk of mortality, preoperative hematocrit values, history of pneumonia, cardiopulmonary bypass duration, and medical center. We confirmed the strength and direction of these relationships among selected clinical subgroups in a secondary analysis. RESULTS: Five hundred seventy-six (3.6%) patients had pneumonia and 6,451 (39.9%) received RBC transfusions. There was a significant association between any RBC transfusion and pneumonia (adjusted odds ratio [ORadj], 3.4; p < 0.001). There was a dose response between number of units and odds of pneumonia, with a ptrend less than 0.001. Patients receiving only 2 units of RBCs had a 2-fold (ORadj, 2.1; p < 0.001) increased odds of developing pneumonia. These findings were consistent across clinical subgroups. CONCLUSIONS: We found a significant volume-dependent association between an increasing number of RBCs and the odds of pneumonia, which persisted after risk adjustment. Clinical teams should explore opportunities for preventing a patient's risk of RBC transfusions, including reducing hemodilution or adopting a lower transfusion threshold in a stable patient.

Comparing the effectiveness of competing tests for reducing colorectal cancer mortality: a network meta-analysis.

BACKGROUND: Comparative effectiveness data pertaining to competing colorectal cancer (CRC) screening tests do not exist but are necessary to guide clinical decision making and policy. OBJECTIVE: To perform a comparative synthesis of clinical outcomes studies evaluating the effects of competing tests on CRC-related mortality. DESIGN: Traditional and network meta-analyses. Two reviewers identified studies evaluating the effect of guaiac-based fecal occult blood testing (gFOBT), flexible sigmoidoscopy (FS), or colonoscopy on CRC-related mortality. INTERVENTIONS: gFOBT, FS, colonoscopy. MAIN OUTCOME MEASUREMENTS: Traditional meta-analysis was performed to produce pooled estimates of the effect of each modality on CRC mortality. Bayesian network meta-analysis (NMA) was performed to indirectly compare the effectiveness of screening modalities. Multiple sensitivity analyses were performed. RESULTS: Traditional meta-analysis revealed that, compared with no intervention, colonoscopy reduced CRC-related mortality by 57% (relative risk [RR] 0.43; 95% confidence interval [CI], 0.33-0.58), whereas FS reduced CRC-related mortality by 40% (RR 0.60; 95% CI, 0.45-0.78), and gFOBT reduced CRC-related mortality by 18% (RR 0.82; 95% CI, 0.76-0.88). NMA demonstrated nonsignificant trends favoring colonoscopy over FS (RR 0.71; 95% CI, 0.45-1.11) and FS over gFOBT (RR 0.74; 95% CI, 0.51-1.09) for reducing CRC-related deaths. NMA-based simulations, however, revealed that colonoscopy has a 94% probability of being the most effective test for reducing CRC mortality and a 99% probability of being most effective when the analysis is restricted to screening studies. LIMITATIONS: Randomized trials and observational studies were combined within the same analysis. CONCLUSION: Clinical outcomes studies demonstrate that gFOBT, FS, and colonoscopy are all effective in reducing CRC-related mortality. Network meta-analysis suggests that colonoscopy is the most effective test.

The human gut microbiome as a screening tool for colorectal cancer.

Recent studies have suggested that the gut microbiome may be an important factor in the development of colorectal cancer. Abnormalities in the gut microbiome have been reported in patients with colorectal cancer; however, this microbial community has not been explored as a potential screen for early-stage disease. We characterized the gut microbiome in patients from three clinical groups representing the stages of colorectal cancer development: healthy, adenoma, and carcinoma. Analysis of the gut microbiome from stool samples revealed both an enrichment and depletion of several bacterial populations associated with adenomas and carcinomas. Combined with known clinical risk factors of colorectal cancer (e.g., BMI, age, race), data from the gut microbiome significantly improved the ability to differentiate between healthy, adenoma, and carcinoma clinical groups relative to risk factors alone. Using Bayesian methods, we determined that using gut microbiome data as a screening tool improved the pretest to posttest probability of adenoma more than 50-fold. For example, the pretest probability in a 65-year-old was 0.17% and, after using the microbiome data, this increased to 10.67% (1 in 9 chance of having an adenoma). Taken together, the results of our study demonstrate the feasibility of using the composition of the gut microbiome to detect the presence of precancerous and cancerous lesions. Furthermore, these results support the need for more cross-sectional studies with diverse populations and linkage to other stool markers, dietary data, and personal health information.

Health care-associated infection after red blood cell transfusion: a systematic review and meta-analysis.

IMPORTANCE: The association between red blood cell (RBC) transfusion strategies and health care-associated infection is not fully understood. OBJECTIVE: To evaluate whether RBC transfusion thresholds are associated with the risk of infection and whether risk is independent of leukocyte reduction. DATA SOURCES: MEDLINE, EMBASE, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, Cochrane Database of Sytematic Reviews, ClinicalTrials.gov, International Clinical Trials Registry, and the International Standard Randomized Controlled Trial Number register were searched through January 22, 2014. STUDY SELECTION: Randomized clinical trials with restrictive vs liberal RBC transfusion strategies. DATA EXTRACTION AND SYNTHESIS: Twenty-one randomized trials with 8735 patients met eligibility criteria, of which 18 trials (n = 7593 patients) contained sufficient information for meta-analyses. DerSimonian and Laird random-effects models were used to report pooled risk ratios. Absolute risks of infection were calculated using the profile likelihood random-effects method. MAIN OUTCOMES AND MEASURES: Incidence of health care-associated infection such as pneumonia, mediastinitis, wound infection, and sepsis. RESULTS: The pooled risk of all serious infections was 11.8% (95% CI, 7.0%-16.7%) in the restrictive group and 16.9% (95% CI, 8.9%-25.4%) in the liberal group. The risk ratio (RR) for the association between transfusion strategies and serious infection was 0.82 (95% CI, 0.72-0.95) with little heterogeneity (I2 = 0%; τ2 <.0001). The number needed to treat (NNT) with restrictive strategies to prevent serious infection was 38 (95% CI, 24-122). The risk of infection remained reduced with a restrictive strategy, even with leukocyte reduction (RR, 0.80 [95% CI, 0.67-0.95]). For trials with a restrictive hemoglobin threshold of <7.0 g/dL, the RR was 0.82 (95% CI, 0.70-0.97) with NNT of 20 (95% CI, 12-133). With stratification by patient type, the RR was 0.70 (95% CI, 0.54-0.91) in patients undergoing orthopedic surgery and 0.51 (95% CI, 0.28-0.95) in patients presenting with sepsis. There were no significant differences in the incidence of infection by RBC threshold for patients with cardiac disease, the critically ill, those with acute upper gastrointestinal bleeding, or for infants with low birth weight. CONCLUSIONS AND RELEVANCE: Among hospitalized patients, a restrictive RBC transfusion strategy was associated with a reduced risk of health care-associated infection compared with a liberal transfusion strategy. Implementing restrictive strategies may have the potential to lower the incidence of health care-associated infection.

Reducing unnecessary urinary catheter use and other strategies to prevent catheter-associated urinary tract infection: an integrative review.

BACKGROUND: Catheter-associated urinary tract infections (CAUTI) are costly, common and often preventable by reducing unnecessary urinary catheter (UC) use. METHODS: To summarise interventions to reduce UC use and CAUTIs, we updated a prior systematic review (through October 2012), and a meta-analysis regarding interventions prompting UC removal by reminders or stop orders. A narrative review summarises other CAUTI prevention strategies including aseptic insertion, catheter maintenance, antimicrobial UCs, and bladder bundle implementation. RESULTS: 30 studies were identified and summarised with interventions to prompt removal of UCs, with potential for inclusion in the meta-analyses. By meta-analysis (11 studies), the rate of CAUTI (episodes per 1000 catheter-days) was reduced by 53% (rate ratio 0.47; 95% CI 0.30 to 0.64, p<0.001) using a reminder or stop order, with five studies also including interventions to decrease initial UC placement. The pooled (nine studies) standardised mean difference (SMD) in catheterisation duration (days) was -1.06 overall (p=0.065) including a statistically significant decrease in stop-order studies (SMD -0.37; p<0.001) but not in reminder studies (SMD, -1.54; p=0.071). No significant harm from catheter removal strategies is supported. Limited research is available regarding the impact of UC insertion and maintenance technique. A recent randomised controlled trial indicates antimicrobial catheters provide no significant benefit in preventing symptomatic CAUTIs. CONCLUSIONS: UC reminders and stop orders appear to reduce CAUTI rates and should be used to improve patient safety. Several evidence-based guidelines have evaluated CAUTI preventive strategies as well as emerging evidence regarding intervention bundles. Implementation strategies are important because reducing UC use involves changing well-established habits.

Determining the noninfectious complications of indwelling urethral catheters: a systematic review and meta-analysis.

BACKGROUND: Although the epidemiology of catheter-associated urinary tract infection is well-described, little is known about noninfectious complications resulting from urethral catheter use. PURPOSE: To determine the frequency of noninfectious complications after catheterization. DATA SOURCES: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL, Conference Papers Index, BIOSIS Previews, Scopus, and ClinicalTrials.gov were searched for human studies without any language limits and through 30 July 2012. STUDY SELECTION: Clinical trials and observational studies assessing noninfectious complications of indwelling urethral catheters in adults. DATA EXTRACTION: Relevant studies were sorted into 3 categories: short-term catheterization in patients without spinal cord injury (SCI), long-term catheterization in patients without SCI, and catheterization in patients with SCI. The proportion of patients who had bladder cancer, bladder stones, blockage, false passage, gross hematuria, accidental removal, urine leakage, or urethral stricture was then pooled using random-effects models. DATA SYNTHESIS: Thirty-seven studies (2868 patients) were pooled. Minor complications were common. For example, the pooled frequency of urine leakage ranged from 10.6% (95% CI, 2.4% to 17.7%) in short-term catheterization cohorts to 52.1% (CI, 28.6% to 69.5%) among outpatients with long-term indwelling catheters. Serious complications were also noted, including urethral strictures, which occurred in 3.4% (CI, 1.0% to 7.0%) of patients with short-term catheterization. For patients with SCI, 13.5% (CI, 3.4% to 21.9%) had gross hematuria and 1.0% (CI, 0.0% to 5.0%) developed bladder cancer. LIMITATIONS: Although heterogeneity existed across studies for several outcomes, most could be accounted for by differences between studies with respect to quality and sex composition. Evidence published after 30 July 2012 is not included. CONCLUSION: Many noninfectious catheter-associated complications are at least as common as clinically significant urinary tract infections. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Higher rates of Clostridium difficile infection among smokers.

OBJECTIVES: Cigarette smoking has been shown to be related to inflammatory bowel disease. We investigated whether smoking affected the probability of developing Clostridium difficile infection (CDI). METHODS: We conducted a longitudinal study of 16,781 older individuals from the nationally representative Health and Retirement Study. Data were linked to files from the Centers for Medicare and Medicaid Services. RESULTS: Overall, the rate of CDI in older individuals was 220.6 per 100,000 person-years (95% CI 193.3, 248.0). Rates of CDI were 281.6/100,000 person-years in current smokers, 229.0/100,000 in former smokers and 189.1/100,000 person-years in never smokers. The odds of CDI were 33% greater in former smokers (95% CI: 8%, 65%) and 80% greater in current smokers (95% CI: 33%, 145%) when compared to never smokers. When the number of CDI-related visits was evaluated, current smokers had a 75% increased rate of CDI compared to never smokers (95% CI: 15%, 167%). CONCLUSIONS: Smoking is associated with developing a Clostridium difficile infection. Current smokers have the highest risk, followed by former smokers, when compared to rates of infection in never smokers.

Triggers of hospitalization for venous thromboembolism.

BACKGROUND: The rate of hospitalization for venous thromboembolism (VTE) is increasing in the United States. Although predictors of hospital-acquired VTE are well-known, triggers of VTE before hospitalization are not as clearly defined. The objective of this study was to evaluate triggers of hospitalization for VTE. METHODS AND RESULTS: A case-crossover study was conducted. Subjects were participants in the Health and Retirement Study, a nationally representative sample of older Americans. Data were linked to Medicare files for hospital and nursing home stays, emergency department visits, outpatient visits including physician visits, and home health visits from years 1991 to 2007 (n=16 781). The outcome was hospitalization for venous thromboembolism (n=399). Exposures during the 90-day period before hospitalization for VTE were compared with exposures occurring in 4 comparison periods. Infection was the most common trigger of hospitalization for VTE, occurring in 52.4% of the risk periods before hospitalization. The adjusted incidence rate ratios (IRRs; 95% confidence interval) were 2.90 (2.13, 3.94) for all infection, 2.63 (1.90, 3.63) for infection without a previous hospital or skilled nursing facility stay, and 6.92 (4.46, 10.72) for infection with a previous hospital or skilled nursing facility stay. Erythropoiesis-stimulating agents and blood transfusion were also associated with VTE hospitalization (IRR=9.33, 95% confidence interval: 1.19, 73.42; IRR=2.57, 95% confidence interval: 1.17, 5.64; respectively). Other predictors included major surgeries, fractures (IRR=2.81), immobility (IRR=4.23), and chemotherapy (IRR=5.70). These predictors, combined, accounted for a large proportion (69.7%) of exposures before VTE hospitalization as opposed to 35.3% in the comparison periods. CONCLUSIONS: Risk prediction algorithms for VTE should be reevaluated to include infection, erythropoiesis-stimulating agents, and blood transfusion.

Utilization of blood transfusion among older adults in the United States.

BACKGROUND: While there have been epidemiologic studies of blood donors, the characteristics of individuals who receive transfusions have not been well described for the US population. STUDY DESIGN AND METHODS: Subjects were from the nationally representative Health and Retirement Study whose data were linked to Medicare files from 1991 through 2007 (n = 16,377). A cohort study was conducted to assess the frequency of transfusion in older Americans over time and to describe the characteristics of blood recipients. RESULTS: Thirty-one percent (95% confidence interval [CI], 30%-33%) of older Americans received at least one transfusion within a 10-year period and 5.8% (95% CI, 5.4%-6.2%) experienced repeated transfusion-related visits within 30 days. The mean number of transfusion-related visits was 2.3 over a 10-year period (95% CI, 2.2-2.4). Older Americans who lived in the South were most likely to receive a transfusion (34%), independent of demographic and health-related factors, while those who lived in the western United States were the least likely (26%). Predictors of transfusion included smoking, low body mass index, and a history of cancer, diabetes mellitus, end-stage renal disease, and heart disease. African-Americans and Mexican-Americans had greater rates of blood utilization than other races and other Hispanics (respectively). There were also differences in transfusion utilization by education, marital status, religion, and alcohol use. CONCLUSIONS: Transfusion is common in older Americans. Regional variations in blood use are not explained by patient characteristics alone.

Liability claims and costs before and after implementation of a medical error disclosure program.

BACKGROUND: Since 2001, the University of Michigan Health System (UMHS) has fully disclosed and offered compensation to patients for medical errors. OBJECTIVE: To compare liability claims and costs before and after implementation of the UMHS disclosure-with-offer program. DESIGN: Retrospective before-after analysis from 1995 to 2007. SETTING: Public academic medical center and health system. PATIENTS: Inpatients and outpatients involved in claims made to UMHS. MEASUREMENTS: Number of new claims for compensation, number of claims compensated, time to claim resolution, and claims-related costs. RESULTS: After full implementation of a disclosure-with-offer program, the average monthly rate of new claims decreased from 7.03 to 4.52 per 100,000 patient encounters (rate ratio [RR], 0.64 [95% CI, 0.44 to 0.95]). The average monthly rate of lawsuits decreased from 2.13 to 0.75 per 100,000 patient encounters (RR, 0.35 [CI, 0.22 to 0.58]). Median time from claim reporting to resolution decreased from 1.36 to 0.95 years. Average monthly cost rates decreased for total liability (RR, 0.41 [CI, 0.26 to 0.66]), patient compensation (RR, 0.41 [CI, 0.26 to 0.67]), and non-compensation-related legal costs (RR, 0.39 [CI, 0.22 to 0.67]). LIMITATIONS: The study design cannot establish causality. Malpractice claims generally declined in Michigan during the latter part of the study period. The findings might not apply to other health systems, given that UMHS has a closed staff model covered by a captive insurance company and often assumes legal responsibility. CONCLUSION: The UMHS implemented a program of full disclosure of medical errors with offers of compensation without increasing its total claims and liability costs. PRIMARY FUNDING SOURCE: Blue Cross Blue Shield of Michigan Foundation.

Outcomes of transvaginal uterosacral ligament suspension: systematic review and metaanalysis.

This systematic review of uterosacral ligament suspension provides a metaanalysis of anatomic outcomes and a summary of subjective outcomes. A successful anatomic outcome was considered present when women had "optimal" or "satisfactory" (pelvic organ prolapse quantification system stage 0 or 1) outcomes. In the anterior, apical, and posterior compartments, the pooled rates for a successful outcome were 81.2% (95% confidence interval [CI], 67.5-94.5%), 98.3% (95% CI, 95.7-100%), and 87.4% (95% CI, 67.5-94.5%). In the anterior compartment, women with preoperative stage 2 prolapse were more likely than those with preoperative stage 3 prolapse to have a successful anatomic outcome (92.4% vs 66.8%; P = .06). Outcomes, with respect to subjective symptoms, were reassuring; however, it was not possible to pool data because of methodologic differences between studies.