Data Sharing Between Providers and Quality Initiatives Eliminate Unnecessary Nursing Home Admissions.

BACKGROUND: The Michigan Arthroplasty Registry Collaborative Quality Initiative (MARCQI) has monitored discharge disposition, after total hip and knee arthroplasties, since inception in 2012 and found the standardized risk of extended care facility (ECF) placement to be highly variable between hospitals. METHODS: The variation in standardized risks of ECF placement among MARCQI member sites was reported to the collaborative. At the May 2, 2014 quarterly meeting, a quality initiative was started, emphasizing the wide variability between hospitals, the contribution of hospital and surgeon to that variability using median odds ratios, and the need for outlier hospitals to initiate quality improvement (QI) processes. Patients from 29 hospitals that were members of MARCQI before the intervention were included in this analysis. We compared standardized risks before and after the intervention in the entire cohort, and for 3 hospitals that implemented institution-specific QI projects. We report changes in ECF placement, length of stay, emergency room visits, and readmissions over time. RESULTS: This study includes 31,347 patients before and 20,879 patients after the implementation of the quality initiative. The range in standardized risk dropped from 9.4%-46.1% to 9.4%-32.4% and the average dropped from 23.0% to 19.6%. Three outlier hospitals decreased their absolute risk of ECF placement by 12.2%, 8.9%, and 12.4% after QI, without increases in adverse outcomes. CONCLUSION: Discharge to ECF after primary hip and knee arthroplasties is highly variable and influenced by hospital and surgeon practices. Hospital-level QI measures can decrease ECF admissions.

Quality Initiative Programs Can Decrease Total Joint Arthroplasty Transfusion Rates-A Multicenter Study Using the MARCQI Total Joint Registry Database.

BACKGROUND: The Michigan Arthroplasty Registry Collaborative Quality Initiative (MARCQI) noted wide variability between member hospitals in blood transfusion rates after primary total hip and knee arthroplasty (THA and TKA). Blood transfusion has substantial risks and accepted recommendations exist to guide transfusion practices. MARCQI began an initiative to decrease unnecessary transfusions by identifying/reporting outliers, discussing conservative transfusion practices, and recommending transfusion guidelines. There was a later recommendation to consider intraoperative use of tranexamic acid. METHODS: All MARCQI-registered unilateral TKA and THA cases from the 28 member hospitals (pre-November 2013) were included. For 3 time periods (before November 13, 2013; November 13, 2013, to November 12, 2014; and after November 12, 2014), we calculated average risk and range of transfusion, transfusion with nadir hemoglobin >8 g/dL, mean length of stay, and 90-day risk of discharge to nursing home, readmission, deep infection, and emergency department visits. RESULTS: For THA, risk and range of transfusion decreased over the 3 time periods: 12.6% (2.5%-36.2%), 7.6% (2.2%-23.8%), and 4.5% (0.7%-14.4%); for TKA, 6.3% (1.3%-15.6%), 3.1% (0%-12.5%), and 1.3% (0%-7.4%). Decreases were also noted for transfusion with a nadir hemoglobin >8 g/dL with a near elimination of "unnecessary" transfusions. There was no evidence of increase in length of stay, discharge to nursing home, readmission, deep infection, or emergency department visits. CONCLUSION: A simple intervention can decrease unnecessary blood transfusions during and after elective primary unilateral THA or TKA. A collaborative registry can be used effectively to improve the quality of patient care and set a new benchmark for transfusion.

(1,3)-ß-d-glucan in cerebrospinal fluid for diagnosis of fungal meningitis associated with contaminated methylprednisolone injections.

Prompt diagnosis and treatment of fungal meningitis are critical, but culture is insensitive. (1,3)-ß-d-Glucan (BDG) testing is FDA approved for serological diagnosis of invasive fungal disease; however, BDG testing is not approved for cerebrospinal fluid (CSF), and the appropriate cutoff value is unknown. We aimed to validate the diagnostic accuracy of CSF BDG measurements for fungal meningitis among patients exposed to contaminated methylprednisolone acetate (MPA). A retrospective observational study was conducted at St. Joseph Mercy Hospital and Vanderbilt University from November 2013 to February 2014. Patients were included if they had received a contaminated MPA injection. Cases were classified as probable or proven meningitis according to Centers for Disease Control and Prevention guidelines. CSF BDG testing was performed according to the package insert instructions for serum samples, and results were validated using Clinical and Laboratory Standards Institute procedures (MiraVista Diagnostics). Of 233 patients, 45 had meningitis (28 proven cases), 53 had spinal/paraspinal infections (19 proven cases), and 135 did not develop disease. Using the manufacturer's cutoff value (≥80 pg/ml), the sensitivity and specificity were 96% and 95%, respectively, for proven meningitis and 84% and 95% for probable or proven meningitis. Receiver operating characteristic analysis identified the optimal cutoff value for proven meningitis to be 66 pg/ml (sensitivity, 100%; specificity, 94%) and that for probable or proven meningitis to be 66 pg/ml (sensitivity, 91%; specificity, 92%). Our results suggest that CSF BDG measurements are highly sensitive and specific for the diagnosis of fungal meningitis associated with contaminated MPA injections. Further study on the utility of CSF BDG testing for other types of fungal meningitis is needed.

Reference range for tissue oxygen saturation in pregnancy using near-infrared spectroscopy.

OBJECTIVE: To estimate the reference range of tissue oxygen saturation (StO2) values in pregnancy. Near-infrared spectroscopy-derived StO2 is a noninvasive continuous measure used to predict hypoperfusion. Normal StO2 values have not been established in pregnant women. STUDY DESIGN: We enrolled 154 healthy pregnant women from an obstetric and gynecology resident clinic. Three sequential measurements were taken after securing the StO2 probe to the thenar eminence of one hand. One-way ANOVA was used to test for differences between trimesters and non-parametric methods to establish a reference range with 95% CI on the limits. RESULTS: The reference interval for the entire cohort of pregnant women is 73% (95% CI 72-75) to 92% (95% CI 89-93), similar to the normal range in the general population. We found no statistically significant difference in StO2 measurements between trimesters. Due to inadequate sample sizes we could not estimate a valid reference range for each trimester. CONCLUSION: We estimated a reference range for StO2 values in normal pregnant women. This information may contribute to the study of StO2 monitoring to predict impending shock in the obstetric patient.

Alopecia and nail changes associated with voriconazole therapy.

BACKGROUND: Voriconazole was 1 of 2 antifungal agents recommended for treatment of fungal infections associated with injection of contaminated methylprednisolone. Alopecia and nail changes are not commonly reported side effects of voriconazole. Having noted increasing hair loss among our patients treated with voriconazole, we sought to determine the prevalence and characteristics of alopecia associated with this agent. METHODS: Patients who received voriconazole for at least 1 month for probable or confirmed fungal infection were eligible to complete a survey regarding alopecia and nail changes. For those patients who reported alopecia, additional questions about reversal of hair loss were asked after voriconazole had been stopped for at least 3 months. RESULTS: A total of 152 of 175 eligible patients (87%) completed the survey. One hundred twenty-five (82%) reported alopecia. Hair loss on the scalp was noted in 120 (96%), arms and legs in 52 (42%), and eyebrows and eyelashes in 47 each (38%). Nineteen patients (15%) reported wearing a wig or hat because of extensive hair loss. Alopecia developed a mean (standard deviation) of 75 (54) days after initiation of voriconazole. Of 114 patients who were off voriconazole for at least 3 months, hair loss had stopped in 94 (82%) and regrowth had begun in 79 (69%), including those who were changed to either itraconazole or posaconazole. Nail changes or loss occurred in 106 (70%) patients. CONCLUSIONS: Alopecia and nail changes were common adverse effects associated with voriconazole therapy during the multistate fungal outbreak.

Impact of a new senior emergency department on emergency department recidivism, rate of hospital admission, and hospital length of stay.

STUDY OBJECTIVE: Senior (geriatric) emergency departments (EDs) are an emerging phenomenon across the United States, designed to provide greater comfort for elders, screening for common morbidities, and selective contact with social workers. We hypothesize that the senior ED will reduce recidivism, rate of admission, and hospital length of stay. METHODS: This was a pre/postintervention observational study of seniors (≥65 years) before and after opening of a new senior ED in a large community hospital. Older nonseniors treated during the same periods were included to detect temporal trend bias. Outcomes included admission to the hospital, hospital length of stay, and ED return visits. Cox proportional hazards models, controlling for patient age, sex, triage level, insurance type, admission on the index visit, and hospital length of stay, were used to test association with time to return within 30 and 180 days. Multivariable regression modeling was used to determine whether the intervention was associated with admission on the index visit, and hospital length of stay. RESULTS: There was no significant difference in time to return within 30 days (HR=1.09; 95% confidence interval [CI] 0.95 to 1.23), 180 days (HR=0.99; 95% CI 0.91 to 1.08), or average hospital length of stay. Risk of being admitted on the index visit was lower for seniors treated in the senior ED compared with the regular ED (Relative Risk=0.93; 95% CI 0.89 to 0.98). CONCLUSION: A new senior ED was not associated with reduced ED recidivism or hospital length of stay, but was associated with decreased rate of admission.

Implementation of a novel communication tool and its effect on patient comprehension of care and satisfaction.

BACKGROUND: Emergency department (ED) communication has been demonstrated as requiring improvement and ED patients have repeatedly demonstrated poor comprehension of the care they receive. Through patient focus groups, the authors developed a novel tool designed to improve communication and patient comprehension. STUDY DESIGN: This is a prospective, randomised controlled clinical trial to test the efficacy of a novel, patient-centred communication tool. Patients in a small community hospital ED were randomised to receive the instrument, which was utilised by the entire ED care team and served as a checklist or guide to the patients' ED stay. At the end of the ED stay, patients completed a survey of their comprehension of the care and a communication assessment tool-team survey (a validated instrument to assess satisfaction with communication). Three blinded chart reviewers scored patients' comprehension of their ED care as concordant, partially concordant or discordant with charted care. The authors tested whether there was a difference in satisfaction using a two-sample t test and a difference in comprehension using ordinal logistic regression analysis. RESULTS: 146 patients were enrolled in the study with 72 randomised to receive the communication instrument. There was no significant difference between groups in comprehension (OR=0.65, 95% CI 0.34 to 1.23, p=0.18) or communication assessment tool-team scores (difference=0.2, 95% CI: -3.4 to 3.8, p=0.91). CONCLUSIONS: Using their novel communication tool, the authors were not able to show a statistically significant improvement in either comprehension or satisfaction, though a tendency towards improved comprehension was seen.

Magnetic resonance imaging screening to identify spinal and paraspinal infections associated with injections of contaminated methylprednisolone acetate.

IMPORTANCE: Injection of contaminated methylprednisolone has resulted in an unprecedented nationwide outbreak of Exserohilum rostratum fungal infections, manifested initially as meningitis and/or basilar stroke. Insidious onset of spinal or paraspinal infection at the injection site has been increasingly reported and is occurring months after receipt of injection with the contaminated drug. The clinical findings are often subtle and similar to those that led the patient to undergo the methylprednisolone injection. OBJECTIVE: To determine if patients who had not presented for medical care but who had received contaminated methylprednisolone developed spinal or paraspinal infection at the injection site using contrast-enhanced magnetic resonance imaging (MRI) screening. DESIGN, SETTING, AND PARTICIPANTS: There were 172 patients who had received an injection of contaminated methylprednisolone from a highly contaminated lot (No. 06292012@26) at a pain facility but had not presented for medical care related to adverse effects after the injection. Screening MRI was performed between November 9, 2012, and April 30, 2013. MAIN OUTCOMES AND MEASURES: Number of persons identified with previously undiagnosed spinal or paraspinal infection. RESULTS: Of the 172 patients screened, MRI was abnormal in 36 (21%), showing epidural or paraspinal abscess or phlegmon, arachnoiditis, spinal osteomyelitis or diskitis, or moderate to severe epidural, paraspinal, or intradural enhancement. Of the 115 patients asked about new or worsening back or neck pain, lower extremity weakness, or radiculopathy symptoms, 35 (30%) had at least 1 symptom. Thirty-five of the 36 patients with abnormal MRIs met the Centers for Disease Control and Prevention (CDC) case definition for probable (17 patients) or confirmed (18 patients) fungal spinal or paraspinal infection. All 35 patients were treated with antifungal agents (voriconazole, with or without liposomal amphotericin B), and 24 required surgical debridement. At the time of surgery, 17 of 24 patients (71%), including 5 patients who denied having symptoms, had laboratory evidence of fungal infection. CONCLUSIONS AND RELEVANCE: Among patients who underwent screening MRI to look for infection at the site of injection of contaminated methylprednisolone, 21% had an abnormal MRI, and all but one met CDC criteria for probable or confirmed fungal spinal or paraspinal infection. Screening MRI led to identification of patients who had minimal or no symptoms of spinal or paraspinal infection and allowed early initiation of medical and surgical treatment.

Does intrathecal morphine sulfate provide preemptive analgesia for patients undergoing stapled hemorrhoidopexy?

OBJECTIVE: Surgical excision of hemorrhoids is characterized by a prolonged and painful postoperative course. This double-blind, randomized, prospective, controlled trial was conducted to determine if morphine sulfate provides additional pain relief after stapled hemorrhoidopexy when added to a standard lidocaine spinal anesthetic. It was hypothesized that the addition of morphine sulfate to a spinal anesthetic would decrease postoperative pain. INTERVENTIONS: Thirty-four patients were randomized prospectively to receive a spinal block with either lidocaine or lidocaine plus morphine sulfate. Patients were followed postoperatively for 42 days to record Numeric Pain Scale (NPS) values and to record analgesic use. Patients also filled out a Short Form 36 (SF-36) Health Survey Questionnaire preoperatively and at days 3, 14, and 28 after their operation to assess physical and mental well-being. Longitudinal mixed models were used to determine whether there was a difference in maximum pain, average pain, narcotic analgesic use, and physical or mental well-being over time. RESULTS: No group differences were found in maximum or average NPS, analgesic use, mental well-being, or time to complete pain relief. There was a four-point difference in mean scores for physical well-being, favoring the lidocaine plus morphine group. CONCLUSIONS: This study provides evidence that intrathecal morphine sulfate does not significantly alter postoperative pain, narcotic use, or well-being when used as preemptive analgesia for patients undergoing stapled hemorrhoidopexy.

The inability of B-type natriuretic protein to predict short-term risk of death or myocardial infarction in non-heart-failure patients with marginally increased troponin levels.

STUDY OBJECTIVE: We want to know whether a low B-type natriuretic peptide (BNP) level, obtained shortly after presentation and independent of information provided by other clinical findings and laboratory tests, would affect management decisions for emergency department (ED) patients with nondiagnostic troponin levels. Previous studies have generally been retrospective or inclusive of patients with heart failure. METHODS: We prospectively studied patients evaluated for possible acute coronary syndromes who had nondiagnostic levels of serum troponin, nondiagnostic ECGs, and no clinical heart failure within 4 hours of presentation. BNP levels were obtained but results not provided to clinical staff. The primary outcome was the composite of acute myocardial infarction or death within 30 days. The secondary outcome was the composite of the primary outcome, percutaneous coronary intervention, or coronary artery bypass grafting. RESULTS: Almost half of the patients screened for but excluded from the study had known heart failure or a history of heart failure. The resulting cohort was composed of 348 patients, with a median age of 64 years and 51% women. The primary outcome occurred in 16.1% of patients; the secondary outcome, in 27.6%. At a standard cutoff of BNP greater than or equal to 80 pg/mL, the negative predictive value for the primary outcome was 80% (95% confidence interval 73% to 86%). The negative predictive value for the secondary outcome was 69% (95% confidence interval 61% to 75%). Multivariable analyses supported these findings. CONCLUSION: A single, low BNP level obtained shortly after presentation to the ED could not identify patients at low risk for 30-day acute myocardial infarction or death.

Laparotomy operative note template constructed through a modified Delphi method.

OBJECTIVE: An operative note is indispensable to physician documentation and decision-making; however, there are no accepted standards for operative note content. Our aim was to use a modified Delphi consensus-building method to construct a uniform operative note template for laparotomy. STUDY DESIGN: Using Joint Commission on Accreditation of Healthcare Organizations requirements, literature review, and feedback from 15 medical malpractice defense attorneys, we compiled a draft operative note template of 31 elements. We surveyed 37 Association of Professor of Gynecology and Obstetrics/Solvay scholars asking for their input on inclusion of each item as essential content of the operative note. RESULTS: Two iterations of the survey were required to reach a predetermined 75% level of consensus. Nine elements were eliminated from the template: 6 original and 3 expert-suggested elements. CONCLUSION: We provide an operative note template that was compiled through a Delphi process.

The efficacy of the surgical delay procedure in pedicle TRAM breast reconstruction.

Although experimental evidence suggests that the preliminary surgical delay procedure physiologically improves the circulation of the TRAM flap, there are no published controlled studies evaluating the clinical outcomes associated with this procedure. The purpose of this study was to evaluate the efficacy of the surgical flap delay versus no delay in consecutive patients having pedicle TRAM breast reconstruction. This was a retrospective cohort study of breast cancer patients at the University of Michigan who had pedicle TRAM reconstruction between January 2004 and March 2008. Prior to September 2005, all patients had pedicle TRAM reconstruction without the delay procedure. Starting in September 2005, all patients had the delay procedure prior to TRAM flap reconstruction. Descriptive statistics were used to compare demographic data, comorbidities, and complication rates between the 2 cohorts. Regression analysis was used to determine the effects of the surgical delay procedure on the incidence of flap ischemia and major and minor complications while controlling for patient and treatment level factors. Eighty-seven postmastectomy breast cancer patients had unipedicle TRAM flap reconstruction, in which 112 flaps were used to reconstruct breasts. The nondelay cohort consisted of 42 consecutive patients (51 flaps) and the delay cohort consisted of 45 consecutive patients (61 flaps). Of the patients without the surgical delay procedure 17.6% experienced at least one ischemic complication of the flap compared with 6.6% of those who were surgically delayed (P = 0.082). When controlling for patient and treatment level factors, the delay procedure was found to significantly decrease the incidence of flap ischemia (OR = 0.21, P = 0.018). In addition, there were no significant differences in the incidence of major or minor complication rates in the surgically delayed versus nondelayed groups (P = 0.247, P = 0.486, respectively). When patient and treatment level factors were taken into consideration, undergoing the delay procedure also did not increase the incidence of having a major or minor complication. These data support the use of the preliminary surgical delay procedure to decrease ischemic complications of the flap in pedicle TRAM postmastectomy breast reconstruction.

Association of Aspirin With Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty Compared With Other Anticoagulants: A Noninferiority Analysis.

Importance: There has been significant debate in the surgical and medical communities regarding the appropriateness of using aspirin alone for venous thromboembolism (VTE) prophylaxis following total knee arthroplasty (TKA). Objective: To determine the acceptability of aspirin alone vs anticoagulant prophylaxis for reducing the risk of postoperative VTE in patients undergoing TKA. Design, Setting, and Participants: Noninferiority study of a retrospective cohort of TKA cases submitted to the Michigan Arthroplasty Registry Collaborative Quality Initiative at 29 member hospitals, ranging from small community hospitals to large academic and nonacademic medical centers in Michigan. The study included 41 537 patients who underwent primary TKA between April 1, 2013, and October 31, 2015. Clinical events were monitored for 90 days after surgery. Data were analyzed between September and October 2016. Exposures: The method of pharmacologic prophylaxis: neither aspirin nor anticoagulants for 668 patients (1.6%), aspirin only for 12 831 patients (30.9%), anticoagulant only (eg, low-molecular-weight heparin, warfarin, and Xa inhibitors) for 22 620 patients (54.5%), and both aspirin/anticoagulant for 5418 patients (13.0%). Most patients were also using intermittent pneumatic compression stockings. Main Outcome and Measures: The primary composite outcome was the first occurrence of VTE or death. The noninferiority margin was specified as 0.3. The secondary outcome was bleeding events. Results: Of the 41 537 patients, 14 966 were men (36%), and the mean age was 65.8 years. A VTE event occurred in 573 of 41 537 patients (1.38%); 32 of 668 (4.79%) who received no pharmacologic prophylaxis, 149 of 12 831 (1.16%) treated with aspirin alone, 321 of 22 620 (1.42%) with anticoagulation alone, and 71 of 5418 (1.31%) prescribed both aspirin and anticoagulation. Aspirin only was noninferior for the composite VTE outcome compared with those receiving other chemoprophylaxis (adjusted odds ratio, 0.85; 95% CI, 0.68-1.07, P for inferiority = .007). Bleeding occurred in 457 of 41 537 patients (1.10%), 10 of 668 (1.50%) without prophylaxis, 116 of 12 831 (0.90%) in the aspirin group, 258 of 22 620 (1.14%) with anticoagulation, and 73 of 5418 (1.35%) of those receiving both. Aspirin alone was also noninferior for bleeding complications (adjusted odds ratio, 0.80; 95% CI, 0.63-1.00, P for inferiority <.001). Conclusions and Relevance: In this study of patients undergoing TKA, aspirin was not inferior to other anticoagulants in the postoperative rate of VTE or death. Aspirin alone may provide similar protection from postoperative VTE compared with other anticoagulation treatments.

A single factor underlies the metabolic syndrome: a confirmatory factor analysis.

OBJECTIVE: Confirmatory factor analysis (CFA) was used to test the hypothesis that the components of the metabolic syndrome are manifestations of a single common factor. RESEARCH DESIGN AND METHODS: Three different datasets were used to test and validate the model. The Spanish and Mauritian studies included 207 men and 203 women and 1,411 men and 1,650 women, respectively. A third analytical dataset including 847 men was obtained from a previously published CFA of a U.S. population. The one-factor model included the metabolic syndrome core components (central obesity, insulin resistance, blood pressure, and lipid measurements). We also tested an expanded one-factor model that included uric acid and leptin levels. Finally, we used CFA to compare the goodness of fit of one-factor models with the fit of two previously published four-factor models. RESULTS: The simplest one-factor model showed the best goodness-of-fit indexes (comparative fit index 1, root mean-square error of approximation 0.00). Comparisons of one-factor with four-factor models in the three datasets favored the one-factor model structure. The selection of variables to represent the different metabolic syndrome components and model specification explained why previous exploratory and confirmatory factor analysis, respectively, failed to identify a single factor for the metabolic syndrome. CONCLUSIONS: These analyses support the current clinical definition of the metabolic syndrome, as well as the existence of a single factor that links all of the core components.

Methylphenidate and cocaine: a placebo-controlled drug interaction study.

Up to thirty percent of cocaine addicted individuals may meet diagnostic criteria for Attention-Deficit/Hyperactivity Disorder (ADHD). Methylphenidate (MPH) is a highly effective and commonly used treatment for ADHD but, like cocaine, is a cardiovascular and central nervous system stimulant with the potential to cause toxicity at high doses. The present study was undertaken to investigate the likelihood of a toxic reaction in individuals who use cocaine while concurrently taking MPH. Seven non-treatment seeking cocaine-dependent individuals completed this placebo-controlled, crossover study with two factors: Medication (placebo, 60 mg MPH, 90 mg MPH) and Infusion (saline, 20 mg cocaine, 40 mg cocaine). Physiological measures included vital signs, adverse events, and electrocardiogram. Subjective response was measured with visual analog scale (VAS) ratings of craving and drug effect. Cocaine pharmacokinetic parameters were calculated for each participant at each drug combination, using a non-compartmental model. MPH was well tolerated, did not have a clinically significant impact on cocaine's physiological effects, and decreased some of the positive subjective effects of cocaine. MPH did not significantly alter the pharmacokinetics of cocaine. The study results suggest that MPH at the doses studied can likely be used safely in an outpatient setting with active cocaine users.

The Michigan Experience with Safety and Effectiveness of Tranexamic Acid Use in Hip and Knee Arthroplasty.

BACKGROUND: The efficacy of tranexamic acid (TXA) in reducing blood loss and transfusion requirements in total hip and knee arthroplasty has been well established in small controlled clinical trials and meta-analyses. The purpose of the current study was to determine the risks and benefits of TXA use in routine orthopaedic surgical practice on the basis of data from a large, statewide arthroplasty registry. METHODS: From April 18, 2013, to September 30, 2014, there were 23,236 primary total knee arthroplasty cases and 11,489 primary total hip arthroplasty cases completed and registered in the Michigan Arthroplasty Registry Collaborative Quality Initiative (MARCQI). We evaluated the association between TXA use and hemoglobin drop, transfusion, length of stay (LOS), venous thromboembolism (VTE), readmission, and cardiovascular events by fitting mixed-effects generalized linear and mixed-effects Cox models. We used inverse probability of treatment weighting to enhance causal inference. RESULTS: For total hip arthroplasty, TXA use was associated with a smaller drop in hemoglobin (mean difference = -0.65 g/dL; 95% confidence interval [CI] = -0.60 to -0.71 g/dL), decreased odds of blood transfusion (odds ratio [OR] = 0.72; 95% CI = 0.60 to 0.86), and decreased readmissions (OR = 0.77; 95% CI = 0.64 to 0.93) compared with no TXA use. There was no effect on VTE (hazard ratio [HR] = 0.91; 95% CI = 0.62 to 1.33), LOS (incident rate ratio [IRR] = 1.00; 95% CI = 0.97 to 1.03), or cardiovascular events (OR = 0.85; 95% CI = 0.47 to 1.52). For total knee arthroplasty, TXA was associated with a smaller drop in hemoglobin (mean difference = -0.68 g/dL; 95% CI = -0.64 to -0.71 g/dL) and one-fourth the odds of blood transfusion (OR = 0.26; 95% CI = 0.21 to 0.31). There was an association with decreased risk of VTE within 90 days after surgery (HR = 0.56; 95% CI = 0.42 to 0.73), slightly decreased LOS (IRR = 0.93; 95% CI = 0.92 to 0.95), and no association with readmissions (OR = 0.90; 95% CI = 0.79 to 1.04) or cardiovascular events (OR = 1.12; 95% CI = 0.74 to 1.71). CONCLUSIONS: In routine orthopaedic surgery practice, TXA use was associated with decreased blood loss and transfusion risk for both total knee and total hip arthroplasty, without evidence of increased risk of complications. TXA use was also associated with reduced risk of readmission among total hip arthroplasty patients and reduced risk of VTE among total knee arthroplasty patients, and did not have an adverse effect on cardiovascular complications in either group. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

A medication screening trial evaluation of reserpine, gabapentin and lamotrigine pharmacotherapy of cocaine dependence.

AIMS: To conduct a preliminary evaluation of the safety and efficacy of reserpine, gabapentin or lamotrigine versus an unmatched placebo control as a treatment for cocaine dependence. DESIGN: A 10-week out-patient study using the Cocaine Rapid Efficacy and Safety Trial (CREST) study design. SETTING: The study was conducted at the Cincinnati Medication Development Research Unit (MDRU). PARTICIPANTS: Participants met Diagnostic and Statistical Manual version IV (DSM-IV) criteria for cocaine dependence. Sixty participants were enrolled, with 50 participants completing the final study measures. INTERVENTION: The targeted daily doses of medication were reserpine 0.5 mg, gabapentin 1800 mg and lamotrigine 150 mg. All participants received 1 hour of manualized individual cognitive behavioral therapy on a weekly basis. MEASUREMENTS: Primary outcome measures of efficacy included urine benzoylecgonine (BE) level, Cocaine Clinical Global Impression scale--observer and self-report of cocaine use. Safety measures included adverse events, electrocardiograms (ECGs), vital signs and laboratory tests. FINDINGS: Subjective measures of cocaine dependence indicated significant improvement for all study groups. Urine BE results indicated a significant improvement for the reserpine group (P < 0.05) and non-significant changes for the other study groups. No pattern of physical or laboratory abnormalities attributable to treatment with any of the medications was identified. There were three serious adverse events reported, none of which were related to study procedures. The medications appeared to be tolerated well. CONCLUSIONS: The present findings suggest that reserpine may be worthy of further study as a cocaine dependence treatment.

A placebo-controlled screening trial of tiagabine, sertraline and donepezil as cocaine dependence treatments.

AIMS: To conduct a preliminary evaluation of the safety and efficacy of tiagabine, sertraline or donepezil versus an unmatched placebo control as a treatment for cocaine dependence. DESIGN: A 10-week out-patient study was conducted using the Cocaine Rapid Efficacy and Safety Trial (CREST) study design. SETTING: This study was conducted at the Cincinnati Medication Development Research Unit (MDRU) and at an affiliated site in Dayton, Ohio. PARTICIPANTS: Participants met Diagnostic and Statistical Manual version IV (DSM-IV) criteria for cocaine dependence. Sixty-seven participants were enrolled with 55 completing final study measures. INTERVENTION: The targeted daily doses of medication were tiagabine 20 mg, sertraline 100 mg and donepezil 10 mg. All participants received 1 hour of manualized individual cognitive behavioral therapy on a weekly basis. MEASUREMENTS: Primary outcome measures of efficacy included urine benzoylecgonine (BE) level, Cocaine Clinical Global Impression Scale-Observer and self-report of cocaine use. Safety measures included adverse events, ECGs, vital signs and laboratory tests. FINDINGS: Subjective measures of cocaine dependence indicated significant improvement for all study groups. Generalized estimating equations analysis indicated that the tiagabine group showed a trend toward a significant decrease in urine BE level from baseline to weeks 5-8 (P = 0.10) and non-significant changes for the other study groups. No pattern of physical or laboratory abnormalities attributable to treatment with any of the medications was identified. There were three serious adverse events reported, none of which were related to study procedures. CONCLUSIONS: The present findings suggest that tiagabine may be worthy of further study as a cocaine dependence treatment.

You've got mail and need follow-up: the effect and patient perception of e-mail follow-up reminders after emergency department discharge.

OBJECTIVES: The hypothesis was that a reminder about recommended primary care physician (PCP) follow-up, sent via e-mail to patients discharged from the emergency department (ED), would increase the proportion of patients who followed up with their PCPs within the recommended time frame. Patient receptiveness to e-mail follow-up reminders was also assessed. METHODS: This was a mixed methods clinical intervention study with subjects randomized either to receive the usual care discharge instructions only or to also receive a reminder e-mail message the day after the ED visit. The reminder e-mail contained the subject's PCP's name and address and the recommended PCP follow-up time interval. A blinded review of outpatient PCP medical records was conducted to determine whether and when follow-up occurred. Researchers attempted to contact patients with a telephone survey 2 weeks after their ED visits. The primary outcomes between groups were compared using chi-square tests and relative risks (RRs) with 95% confidence intervals (CIs). RESULTS: Thirty-three percent of the intervention group and 32% of the control group followed-up as recommended (RR = 1.04, 95% CI = 0.81 to 1.33); 52% of the intervention group and 48% of the control group followed-up within 10 days of the recommended time (RR = 1.08, 95% CI = 0.91 to 1.29). The 334 patients (57%) successfully contacted via telephone demonstrated a high interest in receiving future e-mail reminders (75%), with the group that received e-mail reminders more likely to want one in the future than those who did not receive e-mail reminders (82.5% vs. 69.76%; p = 0.04). CONCLUSIONS: E-mail reminders sent after ED visits did not improve patients' adherence to the recommended timing of primary care follow-up contained in discharge instructions. Subjects in both the control and the intervention groups favorably viewed the concept of e-mail reminders, suggesting that the value of e-mail reminders after ED discharge may be in areas such as patient satisfaction that were not specifically targeted for measurement in this study.