Cardiovascular risk profile in individuals initiating treatment for overactive bladder - Challenges and learnings for comparative analysis using linked claims and electronic medical record databases.

For managing overactive bladder (OAB), mirabegron, a ß3 adrenergic receptor agonist, is typically used as second-line pharmacotherapy after antimuscarinics. Therefore, patients initiating treatment with mirabegron and antimuscarinics may differ, potentially impacting associated clinical outcomes. When using observational data to evaluate real-world safety and effectiveness of OAB treatments, residual bias due to unmeasured confounding and/or confounding by indication are important considerations. Falsification analysis, in which clinically irrelevant endpoints are tested as a reference, can be used to assess residual bias. The objective in this study was to compare baseline cardiovascular risk among OAB patients by treatment, and assess the presence of residual bias via falsification analysis of OAB patients treated with mirabegron or antimuscarinics, to determine whether clinically relevant comparisons across groups would be feasible. Linked electronic health record and claims data (Optum/Humedica) for OAB patients in the United States from 2011-2015 were available, with index defined as first date of OAB treatment during this period. Unadjusted characteristics were compared across groups at index and propensity-matching conducted. Falsification endpoints (hepatitis C, shingles, community-acquired pneumonia) were compared between groups using odds ratios (ORs) and 95% confidence intervals (CI). The study identified 10,311 antimuscarinic- and 408 mirabegron-treated patients. Mirabegron patients were predominantly older males, with more comorbidities. The analytic sample included 1,188 antimuscarinic patients propensity-matched to 396 mirabegron patients; after matching, no significant baseline differences remained. Estimates of falsification ORs were 0.7 (CI:0.3-1.7) for shingles, 1.5 (CI:0.3-8.2) for hepatitis C, 0.8 (CI:0.4-1.8) and 0.9 (CI:0.6-1.4) for pneumonia. While propensity matching successfully balanced observed covariates, wide CIs prevented definitive conclusions regarding residual bias. Accordingly, further observational comparisons by treatment group were not pursued. In real-world analysis, bias-detection methods could not confirm that differences in cardiovascular risk in patients receiving mirabegron versus antimuscarinics were fully adjusted for, precluding clinically relevant comparisons across treatment groups.

Meta-analysis of high- versus low-chloride content in perioperative and critical care fluid resuscitation.

BACKGROUND: The objective of this systematic review and meta-analysis was to assess the relationship between the chloride content of intravenous resuscitation fluids and patient outcomes in the perioperative or intensive care setting. METHODS: Systematic searches were performed of PubMed/MEDLINE, Embase and Cochrane Library (CENTRAL) databases in accordance with PRISMA guidelines. Randomized clinical trials, controlled clinical trials and observational studies were included if they compared outcomes in acutely ill or surgical patients receiving either high-chloride (ion concentration greater than 111 mmol/l up to and including 154 mmol/l) or lower-chloride (concentration 111 mmol/l or less) crystalloids for resuscitation. Endpoints examined were mortality, measures of kidney function, serum chloride, hyperchloraemia/metabolic acidosis, blood transfusion volume, mechanical ventilation time, and length of hospital and intensive care unit stay. Risk ratios (RRs), mean differences (MDs) or standardized mean differences (SMDs) and confidence intervals were calculated using fixed-effect modelling. RESULTS: The search identified 21 studies involving 6253 patients. High-chloride fluids did not affect mortality but were associated with a significantly higher risk of acute kidney injury (RR 1.64, 95 per cent c.i. 1.27 to 2.13; P < 0.001) and hyperchloraemia/metabolic acidosis (RR 2.87, 1.95 to 4.21; P < 0.001). High-chloride fluids were also associated with greater serum chloride (MD 3.70 (95 per cent c.i. 3.36 to 4.04) mmol/l; P < 0.001), blood transfusion volume (SMD 0.35, 0.07 to 0.63; P = 0.014) and mechanical ventilation time (SMD 0.15, 0.08 to 0.23; P < 0.001). Sensitivity analyses excluding heavily weighted studies resulted in non-statistically significant effects for acute kidney injury and mechanical ventilation time. CONCLUSION: A weak but significant association between higher chloride content fluids and unfavourable outcomes was found, but mortality was unaffected by chloride content.

Severe intimate partner violence and alcohol use among female trauma patients.

BACKGROUND: The lifetime prevalence of intimate partner violence (IPV) among women in the United States is reported to be between 18 and 50%. One-third of female homicide victims are killed by an intimate partner and alcohol is often involved. Despite these figures, 77% of women have never been screened for IPV. Substance abuse in male partners is known to place women at risk. We examined the role of female alcohol use on rates of severe IPV. Our hypotheses were: (1) the prevalence of IPV among women seen in trauma centers is greater than that found in national surveys; (2) alcohol problems among abused women and their partners are greater than those among non-abused women; (3) females and their partners alcohol problems are each independently associated with IPV; and (4) female trauma center patients support domestic violence screening. METHODS: An in-person survey was administered to 95 consecutive adult female trauma patients admitted to a Level I Trauma Center. The survey included questions about past-year and lifetime severe IPV, female and male partner alcohol use, and willingness to participate in IPV screening and referral. The multivariate associations of female and partner alcohol use with past-year severe IPV were assessed with logistic regression. RESULTS: Nearly one-half (46.3%) of women reported a lifetime history of severe IPV, with 26% experiencing severe IPV in the past year. Past-year IPV was identified in 59.1% of women screening positive for drinking problems, but in only 12.7% of those screening negative for drinking problems (p = 0.001). Similarly, past-year IPV prevalence was 55.2% when the partner was a problem drinker versus 8.3% when he was not (p = 0.001). Multivariate analysis showed that female problem drinking (odds ratio [OR] = 5.8) and partner problem drinking (OR=8.9) were independent predictors of past-year severe IPV. The majority of women (90.5%) felt that it was appropriate for health care professionals to screen for IPV; 90% of women with a history of IPV thought screening was important and 71% wished a previous healthcare provider had asked them about it. CONCLUSIONS: Female trauma patients demonstrate a higher prevalence of severe IPV than the general population. IPV rates appear to be related to both female and partner alcohol misuse. Female trauma patients endorsed IPV screening and thus should be screened for alcohol use and IPV in a way that minimizes future violence risk. Further research is needed to elucidate whether intervention for alcohol misuse has an impact on rates of IPV in this population.

Intoxicated motor vehicle passengers: an overlooked at-risk population.

HYPOTHESES: Intoxicated motor vehicle passengers are similar to intoxicated drivers in recurrent health care encounters and risk of death for 5 years after injury. Intoxicated passengers have a greater risk of death than population controls. DESIGN: Historical cohort study. SETTING: University-based level I trauma center. PARTICIPANTS: Motor vehicle crash victims admitted to a level I trauma center in 1993. MAIN OUTCOME MEASURES: Recurrent hospitalization, emergency department visits, survival analysis, and standardized mortality ratios for 5 years following injury. RESULTS: More than one quarter of intoxicated passengers and drivers had recurrent hospitalizations and emergency department visits. Intoxicated occupants were more likely to return to the hospital and the emergency department than nonintoxicated controls (odds ratios, 2.0 and 2.7, respectively). Intoxicated passengers were at increased risk of dying compared with nonintoxicated occupants (P = .008) and with the general population (standardized mortality ratio = 5.8). Intoxicated occupants were more likely to die an alcohol-related death (P< .001). CONCLUSIONS: Intoxicated passengers injured in a motor vehicle crash are similar to intoxicated drivers in recurrent hospitalizations and emergency department visits. Intoxicated passengers have an increased mortality rate in the 5 years following injury.

Intoxicated motor vehicle passengers warrant screening and treatment similar to intoxicated drivers.

BACKGROUND: Alcohol interventions decrease alcohol consumption and recurrent injury. The study hypotheses are (1) intoxicated passengers are similar to intoxicated drivers in crashes and driving under the influence of alcohol (DUI), and (2) DUI conviction rates after injury are low. METHODS: Intoxicated motor vehicle occupants hospitalized for injury in 1996-1998 were matched to the state traffic database for crashes and DUI. Drivers and passengers were compared for crashes and DUI in the 2 years preceding and 1 year after admission. Driver DUI citation at the time of admission was also recorded. A logistic regression model for crash and DUI probability was constructed. RESULTS: Six hundred seventy-four patients met inclusion criteria. In the 2 years preceding admission, passengers and drivers were equally cited for crashes (14.7% vs 19.3%, p = 0.12). In 1 year after admission, they were also equally cited (7.1% vs 7.7%, p = 0.92). Driver/passenger status was not a predictor by logistic regression; 13.4% of intoxicated drivers were convicted of DUI for the admitting crash. CONCLUSION: Intoxicated passengers and drivers are equally likely to be cited for crashes and DUI before and after admission for injury. Few admitted intoxicated drivers are convicted of DUI. Screening and intervention for all intoxicated crash occupants is warranted.

Evaluation of cervical spine in intensive care patients following blunt trauma.

The aim of this study was to review a Level 1 trauma center's use of early (< 72 hours from injury) limited MRI to "clear" cervical spine extradural soft tissue injuries in ICU patients sustaining blunt trauma. A retrospective review of the records of patients meeting entry criteria during 1997 was performed. Demographic data, cervical spine radiographic and imaging evaluation, results, and follow-up information were gathered. One hundred and fifty patients met criteria. Forty-one patients had initial static radiographs that revealed cervical spine trauma. Twenty-seven of the 108 patients with normal initial static radiographs had evidence of extradural soft tissue injury on MRI indicating potential spinal column instability. Twenty-one of the 108 patients had negative MRI and were liberated from cervical spine precautions at a mean of 2.9 +/- 0.9 days from injury. The remaining patients were cleared of cervical spine precautions by plain radiographs and reliable clinical examinations, or by dynamic radiographs, or they died before complete evaluation. The diagnosis of acute injury to the cervical spine from blunt trauma in ICU patients must include evaluation of the osseous spine and extradural soft tissues. Dynamic studies such as flexion and extension views place the obtunded ICU patient at risk of potential neurologic injury. MRI is a noninvasive imaging technique that allows evaluation of extradural soft tissue injury with potentially less patient risk and with fewer personnel. MRI allows early liberation of cervical spine precautions in those patients with negative studies. Further studies are needed to compare specific ligamentous injury patterns by MRI with dynamic studies of the C-spine to further define MRI injury patterns indicating risk of acute spinal instability.

Rare complications of endoscopic retrograde cholangiopancreatography: two case reports.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is a diagnostic procedure with several known risks. We present two rarely reported complications of ERCP and sphincterotomy: transverse mesocolon disruption with ischemic colitis and splenic rupture. RESULTS: The first patient, a 54-year-old female, presented one day following ERCP and stent revision for pancreas divisum. She presented with hypotension and abdominal distention. An abdominal computed tomography (CT) showed a ruptured spleen, which was confirmed on laparotomy. She had a complicated postoperative course and died of multiple organ failure. The second patient is a 56-year-old female who presented five days after ERCP and sphincterotomy with abdominal pain, abdominal wall ecchymosis, and decreasing hematocrit. Her evaluation included hospital admission and abdominal CT scan, which showed free fluid and a large hematoma in the transverse mesocolon. These findings were confirmed on laparotomy and a devascularized segment of bowel was resected. CONCLUSION: Only 6 cases of ERCP-related splenic injury have been reported in the literature. One additional report is available of a fatal splenic artery injury. No previous reports exist of a mesenteric hematoma resulting in bowel devascularization. Prompt evaluation and awareness of potential complications should help capture potentially life-threatening sequelae of ERCP.

Retrospective study of neostigmine for the treatment of acute colonic pseudo-obstruction.

Acute colonic pseudo-obstruction (ACPO) typically develops postoperatively or after severe illness. Studies suggest that pharmacologic manipulation with intravenous (i.v.) neostigmine (NSM) may be an effective and less invasive treatment modality for ACPO with minimal side effects. The purpose of this study was to retrospectively assess the efficacy and incidence of complications of an i.v. NSM bolus in patients with ACPO. Eight patients with ten episodes of ACPO were treated with a bolus dose of NSM. Rapid and effective decompression of the colon was achieved in six episodes after a single dose of NSM at a mean of 22.8 +/- 13.5 minutes. In three episodes decompression occurred after a second dose of NSM at a mean of 44.7 +/- 37.7 minutes. One patient failed NSM treatment but responded to a Cystografin enema. One patient experienced significant bradycardia. NSM is a simple, safe, and effective treatment for ACPO and based on result comparison of this study and previous studies both bolus and slow infusion dosing practices of NSM are effective. The NSM bolus dosing side effect profile has been shown to include significant bradycardia, whereas when NSM was infused over one hour significant bradycardic episodes requiring treatment have not been encountered. We propose that a prospective study evaluating NSM dosing as an i.v. bolus versus an i.v. infusion would be useful in determining whether NSM infusion can be proven safer than bolus dosing for the treatment of ACPO.

Predictors of outcome in trauma during pregnancy: identification of patients who can be monitored for less than 6 hours.

BACKGROUND: The first objective of this study was to identify risk factors in pregnant patients suffering blunt trauma predictive for uterine contractions, preterm labor, or fetal loss. The second objective was to identify patients who can safely undergo fetal monitoring for 6 hours or less after blunt trauma by selecting out those patients demonstrating the identified risk factors. METHODS: A retrospective chart review was performed from January 1, 1990, through December 31, 1998. Charts were reviewed for numerous possible risk factors for adverse outcomes. Statistical analysis was performed by using logistic regression. RESULTS: A total of 271 pregnant patients admitted after blunt trauma were identified. Risk factors significantly predictive of fetal death included ejections, motorcycle and pedestrian collisions, maternal death, maternal tachycardia, abnormal fetal heart rate, lack of restraints, and Injury Severity Score > 9. Risk factors significantly predictive of contractions or preterm labor included gestational age >35 weeks, assaults, and pedestrian collisions. CONCLUSION: Pregnant patients who present after blunt trauma with any of the identified risk factors for contractions, preterm labor, or fetal loss should be monitored for at least 24 hours. Patients without these risk factors can safely be monitored for 6 hours after trauma before discharge.

The consequences of suppression of anaerobic bacteria.

Anaerobic bacteria such as Bacteroides fragilis, Peptostreptococcus species, and Fusobacterium species, when accompanied by aerobic bacteria or in the presence of dead tissue, can cause severe infections. This article discusses the most common type of anaerobic infection, i.e., infection after colonic contamination of the abdominal cavity and soft tissues. Colonic anaerobes rarely cause infections as solitary pathogens. Mixed infections of aerobes and anaerobes are treated by source control, surgical drainage and debridement, and combination antibiotic therapy. Antimicrobial treatment should cover both anaerobes and aerobes; treatment of mixed infections with anti-anaerobic agents alone is likely to result in abscess formation. Recent trends toward cost cutting and the advent of antibiotics with good coverage of both aerobes and relevant pathogenic anaerobes have led to increased single-agent therapy with cefoxitin, cefotetan, ampicillin/sulbactam, imipenem/cilastatin, ticarcillin/clavulanate, trovafloxacin/alatrofloxacin, and piperacillin/tazobactam. In the past 15 years, research has begun to focus on the gut barrier, particularly on the beneficial effects of anaerobic microflora. Directing antibiotic therapy against the anaerobe when it is involved in clinical infection is important; however, the negative consequences of anti-anaerobic antibiotic therapy on the beneficial effects of normal distal gut colonization must also be considered.

Methamphetamine use in trauma patients: a population-based study.

BACKGROUND: There are indications that methamphetamine production and illicit use are increasing. We investigated the epidemiology of methamphetamine use in trauma patients in an area of heavy methamphetamine prevalence. STUDY DESIGN: This was a retrospective population-based review. We reviewed toxicology and alcohol test results in trauma patients admitted to the University of California, Davis, between 1989 and 1994 to the only trauma center serving a population of 1.1 million. RESULTS: Positive methamphetamine rates nearly doubled between 1989 (7.4%) and 1994 (13.4%), compared with a minimal increase in cocaine rates (5.8% to 6.2%) and a decrease in blood alcohol rates (43% to 35%). Methamphetamine-positive patients were most likely to be Caucasian or Hispanic; cocaine-positive patients were most likely to be African American. Methamphetamine-positive patients were most commonly injured in motor vehicle collisions or motorcycle collisions; cocaine-positive patients were most commonly injured by assaults, gunshot wounds, or stab wounds. Cocaine positivity and alcohol positivity predicted a decreased need for emergency surgery and cocaine positivity predicted a decreased need for admission to the ICU. CONCLUSIONS: Methamphetamine use in trauma patients increased markedly in our region between 1989 and 1994, alcohol rates decreased, and cocaine rates remained unchanged. Methamphetamine-positive patients had mechanisms of injury similar to those of alcohol-positive patients, so injury prevention strategies for methamphetamine should be patterned after strategies designed for alcohol.

Ogilvie's syndrome in the surgical patient: a new therapeutic modality.

Acute colonic pseudo-obstruction, Ogilvie's syndrome, most often appears as a complication of other clinical conditions. It is characterized by massive colonic dilation in the absence of a mechanical cause. Therapy for this condition has traditionally been colonoscopic decompression via a flexible colonoscope. We performed a retrospective study to assess the efficacy of Cystografin enema for colonic decompression in Ogilvie's syndrome. We present a series of 18 patients who developed Ogilvie's syndrome while hospitalized for trauma (n = 10), burn (n = 1), gastrointestinal surgery (n = 4), and hip replacement (n = 3). The mean pre-enema cecal size was 13 cm (range 10 to 15 cm). The mean postenema cecal size was 8.5 cm (range 6 to 15 cm). Fifteen of the 18 patients underwent Cystografin enema as the primary mode of decompression. Three had undergone prior colonoscopy, which had failed. One of the 18 patients required repeat enema for inadequate decompression after the first enema and one underwent colonoscopy for recurrence. Two patients underwent operative intervention after the enema. There were no complications related to the enema. In all patients we were able to rule out a mechanical cause of large bowel obstruction. We believe the safety, efficacy, and ease of this procedure make Cystografin enema optimal first-line treatment for acute colonic pseudo-obstruction.

Stab wounds to the back/flank in hemodynamically stable patients: evaluation using triple-contrast computed tomography.

Triple-contrast computerized tomography (3CT) has been proposed as a method to detect high-risk injuries in hemodynamically stable patients with stab wounds (SWs) to the back/flank and to successfully triage patients with low-risk scans into a potentially cost-effective treatment algorithm. The purpose of this study was to retrospectively review our experience with the use of 3CT for diagnostic accuracy of SWs to the back/flank and to evaluate potential decreased length of stay (LOS) in the hospital for patients with low-risk scans and no associated injuries. Seventy-nine hemodynamically stable patients met criteria for inclusion in this review. Fifty-eight 3CTs were performed for initial evaluation, 44 low risk and 14 high risk, and 21 patients underwent mandatory laparotomy. The accuracy of 3CT was found to be 97.9 per cent. The LOS was significantly less in patients who had no associated injuries and a low-risk 3CT (16.5 hours), as compared with all other treatment groups. Hemodynamically stable patients with SWs to the back/flank may be safely triaged using 3CT. Patients with low-risk scans and no associated injuries may be discharged immediately, and those with potential delayed associated injuries should be observed for 6 to 24 hours. This strategy significantly decreases LOS in patients with low incidence of significant injury.

A prospective evaluation of video-assisted thoracic surgery for persistent air leak due to trauma.

BACKGROUND: The time required for air leak resolution after chest trauma is not well described. Based on an institutional review of posttraumatic air leaks our hypothesis was that video-assisted thoracic surgery (VATS) for persistent posttraumatic air leak would decrease chest tube days and length of stay compared with nonoperative management. METHODS: Patients were offered VATS versus nonoperative management when air leaks persisted longer than 3 days and the patients were otherwise ready for discharge. Chest tube days and length of stay were recorded. RESULTS: Of 223 trauma patients requiring chest tubes, 50 had persistent air leaks, 39 of whom were otherwise ready for discharge. Twenty-five chose VATS and 14 nonoperative (NOP) treatment. The mean chest tube days was 8.1 for VATS versus 11.8 for NOP (P = 0.001). Mean length of stay was 9.7 days for VATS and 16.5 days for NOP (P = 0.002). CONCLUSIONS: In patients otherwise ready for discharge VATS reduces chest tube days and length of stay when used to treat persistent posttraumatic air leak.

In-house versus on-call attending trauma surgeons at comparable level I trauma centers: a prospective study.

BACKGROUND: The purpose of this study was to prospectively compare patient outcomes based on the presence of in-house versus on-call attending trauma surgeons at comparable Level I trauma centers. METHODS: Two designated Level I trauma centers agreed to prospectively review trauma admissions over a 6-month period, one institution with 24-hour in-house trauma attending surgeons (IH), and the other with trauma-attending surgeons taking call from home (OC) available to the hospital within 15 minutes of notification. A 6-month prospective study was conducted reviewing all trauma patients admitted to both trauma centers with an Injury Severity Score > or =16. Comparisons were made between institutions utilizing admission demographics, clinical presentation, times to clinical care, and mortality rates. RESULTS: In comparison, OC and IH institutions were distinctly different in geographic environment, size, and number of patients admitted. As a group, IH patients were significantly older, with higher Injury Severity Scores and lower Glasgow Coma Scale scores than the OC group. In all comparisons, OC trauma attending surgeons responded to the trauma room with equal speed or more rapidly when compared with IH trauma attending surgeons. There were no other significant differences in either population in times to provision of clinical care or in clinical outcome. CONCLUSION: The ability of the OC institution to be similar to the IH institution in its provision of clinical care and mortality rate is accomplished in an environment where trauma attending surgeons live within a 15-minute response time to the trauma center. Using a voice-paged trauma alert activation with accurate information and sufficient warning, evaluation, provision of care, and clinical outcome of the acutely injured patient can be provided equally by in-house trauma attending surgeons and trauma attending surgeons on-call from home.