Long-term follow-up of branch-duct intraductal papillary mucinous neoplasms with No change in first 5 Years of diagnosis.

BACKGROUND: Discontinuation of branch-duct intraductal papillary mucinous neoplasm (BD-IPMN) surveillance after 5 years of no change remains controversial. Long-term outcomes of BD-IPMN without significant changes in the first 5 years were evaluated. METHODS: We performed a multi-center retrospective analysis of patients with BD-IPMN diagnosis from 2005 to 2011 (follow-up until 2017). Significant changes were defined as pancreatic cancer (PC), pancreatectomy, high-risk stigmata (HRS), worrisome features (WF) and worrisome EUS features (WEUS). RESULTS: Of 982 patients who had no significant changes, 5 (0.5%), 7 (0.7%), 99 (10.1%), 4 (0.4%) patients developed PC, HRS, WF, WEUS, respectively, post-5 years. PC and HRS/WF/WEUS incidences at 12 years were 1.0% and 29.0%, respectively. Patients that developed HRS/WF/WEUS had larger cyst size in first 5 years compared to those that did not [16 (12-23) vs. 12 (9-17) mm, p = 0.0001], cyst size of >15 mm having higher cumulative incidence of HRS/WF/WEUS. PC mortality was 0.8%; all-cause mortality was 32%. Incidence of mortality due to PC was higher in HRS/WF/WEUS group, p < 0.0001. The mortality rate at 12 years for ACCI (age-adjusted Charlson Comorbidity Index) of ≤3, 4-6, and ≥7 were 3.5%, 19.9%, and 57.6% (p < 0.0001), respectively. CONCLUSIONS: Incidence of PC in patients with BD-IPMN without significant changes in first 5 years of diagnosis remains low at 1.0%. Incidence of HRS/WF/WEUS was higher at 29.0%. PC-related mortality was higher in HRS/WF/WEUS group. These risks should be weighed against patients' overall mortality (utilizing scoring systems such as ACCI) when making surveillance decision of BD-IPMN beyond 5 years.

Home based cardiac rehabilitation: A retrospective cohort analysis on all-cause mortality and hospital readmission rates across sexes and races.

Objective: Studies have shown that both home-based cardiac rehabilitation (HBCR) and center-based cardiac rehabilitation (CBCR) exhibit comparable efficacy in reducing mortality during short-term follow-up periods of up to 12 months. However, research on sex- and race-specific outcomes associated with HBCR is limited. This study examines all-cause mortality and hospital readmission among patients referred to HBCR, with stratification by sex and race. Methods: This Kaiser Permanente Southern California (KPSC) retrospective cohort study followed 6,868 patients from HBCR referral until death, disenrollment, or December 31, 2021. There were 3,835 HBCR graduates, 722 non-graduates, and 2,311 non-enrolled patients. Cox models were used to estimate hazard ratios (HR) and 95 % confidence intervals (CI) comparing 1) HBCR graduates vs. non-enrolled, and 2) HBCR graduates vs. non-graduates, stratified by sex and race. Differential outcomes among strata were analyzed using Kaplan-Meier curves. Results: Among the 6,868 patients referred to HBCR, 4693 (68.3 %) were male, 2,175 (31.7 %) female, 870 (12.7 %) Asian/Pacific Islander, 731 (10.6 %) African American, 1,612 (23.6 %) Hispanic/Latino, and 3,646 non-Hispanic White (53.1 %). Over a mean follow-up period of 2.28 years, HBCR graduates, compared to patients who did not enroll in HBCR, had overall significantly lower risks of all-cause mortality and hospitalization. These results remained significant with stratification by sex and race. Compared to HBCR non-graduates, HBCR graduates overall had significantly lower risks of all-cause mortality and hospitalization. In the same comparison, mortality risk was significantly reduced for male and White patients; risk of hospital readmission was significantly reduced in both sexes, African American, and White patients. Among HBCR graduates, no significant differences in all-cause mortality or hospital readmission were observed across sexes and races. Conclusion: HBCR participation is associated with reduction of all-cause mortality and hospital readmission rates across sexes and races. Notably, we observed benefits at varying levels of engagement, which suggests that even partial completion of HBCR is associated with risk reduction. Among HBCR graduates, we found similar outcomes across sexes and races, which suggests that the program can be effective among diverse patient groups.

Patients With Graft Tears Leaving the Tuberosity Covered Have Similar Functional Outcomes to Those With an Intact Graft After Superior Capsular Reconstruction.

BACKGROUND: Studies to date of superior capsular reconstruction (SCR) comparing outcomes of healed grafts versus torn grafts do not separate graft tears based on location of the tear, rather they combine and report all tears as a single group. PURPOSE/HYPOTHESIS: The purpose of this study was to correlate functional outcome with graft integrity and graft tear location after SCR with a dermal allograft. It was hypothesized that the functional outcomes of patients with an intact graft would be equivalent to those with graft tears leaving the tuberosity covered. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: Patients who underwent SCR with an acellular dermal allograft at a single institution were included. Pre- and postoperative American Shoulder and Elbow Surgeons (ASES), Oxford Shoulder Score, visual analog scale (VAS) for pain, and postoperative Single Assessment Numeric Evaluation (SANE) scores were recorded. A magnetic resonance imaging scan was performed postoperatively to assess graft integrity. RESULTS: A total of 39 patients met inclusion criteria. Mean age of patients was 60.4 ± 8.7 years; mean follow-up was 53.3 ± 25 months (range, 14-98 months). Magnetic resonance imaging performed at a mean of 17.5 months (range, 6-66 months) demonstrated an intact graft in 14 (36%); tear from the glenoid in 11 (28%), from midsubstance in 4 (10%), and from the tuberosity in 8 (21%); and complete graft absence in 2 (5%). Patients were divided into group 1 (intact graft), group 2 (tuberosity covered: tears from glenoid and midsubstance tears), and group 3 (tuberosity bare: tears from the tuberosity and dissolved or absent grafts). In group 1, there was significant improvement in ASES (37.9 to 88.5; P < .001), Oxford (25.2 to 46.2; P < .001), and VAS (6.8 to 0.9; P < .001). In group 2, there was significant improvement in ASES (32.2 to 86.1; P < .001), Oxford (23.4 to 44.2; P < .001), and VAS (7.3 to 1.3; P < .001). In group 3, there was no significant improvement in ASES (40.3 to 45.8; P = .50) or Oxford (33.5 to 31.4; P = .81), but there was a significant reduction in VAS (7.1 to 5.4; P = .03). There was no significant difference between group 1 and 2 in postoperative ASES (88.5 vs 86.1; P = .59), Oxford (46.2 vs 44.2; P = .07), VAS (0.9 vs 1.3, P = .42) and SANE (85.4 vs 83.2; P = .92) scores. However, group 3 had significantly lower ASES (45.8; P < .001), lower Oxford (31.4; P < .001), lower SANE (45.4; P < .001), and higher VAS (5.4; P < .001) scores than groups 1 and 2. There were no differences in outcomes based on sex (P = .72), previous surgery (P = .06), preoperative acromiohumeral distance (P = .57), and preoperative Goutallier stage of the supraspinatus (P = .16). CONCLUSION: Patients who underwent SCR with a dermal allograft and developed a graft tear leaving the tuberosity covered had equivalent functional outcomes to those with an intact graft.

The role of implantable cardioverter defibrillators in high-risk CABG patients identified early post-cardiac surgery.

AIMS: To assess clinical markers that can be used in predicting the outcome and role of implantable cardioverter defibrillators (ICD) in coronary artery bypass surgery (CABG) patients with severely depressed left ventricular ejection fraction (LVEF), independent of time from revascularization. METHODS AND RESULTS: The database was searched for patients who had CABG surgery and had an ICD within 4 months of surgery, between 1999 and 2005. The records were reviewed for LVEF, status of revascularization, programmed electrical stimulation results, and medications. The primary endpoints were: combined total mortality (TM) and appropriate ICD therapy (ICD-T), and the individual outcomes of TM and ICD-T. One hundred and sixty-four patients were identified, 69 had an ICD implanted for primary prevention of sudden cardiac death and were followed till June 2009. The mean pre- and post-operative LVEFs were 29 and 33%, 46 (67%) had incomplete revascularization, and 38 (55%) had inducible ventricular arrhythmias. Over the mean follow-up of 40 months, 20 patients (29%) died and 18 (26%) had ICD-T. In the Cox proportional hazard model, the following variables were significant at the 0.05 level; for the combined outcome TM and ICD-T: congestive heart failure (CHF) class III/IV and coronary artery disease (CAD) + valvular disease; for ICD-T outcome: CAD + valvular disease; for TM outcome: female gender, LVEF < 35%, CHF class III/IV, and lack of angiotensin converting enzyme-inhibitor therapy. CONCLUSION: Clinical assessment of CABG patients can assist in selecting a high-risk group with TM and ICD-T rates comparable to those of primary prevention studies and could be useful for future randomized ICD studies in this selective group of patients.

Diseases and drugs that increase risk of acute large bowel ischemia.

BACKGROUND & AIMS: Information is limited on risk factors for acute large bowel ischemia (ALBI). We investigated diseases and drugs associated with ALBI. METHODS: We compared patients hospitalized with ALBI and controls through multivariate analysis of prior outpatient/emergency department/inpatient diagnoses and pharmacy dispensing records. RESULTS: There were 379 cases and 1516 controls (median age, 69 y; range, 25-97 y; 74.4% female). Disorders that were diagnosed in more cases than controls, based on univariate analysis (P < .05), included hypertension, diabetes, chronic obstructive pulmonary disease, atrial fibrillation, congestive heart failure, depression, asthma, coronary artery disease, dementia, rheumatoid arthritis, irritable bowel syndrome, dialysis dependency, diarrhea, and constipation. Drugs dispensed to more cases than controls were antihypertensives, opioids, statins, female hormones, potentially constipating drugs, histamine H(2)-antagonists, immunomodulators, digoxin, clopidogrel/ticlopidine, taxanes/vinca alkaloids, and antibiotics. In all cases, ALBI was associated independently with hypertension (adjusted odds ratio [AOR], 3.21, 95% confidence interval [CI]; 2.28-4.53; P < .0001), chronic obstructive pulmonary disease (AOR, 3.13; 95% CI, 2.06-4.75; P < .0001), diarrhea (AOR, 2.36; 95% CI, 1.13-4.89; P = .0218), atrial fibrillation (AOR, 2.21; 95% CI, 1.34-3.64; P = .0019), congestive heart failure (AOR, 1.94; 95% CI, 1.11-3.39; P = .0205), diabetes (AOR, 1.82; 95% CI, 1.31-2.53; P = .0004), antibiotics (AOR, 3.30; 95% CI, 2.19-4.96; P < .0001), opioids (AOR, 1.96; 95% CI, 1.43-2.67; P < .0001), and potentially constipating drugs (AOR, 1.75; 95% CI, 1.25-2.44; P = .0012). Analysis of only women revealed similar associations except for diarrhea plus rheumatoid arthritis (AOR, 3.27; 95% CI, 1.07-9.96; P = .0370), irritable bowel syndrome (AOR, 2.72; 95% CI, 1.04-7.14; P = .0424), and female hormones (AOR, 1.88; 95% CI, 1.30-2.73; P = .0009). CONCLUSIONS: Heterogeneous diseases and drugs increase the risk of ALBI, consistent with multifactorial pathogenesis.

Epidemiology, clinical features, high-risk factors, and outcome of acute large bowel ischemia.

BACKGROUND & AIMS: Only a limited amount of important information is available on acute lower bowel ischemia (ALBI). We investigated the epidemiology, clinical aspects, high-risk factors, and outcome of ALBI. METHODS: We retrospectively analyzed data collected from 401 patients with 424 hospitalizations with ALBI in a prepaid health system for 7 years. RESULTS: The estimated annual incidence of ALBI was 15.6/100,000 patient-years (22.6 female, 8.0 male), with a marked age-related increase. ALBI preceded 400 admissions (94%) and followed surgery or medical admission of 24 patients (6%); 307 (72%) had rectal bleeding and abdominal pain. In 417 episodes, left-sided or transverse (368, 88%) exceeded right-sided or bilateral ALBI (49, 12%). Thirty-one patients (8%) had resection; 15 died (4%). Factors that were independently associated with resection and/or death included right-sided or bilateral distribution (adjusted odds ratio [AOR], 14.64; 95% confidence interval [CI], 4.82-44.50; P < .001), onset after admission (AOR, 7.48; 95% CI, 2.19-25.54; P < .005), hypotension (AOR, 4.45; 95% CI, 1.18-16.76; P < .05), tachycardia (AOR, 4.40; 95% CI, 1.46-13.26; P < .01), warfarin use (AOR, 4.33; 95% CI, 1.21-15.47; P < .05), antibiotic therapy (AOR, 3.94; 95% CI, 1.23-12.64; P < .05), male sex (AOR, 2.65; 95% CI, 1.00-7.05; P = .05), nonsteroidal anti-inflammatory drug use (AOR, 0.15; 95% CI, 0.04-0.53; P < .005), and rectal bleeding (AOR, 0.24; 95% CI, 0.09-0.65; P < .005). During a mean of 2.6 +/- 1.9 years, no patient developed chronic colitis, and 1 (<1%) had stricture dilation. Estimated ALBI recurrence was 3%, 5%, 6%, and 10% at years 1, 2/3, 4, and 5/6, respectively. CONCLUSIONS: ALBI is common and agerelated and predominates in female patients. Demographic and clinical variables predict severe ALBI. Chronic sequelae are rare. Recurrence is substantial.

Fatal Asthma: An Audit of 30 Million Patient-Years of Health Plan Membership from 2007 to 2015.

BACKGROUND: Without accurate data on deaths directly caused by asthma, prevention will be difficult. OBJECTIVE: To determine how often asthma could be confirmed as a proximal cause of death in a large well-defined population with active health plan membership and no acute barriers to medical care. METHODS: All deaths occurring in active Kaiser Permanente Southern California health plan members between 2007 and 2015 were identified. Asthma-coded deaths were manually audited for cause. Health care and asthma medication use in the 6 months before death were determined. RESULTS: There were 248 (0.80 per 100,000 patient-years) unaudited asthma-coded deaths. There were only 63 (26.5%) (0.20 per 100,000 patient-years) asthma-confirmed deaths. Individuals with asthma-confirmed deaths were younger, less likely to have ever smoked, and had fewer emergency visits in the 6 months before death compared with those with asthma excluded. Individuals with asthma-confirmed deaths used preventative inhalers at very low rates. We unexpectedly found that ever inclusion in the 2016 National Committee for Quality Assurance health effectiveness data and information set (HEDIS) for persistent asthma was associated with a higher risk of all-cause early death. Individuals with asthma-confirmed deaths were also unlikely to be in the HEDIS asthma dataset in the year they died, thus not targeted for outreach. CONCLUSIONS: Audit-confirmed fatal asthma is more likely to occur in younger, nonsmoking, individuals, using very low rates of preventive inhalers. This will be a very difficult group to prospectively identify and manage effectively. Further research into the reasons for early death after HEDIS asthma dataset inclusion is warranted.

Racial/Ethnic differences in ischemic stroke rates and the efficacy of warfarin among patients with atrial fibrillation.

BACKGROUND AND PURPOSE: Warfarin reduces stroke risk in studies of predominantly white patients with atrial fibrillation (AF). Whether nonwhites also have lower rates of stroke while treated with warfarin is unclear. METHODS: A multiethnic stroke-free cohort hospitalized with nonrheumatic AF was identified in a large health maintenance organization. Stroke risk factors (advanced age, diabetes, hypertension, and heart failure), warfarin use, and anticoagulation intensity were assessed. Crude ischemic stroke rates were calculated by Poisson regression for each group while using and not using warfarin. Cox proportional hazard models were constructed to assess the independent effect of race/ethnicity on ischemic stroke. RESULTS: Between 1995 and 2000, we identified 18867 AF hospitalizations (78.5% white, 8% black, 9.5% Hispanic, and 3.9% Asian). Over the course of 63204 person-years follow-up (median, 3.3 years), 1226 ischemic strokes were identified. The percent-time on warfarin did not differ by race/ethnicity. The median percent-time on warfarin that international normalized ratio was 2 to 3 was 54.5% overall, but it was lower in blacks at 47.8%, whereas the other groups had a rate of approximately 54%. The rate ratios (95% CI) of ischemic stroke with warfarin compared to without warfarin for whites, blacks, Hispanics, and Asians were 0.79 (0.68 to 0.90), 0.92 (0.65 to 1.30), 0.71 (0.48 to 1.05), and 0.65 (0.34 to 1.23), respectively. CONCLUSIONS: In this cohort, we did not observe a statistically significant lower rate of stroke with warfarin therapy among nonwhites (in particular blacks) with previous AF hospitalizations. The relatively small numbers of nonwhites renders our estimates less than precise and should be interpreted with caution.

Effect of race/ethnicity on the efficacy of warfarin: potential implications for prevention of stroke in patients with atrial fibrillation.

Atrial fibrillation (AF) is the most common sustained arrhythmia seen in clinical practice. It affects approximately 6% of persons over 65 years of age and is independently associated with a 4- to 5-fold higher risk of ischaemic stroke and a 2-fold higher risk of death. Randomized controlled trials have shown that treatment with adjusted-dose oral vitamin K antagonists (primarily warfarin with a target international normalized ratio [INR] of 2.0-3.0) reduces the relative risk of ischaemic stroke by two-thirds (an approximately 3% reduction in annual absolute risk), but is associated with a 0.2% excess annual absolute risk of intracranial haemorrhage (ICH). However, in 'real world' studies, the risk reductions in ischaemic stroke with warfarin have been significantly lower (25-50% relative risk reduction) than in selected trial samples. Moreover, more than 90% of patients enrolled in the sentinel trials were White/European. This raises the question of whether the beneficial results of warfarin can be extrapolated to persons of colour. Important differences in stroke risk profile and responsiveness to warfarin exist across racial/ethnic groups, such that one cannot assume a priori that there is a net benefit of warfarin therapy for AF patients of all racial/ethnic groups.Among patients with ischaemic stroke, AF is more likely to be implicated as the cause of stroke in the White population than in other racial/ethnic groups. Furthermore, AF may be a stronger predictor of ischaemic stroke among the White population than in Black or Hispanic/Latino populations. Approximately one-third of strokes in AF patients are noncardioembolic. Warfarin has been shown to be ineffective in preventing recurrent noncardioembolic strokes. Many persons of colour with AF have other risk factors that predispose them to noncardioembolic stroke, which may partially explain why warfarin has been reported to be less efficacious in preventing strokes in non-White patients with AF, even after adjustment for co-morbidities and anticoagulation monitoring. Notably, the background incidence of ICH is higher in Black, Hispanic and Asian patients than in White patients. Any greater than expected increases in bleeding secondary to anticoagulation may potentially offset any benefit gained from cardioembolic stroke reduction, although this has not been fully resolved.Finally, there are racial/ethnic differences in the prevalence of certain polymorphisms in genes that influence warfarin pharmacokinetics and pharmacodynamics (e.g. cytochrome P450 2C9 and vitamin K epoxide reductase). The Asian population generally appear to require the lowest daily dose of warfarin to maintain a given INR target, with the White population requiring an intermediate daily dose and the Black population requiring the highest daily dose. These differences must be taken into account when administering warfarin in order to minimize the risk of under- or over-anticoagulation.In summary, warfarin is highly effective in preventing ischaemic strokes in White patients with AF at a modestly higher risk of ICH. Whether the same net clinical benefit extends to persons of colour is unproven. Given the rapidly changing demographic nationally and internationally, additional research is needed to resolve this important question.

Patient perceptions of 595 nm pulsed dye laser through glass compression in the treatment of thick port wine stains and superficial venous malformations.

In treating thickened port wine stains and superficial venous malformations with the 595 nm pulse dye laser, we have sometimes compressed the lesion with a glass slide to enable the laser beam to penetrate more deeply. In order to evaluate the patients' perception of this modality, 54 subjects were treated with glass compression using ice applications to cool the skin surface and without glass compression using a cryospray to cool the surface. The subjects were asked to rate the difference in 2 questionnaires after the first and second treatments as to effectiveness, pain of procedure, and overall preference. Of those subjects who perceived a difference between modalities, a significant number perceived treatments with glass compression to be more effective than without (p=0.0002 and p=0.0006), but more painful (p<0.0001). There was no significant difference in overall preference. Blistering occurred in 5 subjects when the glass slide was left on the skin more than 1 minute between ice applications.

Implantable defibrillators for secondary prevention of sudden cardiac death in cardiac surgery patients with perioperative ventricular arrhythmias.

BACKGROUND: Randomized studies of implantable cardioverter defibrillators (ICD) have excluded sudden cardiac death survivors who had revascularization before or after an arrhythmic event. To evaluate the role of ICD and the effects of clinical variables including degree of revascularization, we studied cardiac surgery patients who had an ICD implanted for sustained perioperative ventricular arrhythmias. METHODS AND RESULTS: The electronic database for Southern California Kaiser Foundation hospitals was searched for patients who had cardiac surgery between 1999 and 2005 and an ICD implanted within 3 months of surgery. One hundred sixty-four patients were identified; 93/164 had an ICD for sustained pre- or postoperative ventricular tachycardia or fibrillation requiring resuscitation. Records were reviewed for the following: presenting arrhythmia, ejection fraction, and degree of revascularization. The primary end point was total mortality (TM) and/or appropriate ICD therapy (ICD-T), and secondary end points are TM and ICD-T. During the mean follow up of 49 months, the primary endpoint of TM+ICD-T and individual end points of TM and ICD-T were observed in 52 (56%), 35 (38%), and 28 (30%) patients, respectively, with 55% of TM, and 23% of ICD-T occurring within 2 years of implant. In multivariate risk analysis, none of the following was associated with any of the end points: incomplete revascularization, presenting ventricular arrhythmia, and timing of arrhythmias. CONCLUSION: Our data supports the recent guidelines for ICD in this cohort of patients, as the presence of irreversible substrate and triggers of ventricular arrhythmias, cannot be reliably excluded even with complete revascularization. Further studies are needed to understand this complex group of patients.

Agreement between medical record and parent report for evaluation of childhood febrile seizures.

BACKGROUND: The monitoring of vaccine safety is critical to maintaining the public acceptance of vaccines required to ensure their continued success. Methods used to assess adverse events following immunization (AEFI) must accurately reflect their occurrence. Assessment of AEFI is often done via medical record review (MR) or via patient report (PR). However, these sources of data have not previously been compared for the analysis of AEFI. The objective of this study was to evaluate the concordance between MR and PR for young children identified as having had a febrile seizure (FS), an important AEFI, in an integrated health care system. The variables chosen for analysis were those recommended by the Brighton Collaboration Seizure Working Group for the evaluation of generalized seizure as an AEFI [1]. METHODS: Parent report from phone interviews and mailed questionnaires was compared to abstracted medical records of 110 children with FS between ages 3 and 60 months. Concordance between PR and MR for characteristics and predisposing factors of FS was assessed by percent total agreement and kappa statistic. RESULTS: Percent total agreement between PR and MR was between 43.6 and 100% for variables studied, with 62.5% of items having >70% agreement. However, kappa was poor to fair for all measures (-0.04 to 0.33). While some variables, such as history of seizures in a sibling or parent and several seizure characteristics, were reported more often by PR, other items, such as maximum fever and several concurrent conditions, were reported more often by MR. CONCLUSION: These findings demonstrate the limitations of using MR or PR alone to assess febrile seizures in children. This analysis supports the practice of collecting data from both MR and PR to most accurately portray the spectrum of predisposing factors and seizure characteristics when evaluating FS in children whenever feasible.

Smaller platelet volumes associated with vascular malformations.

Various parameters in 91 adult participants with vascular malformations and 91 controls were studied. The mean of the participants' platelet volumes was 8.5 fL and that of their controls was 9.1 (P < .001). The mean of the participants' platelet mass was 2145 µL/L of blood and that of their controls was 2351 (P = .006). The other parameters studied were not significantly different than the controls. It is suggested that the lower platelet volume might be related to a compensatory mechanism to keep the total body platelet mass stable despite the increased vasculature.

Impact of MMRV combination vaccine on childhood vaccination compliance.

OBJECTIVE: To assess the impact of using the combined measles, mumps, rubella, and varicella vaccine (MMRV) instead of the measles, mumps, and rubella vaccine and the varicella vaccine separately (MMR+V) on uptake of vaccines recommended by the Advisory Committee for Immunization Practices (ACIP) in young children. STUDY DESIGN: Retrospective cohort study. METHODS: Electronic immunization records of children 12 to 15 months of age who received either MMR+V (n = 29,716) or MMRV (n = 29,711) between November 2003 and June 2007 while enrolled in Kaiser Permanente Southern California were evaluated. Proportions of children who received either MMRV or MMR+V and other ACIP-recommended vaccines either simultaneously or during recommended age intervals were compared. RESULTS: Concomitant administration of DTaP (76.3 vs 75.6%), PCV7 (89.1 vs 78.6%), Hib (92.3 vs 91.3%), and hepatitis A vaccine (HAV) (44.2 vs 0.1%) and on-time administration of PCV7 (91.7 vs 78.7%), Hib (93.9 vs 93.2%), and HAV (86.8 vs 24.3%) were greater with MMRV than with MMR+V. On-time administration of DTaP (91.4 vs 90.5%) and IPV (91.3 vs 90.0%) was greater with MMR+V than with MMRV. CONCLUSIONS: Concomitant and on-time administration of most ACIP-recommended vaccines was greater with MMRV than with MMR+V despite the addition of HAV to the recommended schedule after introduction of MMRV. However, the modest compliance increases suggest that focusing on other barriers to compliance may be important to increasing adherence to future vaccination recommendations.

Observational safety study of febrile convulsion following first dose MMRV vaccination in a managed care setting.

BACKGROUND: A combined measles, mumps, rubella, varicella live vaccine (MMRV, Merck and Co., Inc., US) was recently licensed in the US. Pre-licensure clinical trial data showed a significant increase in fever in days 5-12 following MMRV vaccination as compared to the vaccines given separately (MMR+V). This post-licensure retrospective cohort study was undertaken to assess the incidence of febrile convulsion following MMRV. METHODS: Children ages 12-60 months who received a first dose of MMRV in February 2006-June 2007 in a managed care organization were included in the study. Subjects were optimally matched on age, sex, and calendar date of vaccination to children who received MMR+V concomitantly in November 2003-January 2006, before MMRV licensure. Potential cases of febrile convulsion were identified through administrative data and adjudicated by expert panel, according to pre-specified criteria. RESULTS: During the 30 days post-vaccination, there were 128 and 94 potential convulsion cases among the 31,298 children in the MMRV and MMR+V cohorts, respectively. After review of available medical charts and adjudication, there were 84 cases of confirmed febrile convulsion, 44 (1.41/1000) and 40 (1.28/1000) in the MMRV and MMR+V cohorts, respectively (RR=1.10, 95% CI=0.72, 1.69). In days 5-12 following vaccination, a pre-specified period of interest, the respective numbers were 22 (0.70/1000) and 10 (0.32/1000) (RR=2.20, 95% CI=1.04, 4.65). CONCLUSION: These data suggest that the risk of febrile convulsion is increased in days 5-12 following vaccination with MMRV as compared to MMR+V given separately during the same visit, when post-vaccination fever and rash are also increased in clinical trials. While there was no evidence of an increase in the overall month following vaccination, the elevated risk during this time period should be communicated and needs to be balanced with the potential benefit of a combined vaccine.

Racial/ethnic differences in the risk of intracranial hemorrhage among patients with atrial fibrillation.

OBJECTIVES: This study was designed to study racial/ethnic differences in the risk for intracranial hemorrhage (ICH) and the effect of warfarin on ICH risk among patients with atrial fibrillation (AF). BACKGROUND: Nonwhites are at greater risk for ICH than whites in the general population. Whether this applies to patients with AF and whether warfarin therapy is associated with comparable risk of ICH in nonwhites are unknown. METHODS: We retrospectively identified a multiethnic stroke-free cohort hospitalized with nonrheumatic AF. Warfarin use and anticoagulation intensity were assessed by searching pharmacy and laboratory records. Crude ICH event rates were calculated by Poisson regression. Cox proportional hazard models were constructed to assess the independent effect of race/ethnicity on ICH after adjusting for age, gender, hypertension, diabetes, heart failure, and warfarin exposure. RESULTS: Between 1995 and 2000, we identified 18,867 qualifying AF hospitalizations (78.5% white, 8% black, 9.5% Hispanic, and 3.9% Asian) and 173 qualifying ICH events over 3.3 years follow-up. Achieved anticoagulation intensity was lower among blacks but not different between the other groups. Warfarin was associated with increased ICH risk in all races, but the magnitude of risk was greater among nonwhites. There were no gender differences. The hazard ratio for ICH with whites as referent was 4.06 for Asians (95% confidence interval [CI] 2.47 to 6.65), 2.06 for Hispanics (95% CI 1.31 to 3.24), and 2.04 (95% CI 1.25 to 3.35) for blacks. CONCLUSIONS: Nonwhites with AF were at greater risk for warfarin-related ICH. Blacks, Hispanics, and Asians were at successively greater ICH risk than whites.

Prognostic value of pleural fluid pH in malignant epithelial mesothelioma after talc poudrage.

BACKGROUND: Current staging schemes for malignant mesothelioma are inadequate. The most accurate staging may require pneumonectomy - a procedure associated with many complications. The pH of pleural fluid (ppH) predicts survival in non-mesotheliomatous malignant pleural effusions, suggesting that this noninvasive test might be useful for prognostication in malignant mesothelioma. OBJECTIVE: It was the aim of this study to determine whether baseline ppH correlates with survival in malignant epithelial pleural mesothelioma. METHODS: We reviewed survival data in patients treated with thoracoscopic talc pleurodesis whose final diagnosis was epithelial malignant pleural mesothelioma and whose chart recorded a ppH determination performed just before thoracoscopy. We monitored 26 patients until April 2002 (25 of these patients died), identifying cutoff ppH values that discriminate best for survival; Cox proportional hazards models were recursively run by increasing the ppH cutoff value by 0.02 each time. RESULTS: The mean follow-up time was 19+/-14 months. Mean ppH was 7.30+/-0.09, and median ppH was 7.32. Several cutoff points correlated with a statistically significant difference in survival, but ppH 7.32 was associated with the greatest value for the area under the curve. Patients with ppH>.32 lived a median of 21.2 months (95% confidence interval 16.5-30.0 months) after diagnosis compared with patients who had ppH

Prolonged survival after talc poudrage for malignant pleural mesothelioma: case series.

OBJECTIVE: Malignant pleural mesothelioma is a fatal disease with a mean life expectancy of 6-12 months. Since 1982, we have performed thoracoscopic talc poudrage (TTP) as a primary therapy in mesothelioma patients presenting with pleural effusion. As the survival data for our patients surpassed that of many published series, the patient data was analyzed to determine whether talc poudrage can be considered as a contemporary palliative option. METHODOLOGY: We reviewed all 26 patients with a final diagnosis of malignant pleural mesothelioma from our prospective database of 228 consecutive patients who received thoracoscopy from the same physician for recurrent symptomatic pleural effusion. Patients were followed up until their death. RESULTS: Mean survival after TTP was 23.8 +/- 16.3 months (median 19.4, range 2.9-68). Pleurodesis palliated dyspnoea in all patients. No perioperative deaths and one postoperative complication (pneumonia) occurred. Mean hospital stay was 3.9 +/- 2.7 days. CONCLUSION: TTP remains a safe, low-morbidity, inexpensive primary palliative treatment option for malignant pleural mesothelioma and a valid control arm option for therapeutic trials. TTP is ideal for patients who wish to avoid thoracotomy, long hospital stays and morbidity from multimodality therapy. Prospective randomized studies are needed to compare quality of life and survival after talc poudrage and other therapies.

Irritable bowel syndrome and surgery: a multivariable analysis.

BACKGROUND & AIMS: Patients with irritable bowel syndrome (IBS) have high surgical rates. We investigated the demographic and medical factors independently associated with surgical histories of health examinees. METHODS: We applied multiple stepwise logistic regression analysis to self-completed questionnaire data from 89,008 examinees, assessing 6 surgeries as outcomes. We assessed questionnaire/physician record agreement of physician-diagnosed IBS and surgical history on 201 randomly selected examinees with > or =3 years of records. RESULTS: Questionnaire/record agreement for IBS and surgery was 83.6% (kappa = 0.68) and 95.5%-100.0% (kappa = 0.82-1), respectively. IBS was reported by 4587 examinees (5.2%) (1382 men [3.0%] and 3205 women [7.5%]). Subjects with and without IBS, respectively, reported the following surgical procedures: cholecystectomy, 569 (12.4%) versus 3428 (4.1%), P < 0.0001; appendectomy, 967 (21.1%) versus 9906 (11.7%), P < 0.0001; hysterectomy, 1063 (33.2%) versus 6751 (17.0%), P < 0.0001; back surgery, 201 (4.4%) versus 2436 (2.9%), P < 0.0001; coronary artery surgery, 127 (2.8%) versus 2033 (2.4%), P > 0.05; peptic ulcer surgery, 22 (0.5%) versus 277 (0.3%), P > 0.05. Among independent surgery associations, IBS was associated with cholecystectomy (adjusted odds ratio [OR], 2.09; 95% confidence interval [CI], 1.89-2.31; P < 0.0001), appendectomy (OR, 1.45; 95% CI, 1.33-1.56; P < 0.0001), hysterectomy (OR, 1.70; 95% CI, 1.55-1.87; P < 0.0001), and back surgery (OR, 1.22; 95% CI, 1.05-1.43; P = 0.0084). CONCLUSIONS: Health examinees with physician-diagnosed IBS report rates of cholecystectomy 3-fold higher, appendectomy and hysterectomy 2-fold higher, and back surgery 50% higher than examinees without IBS; IBS is independently associated with these surgical procedures.