Marcela Horvitz-Lennon, Dongli Zhou, Sharon-Lise T Normand, Margarita Alegría, and Wes K Thompson. 2011. “Racial and ethnic service use disparities among homeless adults with severe mental illnesses receiving ACT.” Psychiatr Serv, 62, 6, Pp. 598-604.Abstract
OBJECTIVE: Case management-based interventions aimed at improving quality of care have the potential to narrow racial and ethnic disparities among people with chronic illnesses. The aim of this study was to assess the equity effects of assertive community treatment (ACT), an evidence-based case management intervention, among homeless adults with severe mental illness. METHODS: This study used baseline, three-, and 12-month data for 6,829 black, Latino, and white adults who received ACT services through the ACCESS study (Access to Community Care and Effective Services and Support). Zero-inflated Poisson random regression models were used to estimate the adjusted probability of use of outpatient psychiatric services and, among service users, the intensity of use. Odds ratios and rate ratios (RRs) were computed to assess disparities at baseline and over time. RESULTS: No disparities were found in probability of use at baseline or over time. Compared with white users, baseline intensity of use was lower for black users (RR=.89; 95% confidence interval [CI]=.83-.96) and Latino users (RR=.65; CI=.52-.81]). Intensity did not change over time for whites, but it did for black and Latino users. Intensity increased for blacks between baseline and three months (RR=1.11, CI=1.06-1.17]) and baseline and 12 months (RR=1.17, CI=1.11-1.22]). Intensity of use dropped for Latinos between baseline and three months (RR=.83, CI=.70-.98). CONCLUSIONS: Receipt of ACT was associated with a reduction in service use disparities for blacks but not for Latinos. Findings suggest that ACT's equity effects differ depending on race-ethnicity.
Laura Mauri, Sharon-Lise T Normand, Michael Pencina, Donald E Cutlip, Cathy Jeon, Paul Dreyer, Richard E Kuntz, Donald S Baim, and Alice K Jacobs. 2011. “Rationale and design of the MASS COMM trial: A randomized trial to compare percutaneous coronary intervention between MASSachusetts hospitals with cardiac surgery on-site and COMMunity hospitals without cardiac surgery on-site.” Am Heart J, 162, 5, Pp. 826-31.Abstract
BACKGROUND: Emergency surgery has become an increasingly rare event after percutaneous coronary intervention (PCI). There have been no randomized trials evaluating whether cardiac surgery services on-site are essential for patient safety and optimal outcomes during and after PCI. STUDY DESIGN: The MASS COMM trial ( no. NCT01116882) is a randomized trial comparing the safety and effectiveness of nonemergency PCI at hospitals without surgery on-site (SOS) (non-SOS hospitals) and hospitals with SOS (SOS hospitals). A total of 3,690 subjects will be randomized in a 3:1 fashion to undergo PCI at non-SOS and SOS hospitals, with follow-up at hospital discharge, 30 days, and 12 months after PCI. The rate of major adverse cardiac events (all-cause mortality, myocardial infarction, repeat revascularization, and stroke) will serve as the primary safety end point at 30 days and the primary effectiveness end point at 12 months. The design is a 1-way randomized trial with a statistical hypothesis of noninferiority of nonemergency PCI at non-SOS hospitals for both safety and effectiveness end points. CONCLUSIONS: This multicenter, randomized trial will compare the relative safety and effectiveness of nonemergency PCI at sites with and without cardiac SOS.
Catherine A Fullerton, Alisa B Busch, Sharon-Lise T Normand, Thomas G McGuire, and Arnold M Epstein. 2011. “Ten-year trends in quality of care and spending for depression: 1996 through 2005.” Arch Gen Psychiatry, 68, 12, Pp. 1218-26.Abstract
CONTEXT: During the past decade, the introduction of generic versions of newer antidepressants and the release of Food and Drug Administration warnings regarding suicidality in children, adolescents, and young adults may have had an effect on cost and quality of depression treatment. OBJECTIVES: To examine longitudinal trends in health service utilization, spending, and quality of care for depression. DESIGN: Observational trend study. SETTING: Florida Medicaid enrollees, between July 1, 1996, and June 30, 2006. Patients  Annual cohorts aged 18 to 64 years diagnosed as having depression. MAIN OUTCOME MEASURES: Mental health care spending (adjusted for inflation and case mix), as well as its components, including inpatient, outpatient, and medication expenditures. Quality-of-care measures included medication adherence, psychotherapy, and follow-up visits. RESULTS: Mental health care spending increased from a mean of $2802 per enrollee to $3610 during this period (29% increase). This increase occurred despite a mean decrease in inpatient spending from $641 per enrollee to $373 and was driven primarily by an increase in pharmacotherapy spending (up 110%), the bulk of which was due to spending on antipsychotics (949% increase). The percentage of enrollees with depression who were hospitalized decreased from 9.1% to 5.1%, and the percentage who received psychotherapy decreased from 56.6% to 37.5%. Antidepressant use increased from 80.6% to 86.8%, anxiety medication use was unchanged at 62.7% and 64.4%, and antipsychotic use increased from 25.9% to 41.9%. Changes in quality of care were mixed, with antidepressant use improving slightly, psychotherapy utilization fluctuating, and follow-up visits decreasing. CONCLUSIONS: During a 10-year period, spending for Medicaid enrollees with depression increased substantially, with minimal improvements in quality of care. Antipsychotic use contributed significantly to the increase in spending, while contributing little to traditional measures of quality of care.
Kristin M Tyler, Sharon-Lise T Normand, and Nicholas J Horton. 2011. “The use and abuse of multiple outcomes in randomized controlled depression trials.” Contemp Clin Trials, 32, 2, Pp. 299-304.Abstract
OBJECTIVE: Multiple outcomes are commonly analyzed in randomized trials. Interpretation of the results of trials with many outcomes is not always straightforward. We characterize the prevalence and factors associated with multiple outcomes in reports of clinical trials of depression, methods used to account for these outcomes, and concordance between published analyses and original protocol specifications. METHODS: A PubMed search for randomized controlled depression trials that included multiple outcomes published between January 2007 and October 2008 in 6 medical journals. Original study protocols were reviewed where available. Parallel data collection by 2 abstractors was used to determine trial registration information, the number of outcomes, and analytical method. RESULTS: Of the 55 included trials, nearly half of the papers reported more than 1 primary outcome, while almost all (90.9%, n = 50) reported more than 2 combined primary or secondary outcomes. Relatively few of the studies (5.8%, n = 3) adjusted for multiple outcomes. While most studies had published protocols in clinical trial registries (76.4%, n = 42), many did not specify outcomes in the protocol (n = 11) and a number had discrepancies with the published report. CONCLUSIONS: Multiple outcomes are prevalent in randomized controlled depression trials and appropriate statistical analyses to account for these methods are rarely used. Not all studies filed protocols, and there were discrepancies between these protocols and published reports. These issues complicate interpretability of trial results, and in some cases may lead to spurious conclusions. Promulgation of guidelines to improve analysis and reporting of multiple outcomes is warranted.
Frank B Yoon, Haiden A Huskamp, Alisa B Busch, and Sharon-Lise T Normand. 2011. “Using Multiple Control Groups and Matching to Address Unobserved Biases in Comparative Effectiveness Research: An Observational Study of the Effectiveness of Mental Health Parity.” Stat Biosci, 3, 1, Pp. 63-78.Abstract
Studies of large policy interventions typically do not involve randomization. Adjustments, such as matching, can remove the bias due to observed covariates, but residual confounding remains a concern. In this paper we introduce two analytical strategies to bolster inferences of the effectiveness of policy interventions based on observational data. First, we identify how study groups may differ and then select a second comparison group on this source of difference. Second, we match subjects using a strategy that finely balances the distributions of key categorical covariates and stochastically balances on other covariates. An observational study of the effect of parity on the severely ill subjects enrolled in the Federal Employees Health Benefits (FEHB) Program illustrates our methods.
John A Spertus, Robert O Bonow, Paul Chan, George A Diamond, Joseph P Drozda, Sanjay Kaul, Harlan M Krumholz, Frederick A Masoudi, Sharon-Lise T Normand, Eric D Peterson, Martha J Radford, and John S Rumsfeld. 2010. “ACCF/AHA new insights into the methodology of performance measurement: a report of the American College of Cardiology Foundation/American Heart Association Task Force on performance measures.” Circulation, 122, 20, Pp. 2091-106.
John A Spertus, Robert O Bonow, Paul Chan, George A Diamond, Joseph P Drozda, Sanjay Kaul, Harlan M Krumholz, Frederick A Masoudi, Sharon-Lise T Normand, Eric D Peterson, Martha J Radford, and John S Rumsfeld. 2010. “ACCF/AHA new insights into the methodology of performance measurement: a report of the American College of Cardiology Foundation/American Heart Association Task Force on performance measures.” J Am Coll Cardiol, 56, 21, Pp. 1767-82.
David M Shahian, Sean M O'Brien, Sharon-Lise T Normand, Eric D Peterson, and Fred H Edwards. 2010. “Association of hospital coronary artery bypass volume with processes of care, mortality, morbidity, and the Society of Thoracic Surgeons composite quality score.” J Thorac Cardiovasc Surg, 139, 2, Pp. 273-82.Abstract
OBJECTIVE: This study examines the association of hospital coronary artery bypass procedural volume with mortality, morbidity, evidence-based care processes, and Society of Thoracic Surgeons composite score. METHODS: The study population consisted of 144,526 patients from 733 hospitals that submitted data to the Society of Thoracic Surgeons Adult Cardiac Database in 2007. End points included use of National Quality Forum-endorsed process measures (internal thoracic artery graft; preoperative beta-blockade; and discharge beta-blockade, antiplatelet agents, and lipid drugs), operative mortality (in-hospital or 30-day), major morbidity (stroke, renal failure, reoperation, sternal infection, and prolonged ventilation), and Society of Thoracic Surgeons composite score. Procedural volume was analyzed as a continuous variable and by volume strata (< 100, 100-149, 150-199, 200-299, 300-449, and > or = 450). Analyses were performed with logistic and multivariate hierarchical regression modeling. RESULTS: Unadjusted mortality decreased across volume categories from 2.6% (< 100 cases) to 1.7% (> 450 cases, P < .0001), and these differences persisted after risk factor adjustment (odds ratio for lowest- vs highest-volume group, 1.49). Care processes and morbidity end points were not associated with hospital procedural volume except for a trend (P = .0237) toward greater internal thoracic artery use in high-volume hospitals. The average composite score for the lowest volume (< 100 cases) group was significantly lower than that of the 2 highest-volume groups, but only 1% of composite score variation was explained by volume. CONCLUSION: A volume-performance association exists for coronary artery bypass grafting but is weaker than that of other major complex procedures. There is considerable outcomes variability not explained by hospital volume, and low volume does not preclude excellent performance. Except for internal thoracic artery use, care processes and morbidity rates were not associated with volume.
Frederic S Resnic, Thomas P Gross, Danica Marinac-Dabic, Nilsa Loyo-Berrios, Sharon Donnelly, Sharon-Lise T Normand, and Michael E Matheny. 2010. “Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices.” JAMA, 304, 18, Pp. 2019-27.Abstract
CONTEXT: Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety. OBJECTIVE: To determine whether automated safety surveillance of clinical registries using a computerized tool can provide early warnings regarding the safety of new cardiovascular devices. DESIGN, SETTING, AND PATIENTS: Prospective propensity-matched cohort analysis of 7 newly introduced cardiovascular devices, using clinical data captured in the Massachusetts implementation of the National Cardiovascular Data Repository CathPCI Registry for all adult patients undergoing percutaneous coronary intervention from April 2003 through September 2007 in Massachusetts. MAIN OUTCOME MEASURE: Presence of any safety alert, triggered if the cumulative observed risk for a given device exceeded the upper 95% confidence interval (CI) of comparator control device. Predefined sensitivity analyses assessed robustness of alerts when triggered. RESULTS: We evaluated 74,427 consecutive interventional coronary procedures. Three of 21 safety analyses triggered sustained alerts in 2 implantable devices. Patients receiving Taxus Express2 drug-eluting stents experienced a 1.28-fold increased risk of postprocedural myocardial infarction (2.87% vs 2.25%; absolute risk increase, 0.62% [95% CI, 0.25%-0.99%]) and a 1.21-fold increased risk of major adverse cardiac events (4.24% vs 3.50%; absolute increase, 0.74% [95% CI, 0.29%-1.19%]) compared with those receiving alternative drug-eluting stents. Patients receiving Angio-Seal STS vascular closure devices experienced a 1.51-fold increased risk of major vascular complications (1.09% vs 0.72%; absolute increased risk, 0.37% [95% CI, 0.03%-0.71%]) compared with those receiving alternative vascular closure devices. Sensitivity analyses confirmed increased risk following use of the Taxus Express2 stent but not the Angio-Seal STS device. CONCLUSION: Automated prospective surveillance of clinical registries is feasible and can identify low-frequency safety signals for new cardiovascular devices.
Brian H Neelon, James A O'Malley, and Sharon-Lise T Normand. 2010. “A Bayesian model for repeated measures zero-inflated count data with application to outpatient psychiatric service use.” Stat Modelling, 10, 4, Pp. 421-439.Abstract
In applications involving count data, it is common to encounter an excess number of zeros. In the study of outpatient service utilization, for example, the number of utilization days will take on integer values, with many subjects having no utilization (zero values). Mixed-distribution models, such as the zero-inflated Poisson (ZIP) and zero-inflated negative binomial (ZINB), are often used to fit such data. A more general class of mixture models, called hurdle models, can be used to model zero-deflation as well as zero-inflation. Several authors have proposed frequentist approaches to fitting zero-inflated models for repeated measures. We describe a practical Bayesian approach which incorporates prior information, has optimal small-sample properties, and allows for tractable inference. The approach can be easily implemented using standard Bayesian software. A study of psychiatric outpatient service use illustrates the methods.
Thomas W Concannon, David M Kent, Sharon-Lise Normand, Joseph P Newhouse, John L Griffith, Joshua Cohen, Joni R Beshansky, John B Wong, Thomas Aversano, and Harry P Selker. 2010. “Comparative effectiveness of ST-segment-elevation myocardial infarction regionalization strategies.” Circ Cardiovasc Qual Outcomes, 3, 5, Pp. 506-13.Abstract
BACKGROUND: Primary percutaneous coronary intervention (PCI) is more effective on average than fibrinolytic therapy in the treatment of ST-segment-elevation myocardial infarction. Yet, most US hospitals are not equipped for PCI, and fibrinolytic therapy is still widely used. This study evaluated the comparative effectiveness of ST-segment-elevation myocardial infarction regionalization strategies to increase the use of PCI against standard emergency transport and care. METHODS AND RESULTS: We estimated incremental treatment costs and quality-adjusted life expectancies of 2000 patients with ST-segment-elevation myocardial infarction who received PCI or fibrinolytic therapy in simulations of emergency care in a regional hospital system. To increase access to PCI across the system, we compared a base case strategy with 12 hospital-based strategies of building new PCI laboratories or extending the hours of existing laboratories and 1 emergency medical services-based strategy of transporting all patients with ST-segment-elevation myocardial infarction to existing PCI-capable hospitals. The base case resulted in 609 (95% CI, 569-647) patients getting PCI. Hospital-based strategies increased the number of patients receiving PCI, the costs of care, and quality-adjusted life years saved and were cost-effective under a variety of conditions. An emergency medical services-based strategy of transporting every patient to an existing PCI facility was less costly and more effective than all hospital expansion options. CONCLUSION: Our results suggest that new construction and staffing of PCI laboratories may not be warranted if an emergency medical services strategy is both available and feasible.
Eric S Holmboe, Weifeng Weng, Gerald K Arnold, Sherrie H Kaplan, Sharon-Lise Normand, Sheldon Greenfield, Sarah Hood, and Rebecca S Lipner. 2010. “The comprehensive care project: measuring physician performance in ambulatory practice.” Health Serv Res, 45, 6 Pt 2, Pp. 1912-33.Abstract
OBJECTIVE: To investigate the feasibility, reliability, and validity of comprehensively assessing physician-level performance in ambulatory practice. DATA SOURCES/STUDY SETTING: Ambulatory-based general internists in 13 states participated in the assessment. STUDY DESIGN: We assessed physician-level performance, adjusted for patient factors, on 46 individual measures, an overall composite measure, and composite measures for chronic, acute, and preventive care. Between- versus within-physician variation was quantified by intraclass correlation coefficients (ICC). External validity was assessed by correlating performance on a certification exam. DATA COLLECTION/EXTRACTION METHODS: Medical records for 236 physicians were audited for seven chronic and four acute care conditions, and six age- and gender-appropriate preventive services. PRINCIPAL FINDINGS: Performance on the individual and composite measures varied substantially within (range 5-86 percent compliance on 46 measures) and between physicians (ICC range 0.12-0.88). Reliabilities for the composite measures were robust: 0.88 for chronic care and 0.87 for preventive services. Higher certification exam scores were associated with better performance on the overall (r = 0.19; p<.01), chronic care (r = 0.14, p = .04), and preventive services composites (r = 0.17, p = .01). CONCLUSIONS: Our results suggest that reliable and valid comprehensive assessment of the quality of chronic and preventive care can be achieved by creating composite measures and by sampling feasible numbers of patients for each condition.
Jersey Chen, Harlan M Krumholz, Yun Wang, Jeptha P Curtis, Saif S Rathore, Joseph S Ross, Sharon-Lise T Normand, Geoffrey C Schreiner, Gregory Mulvey, and Brahmajee K Nallamothu. 2010. “Differences in patient survival after acute myocardial infarction by hospital capability of performing percutaneous coronary intervention: implications for regionalization.” Arch Intern Med, 170, 5, Pp. 433-9.Abstract
BACKGROUND: There are increasing calls for regionalization of acute myocardial infarction (AMI) care in the United States to hospitals with the capacity to perform percutaneous coronary intervention (PCI). Whether regionalization will improve outcomes depends in part on the magnitude of existing differences in outcomes between PCI and non-PCI hospitals within the same health care region. METHODS: A 100% sample of claims from Medicare fee-for-service beneficiaries 65 years or older hospitalized for AMI between January 1, 2004, and December 31, 2006, was used to calculate hospital-level, 30-day risk-standardized mortality rates (RSMRs). The RSMRs between PCI and local non-PCI hospitals were compared within local health care regions defined by hospital referral regions (HRRs). RESULTS: A total of 523 119 AMI patients was admitted to 1382 PCI hospitals, and 194 909 AMI patients were admitted to 2491 non-PCI hospitals in 295 HRRs with at least 1 PCI and 1 non-PCI hospital. Although PCI hospitals had lower RSMRs than non-PCI hospitals (mean, 16.1% vs 16.9%; P < .001), considerable overlap was seen in RSMRs between non-PCI and PCI hospitals within the same HRR. In 80 HRRs, the RSMRs at the best-performing PCI hospital were lower than those at local non-PCI hospitals by 3% or more. Among the remaining HRRs, the RSMRs at the best-performing PCI hospital were lower by 1.5% to 3.0% in 104 HRRs and by greater than 0 to 1.5% in 74 HRRs. In 37 HRRs, the RSMRs at the best-performing PCI hospital were no better or were higher than at local non-PCI hospitals. CONCLUSIONS: The magnitude of benefit from comprehensively regionalizing AMI care to PCI hospitals appears to vary greatly across HRRs. These findings support a tailored regionalization policy that targets areas with the greatest outcome differences between PCI and local non-PCI hospitals.
Art Sedrakyan, Danica Marinac-Dabic, Sharon-Lise T Normand, Alvin Mushlin, and Tom Gross. 2010. “A framework for evidence evaluation and methodological issues in implantable device studies.” Med Care, 48, 6 Suppl, Pp. S121-8.Abstract
Implantable medical devices (IMD) are frequently used in interventional medicine. There are a host of complex methodological issues to consider in conducting device studies. A general conceptual framework for evidence evaluation is needed to help investigators conduct comparative studies in this setting. It is known that clinical trials of implants require study design planning and creative execution that are quite different from those in pharmaceutical setting. Important study design issues such as randomization, masking and allocation concealment require unique approaches for each device. In addition, device comparative studies must cope with sources of variability different from pharmaceutical studies. These include operator learning curve effects, hospital-operator-patient interactions, and issues related to device technical characteristics. Observational studies of IMDs are particularly challenging. Selection of comparison groups, adjusting for confounding and addressing learning curve issues needs careful planning. We propose a general framework for IMD evaluation and provide an outline of the methodological issues that require further discussion. We hope this article will inspire and help to inform those interested in advancing comparative safety and effectiveness of IMDs and to plan and pursue future methodological work in this area.
Joseph S Ross, Sharon-Lise T Normand, Yun Wang, Dennis T Ko, Jersey Chen, Elizabeth E Drye, Patricia S Keenan, Judith H Lichtman, Héctor Bueno, Geoffrey C Schreiner, and Harlan M Krumholz. 2010. “Hospital volume and 30-day mortality for three common medical conditions.” N Engl J Med, 362, 12, Pp. 1110-8.Abstract
BACKGROUND: The association between hospital volume and the death rate for patients who are hospitalized for acute myocardial infarction, heart failure, or pneumonia remains unclear. It is also not known whether a volume threshold for such an association exists. METHODS: We conducted cross-sectional analyses of data from Medicare administrative claims for all fee-for-service beneficiaries who were hospitalized between 2004 and 2006 in acute care hospitals in the United States for acute myocardial infarction, heart failure, or pneumonia. Using hierarchical logistic-regression models for each condition, we estimated the change in the odds of death within 30 days associated with an increase of 100 patients in the annual hospital volume. Analyses were adjusted for patients' risk factors and hospital characteristics. Bootstrapping procedures were used to estimate 95% confidence intervals to identify the condition-specific volume thresholds above which an increased volume was not associated with reduced mortality. RESULTS: There were 734,972 hospitalizations for acute myocardial infarction in 4128 hospitals, 1,324,287 for heart failure in 4679 hospitals, and 1,418,252 for pneumonia in 4673 hospitals. An increased hospital volume was associated with reduced 30-day mortality for all conditions (P<0.001 for all comparisons). For each condition, the association between volume and outcome was attenuated as the hospital's volume increased. For acute myocardial infarction, once the annual volume reached 610 patients (95% confidence interval [CI], 539 to 679), an increase in the hospital volume by 100 patients was no longer significantly associated with reduced odds of death. The volume threshold was 500 patients (95% CI, 433 to 566) for heart failure and 210 patients (95% CI, 142 to 284) for pneumonia. CONCLUSIONS: Admission to higher-volume hospitals was associated with a reduction in mortality for acute myocardial infarction, heart failure, and pneumonia, although there was a volume threshold above which an increased condition-specific hospital volume was no longer significantly associated with reduced mortality.
Sharon-Lise T Normand. 2010. “Missing data and convenient assumptions.” Circ Cardiovasc Qual Outcomes, 3, 1, Pp. 2-3.
Susannah M Bernheim, Jacqueline N Grady, Zhenqiu Lin, Yun Wang, Yongfei Wang, Shantal V Savage, Kanchana R Bhat, Joseph S Ross, Mayur M Desai, Angela R Merrill, Lein F Han, Michael T Rapp, Elizabeth E Drye, Sharon-Lise T Normand, and Harlan M Krumholz. 2010. “National patterns of risk-standardized mortality and readmission for acute myocardial infarction and heart failure. Update on publicly reported outcomes measures based on the 2010 release.” Circ Cardiovasc Qual Outcomes, 3, 5, Pp. 459-67.Abstract
BACKGROUND: Patient outcomes provide a critical perspective on quality of care. The Centers for Medicare and Medicaid Services (CMS) is publicly reporting hospital 30-day risk-standardized mortality rates (RSMRs) and risk-standardized readmission rates (RSRRs) for patients hospitalized with acute myocardial infarction (AMI) and heart failure (HF). We provide a national perspective on hospital performance for the 2010 release of these measures. METHODS AND RESULTS: The hospital RSMRs and RSRRs are calculated from Medicare claims data for fee-for-service Medicare beneficiaries, 65 years or older, hospitalized with AMI or HF between July 1, 2006, and June 30, 2009. The rates are calculated using hierarchical logistic modeling to account for patient clustering, and are risk-adjusted for age, sex, and patient comorbidities. The median RSMR for AMI was 16.0% and for HF was 10.8%. Both measures had a wide range of hospital performance with an absolute 5.2% difference between hospitals in the 5th versus 95th percentile for AMI and 5.0% for HF. The median RSRR for AMI was 19.9% and for HF was 24.5% (3.9% range for 5th to 95th percentile for AMI, 6.7% for HF). Distinct regional patterns were evident for both measures and both conditions. CONCLUSIONS: High RSRRs persist for AMI and HF and clinically meaningful variation exists for RSMRs and RSRRs for both conditions. Our results suggest continued opportunities for improvement in patient outcomes for HF and AMI.
Joseph Romagnuolo, John Morris, Seth Palesch, Robert Hawes, David Lewin, and Katherine Morgan. 2010. “Natural orifice transluminal endoscopic surgery versus laparoscopic surgery for inadvertent colon injury repair: feasibility, risk of abdominal adhesions, and peritoneal contamination in a porcine survival model.” Gastrointest Endosc, 71, 4, Pp. 817-23.Abstract
BACKGROUND: Adhesions are common after conventional surgery; natural orifice transluminal endoscopic surgery (NOTES) avoids peritoneal disruption and may reduce adhesions. OBJECTIVES: To determine whether adhesions (and peritoneal contamination) are less common with NOTES transgastric colon injury and repair (TGCR) than with laparoscopic colon repair (LCR). DESIGN/SETTING: Porcine survival study. INTERVENTIONS: After colon preparation and administration of antibiotics, forty 25-kg male pigs were randomly assigned to either TGCR or LCR. TGCR involved an endoscopic gastrotomy (needle-knife plus balloon dilation), CO(2) pneumoperitoneum, and a 2-cm needle-knife transmural incision of spiral colon. Colotomies were repaired with clips; gastrotomies were closed with clips and a detachable snare. MAIN OUTCOME MEASUREMENTS: Adhesions were assessed at necropsy at 21 days; biopsy specimens were blindly reviewed. A 9-point adhesion score (density/vascularity, width, and extent) was averaged from 3 reviewers. Peritoneal lavage was sent for cell count and culture. RESULTS: Two of 20 TGCR pigs died immediately (unrecognized preoperative autopsy-proven pneumonia). The median procedure times were 70.5 and 19.0 minutes for TGCR and LCR, respectively; weight gains were 7.1 and 8.2 kg, respectively. The median adhesion scores were 4.3 and 3.7, respectively (P = .26); subscores were similar (1.9, 1.5, 1.3 vs 1.7, 1.1, 1.0, respectively (P = .3-.6)). Peritoneal lavage bacterial growth was nonsignificantly lower after TGCR than after LCR (38.9% vs 60.0%, respectively; P = .30); administration of intragastric antibiotics did not decrease contamination. Three TGCR (vs no LCR) pigs had histologic peritonitis. LIMITATIONS: Animal model, colon prepped, injury immediately recognized. CONCLUSION: NOTES colon repair is feasible after transmural injury. Adhesions, histologic peritonitis, and contamination were similar to those with laparoscopy and were not helped by intragastric antibiotics.
Yun-Ju Lee, Marco JM Hoozemans, and Jaap H van Dieën. 2010. “Oblique abdominal muscle activity in response to external perturbations when pushing a cart.” J Biomech, 43, 7, Pp. 1364-72.Abstract
Cyclic activation of the external and internal oblique muscles contributes to twisting moments during normal gait. During pushing while walking, it is not well understood how these muscles respond to presence of predictable (cyclic push-off forces) and unpredictable (external) perturbations that occur in pushing tasks. We hypothesized that the predictable perturbations due to the cyclic push-off forces would be associated with cyclic muscle activity, while external perturbations would be counteracted by cocontraction of the oblique abdominal muscles. Eight healthy male subjects pushed at two target forces and two handle heights in a static condition and while walking without and with external perturbations. For all pushing tasks, the median, the static (10th percentile) and the peak levels (90th percentile) of the electromyographic amplitudes were determined. Linear models with oblique abdominal EMGs and trunk angles as input were fit to the twisting moments, to estimate trunk stiffness. There was no significant difference between the static EMG levels in pushing while walking compared to the peak levels in pushing while standing. When pushing while walking, the additional dynamic activity was associated with the twisting moments, which were actively modulated by the pairs of oblique muscles as in normal gait. The median and static levels of trunk muscle activity and estimated trunk stiffness were significantly higher when perturbations occurred than without perturbations. The increase baseline of muscle activity indicated cocontraction of the antagonistic muscle pairs. Furthermore, this cocontraction resulted in an increased trunk stiffness around the longitudinal axis.
Peter K Lindenauer, Susannah M Bernheim, Jacqueline N Grady, Zhenqiu Lin, Yun Wang, Yongfei Wang, Angela R Merrill, Lein F Han, Michael T Rapp, Elizabeth E Drye, Sharon-Lise T Normand, and Harlan M Krumholz. 2010. “The performance of US hospitals as reflected in risk-standardized 30-day mortality and readmission rates for medicare beneficiaries with pneumonia.” J Hosp Med, 5, 6, Pp. E12-8.Abstract
BACKGROUND: Pneumonia is a leading cause of hospitalization and death in the elderly, and remains the subject of both local and national quality improvement efforts. OBJECTIVE: To describe patterns of hospital and regional performance in the outcomes of elderly patients with pneumonia. DESIGN: Cross-sectional study using hospital and outpatient Medicare claims between 2006 and 2009. SETTING: A total of 4,813 nonfederal acute care hospitals in the United States and its organized territories. PATIENTS: Hospitalized fee-for-service Medicare beneficiaries age 65 years and older who received a principal diagnosis of pneumonia. INTERVENTION: None. MEASUREMENTS: Hospital and regional level risk-standardized 30-day mortality and readmission rates. RESULTS: Of the 1,118,583 patients included in the mortality analysis 129,444 (11.6%) died within 30 days of hospital admission. The median (Q1, Q3) hospital 30-day risk-standardized mortality rate for patients with pneumonia was 11.1% (10.0%, 12.3%), and despite controlling for differences in case mix, ranged from 6.7% to 20.9%. Among the 1,161,817 patients included in the readmission analysis 212,638 (18.3%) were readmitted within 30 days of hospital discharge. The median (Q1, Q3) 30-day risk-standardized readmission rate was 18.2% (17.2%, 19.2%) and ranged from 13.6% to 26.7%. Risk-standardized mortality rates varied across hospital referral regions from a high of 14.9% to a low of 8.7%. Risk-standardized readmission rates varied across hospital referral regions from a high of 22.2% to a low of 15%. CONCLUSIONS: Risk-standardized 30-day mortality and, to a lesser extent, readmission rates for patients with pneumonia vary substantially across hospitals and regions and may present opportunities for quality improvement, especially at low performing institutions and areas.