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PubMed2006

Methodological aspects in the assessment of treatment effects in observational health outcomes studies.

Prospective observational studies, which provide information on the effectiveness of interventions in natural settings, may complement results from randomised clinical trials in the evaluation of health technologies. However, observational studies are subject to a number of potential methodological weaknesses, mainly selection and observer bias. This paper reviews and applies various methods to control for selection bias in the estimation of treatment effects and proposes novel ways to assess the presence of observer bias. We also address the issues of estimation and inference in a multilevel setting. We describe and compare the use of regression methods, propensity score matching, fixed-effects models incorporating investigator characteristics, and a multilevel, hierarchical model using Bayesian estimation techniques in the control of selection bias. We also propose to assess the existence of observer bias in observational studies by comparing patient- and investigator-reported outcomes. To illustrate these methods, we have used data from the SOHO (Schizophrenia Outpatient Health Outcomes) study, a large, prospective, observational study of health outcomes associated with the treatment of schizophrenia. The methods used to adjust for differences between treatment groups that could cause selection bias yielded comparable results, reinforcing the validity of the findings. Also, the assessment of observer bias did not show that it existed in the SOHO study. Observational studies, when properly conducted and when using adequate statistical methods, can provide valid information on the evaluation of health technologies.

Bayes Theorem↗

PubMedDate not supplied

Bringing geriatricians to the front lines: evaluation of a quality improvement intervention in primary care.

BACKGROUND: Frail elders often receive low-quality primary care, yet the optimal role of geriatricians in primary care settings remains uncertain. We evaluated the health utilization impacts of an innovative intervention emphasizing chronic disease self-management and physical activity promotion among frail elders in primary care. METHODS: The intervention was implemented within two primary care practices at a single clinic serving a large population of frail elders enrolled in a western Washington health plan. Subjects included older patients (age >or=65 years) with disproportionate baseline outpatient service use who attended two on-site visits with a geriatrician during which each received comprehensive assessment and a problem-solving intervention to enhance chronic disease self-management and promote physical activity (N = 146). Our evaluation had a retrospective matched cohort design. Controls receiving primary care at other health plan clinics were matched 3:1 to intervention subjects by sex and a propensity score (N = 437), which was computed using demographic, clinical, and health care utilization factors that were predictive of attending the intervention. Among intervention subjects and controls following the intervention, we compared relative rates of hospitalization, outpatient and specialty visits, nursing home admission, mortality, and prescription of selected high-risk medications, as well as total health care costs. RESULTS: From March 2002 to November 2003, the geriatrician evaluated 146 of 725 elderly subjects (20%) in the two primary care practices. During a mean follow-up of 1.3 years, intervention subjects had a reduced rate of hospitalization relative to matched controls (incidence rate ratio 0.57; 95% CI: 0.37 to 0.86; P < .01). Intervention and control subjects did not have significantly different rates of specialty visits, outpatient visits, nursing home admission, mortality, or high-risk prescriptions. Relative to matched controls during follow-up, total health care costs were 26.3% lower among intervention subjects (95% CI: 1.3%, 44.9%; P = .04). CONCLUSIONS: Outpatient geriatric interventions emphasizing collaboration between geriatricians and primary care physicians, chronic disease self-management, and physical activity may reduce hospitalization risk and total health care costs among vulnerable elders.

Aged↗

PubMed2006

Success rates of percutaneous coronary intervention of chronic total occlusions and long-term survival in patients with diabetes mellitus.

The objectives of this study were to evaluate angiographic and clinical outcomes among patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention (PCI) for a chronic total occlusion (CTO). We compared them with matched patients undergoing PCI of a non-CTO lesion. All patients had documented DM. Matching was performed using a propensity score for CTO. There were 506 patients with DM and CTO who were matched with a non-CTO group. Results showed that angiographic success rates were lower with CTO (75% vs. 93%, p<0.001). In-hospital major adverse cardiac event (MACE - death, urgent bypass surgery, Q-wave myocardial infarction or target vessel revascularisation) rates were equivalent (CTO 3.2% vs. non-CTO 2.6%, p=0.57). Survival was not different five years after revascularisation of CTO (75%) vs. non-CTO (79%) (p=0.20). In addition, when DM patients with CTO were analysed according to angiographic success of PCI, there were no significant differences in either in-hospital (success 1.6% vs. failure 2.4%, p=0.7) or 1-year mortality (success 22.2% vs. failure 26.8%, p=0.3). We conclude that PCI of CTO is safe in patients with DM. Angiographic failure is not associated with an increase in MACE rates or mortality as compared to matched non-CTO patients. However, there is not a measurable improvement in survival in this DM-CTO population.

Aged↗

PubMed2026

[Laryngeal squamous cell carcinoma-derived exosomes promote neuronal axonal growth by remodeling the neural microenvironment].

Objective: Perineural invasion (PNI) is a critical determinant of poor prognosis in laryngeal squamous cell carcinoma (LSCC), but its underlying mechanisms remain unclear. This study aimed to investigate whether LSCC-derived exosomes induce axonal growth by delivering neuroactive molecules, thereby contributing to tumor perineural invasion. Methods: Clinical data from the laryngeal cancer cohort of The Cancer Genome Atlas Head and Neck Squamous Cell Carcinoma (TCGA-HNSC) dataset were analyzed. Propensity score matching (PSM) and Cox regression were used to evaluate the prognostic value of nerve density, and these findings were validated using 35 pairs of laryngeal cancer and adjacent normal tissue specimens collected at Yantai Yuhuangding Hospital between 2022 and 2026 to assess neural morphological changes. Exosomes were isolated from the human LSCC cell line AMC-HN-8, characterized by quality-control assays, and co-cultured with PC12 cells. A rescue experiment using GW4869, a specific inhibitor of neutral sphingomyelinase, was performed to confirm the exosome-dependent effect. Neurite outgrowth was evaluated by immunofluorescence, and the expression of axonal growth-related genes was measured by RT-qPCR. Targeted metabolomics was employed for the absolute quantification of neuroactive metabolites within the vesicles and for pathway enrichment analysis. Results: After PSM adjustment, high nerve density was identified as an independent poor prognostic factor in LSCC patients (HR=2.10, P=0.035), with particularly pronounced prognostic value in the early-stage node-negative (N0) subgroup (HR=4.07, P=0.001). Pathological sections showed high expression of the neural markers βIII-tubulin and PGP9.5 in LSCC tissues (βIII-tubulin: t=2.234, P<0.05; PGP9.5: t=2.575, P<0.05). Exosomes were successfully isolated from AMC-HN-8 cells and passed quality control. In vitro assays showed that LSCC-derived exosomes significantly promoted neurite extension and branching in PC12 cells (t=4.147, P<0.000 1) and upregulated core axonal growth genes, including GAP-43, NEFL, and NEFM (GAP-43: t=3.698, P<0.05; NEFL: t=5.113, P<0.01; NEFM: t=5.263, P<0.01); this effect was completely reversed by the exosome-release inhibitor GW4869 (t=3.535, P<0.001). Targeted metabolomics revealed a specific enrichment of 12 neurotransmitters and metabolites within LSCC exosomes, centered on glutamine (83.411 μmol/L, FC=1.88) and glutamate (18.461 μmol/L, FC=1.21), which were significantly enriched in signaling pathways such as "central carbon metabolism in cancer" and "glutamatergic synapse". Conclusion: Nerve density is a potential adverse prognostic factor in patients with LSCC. LSCC-derived exosomes can directly induce axonal growth in neuron-like cells, suggesting that tumor cells actively remodel the neural microenvironment and drive axonal growth through exosome-mediated long-range signaling.

Exosomes↗

PubMed2004

Biochemical recurrence and survival prediction models for the management of clinically localized prostate cancer.

A number of new predictive modeling techniques have emerged in the past several years. These methods, which have been developed in fields such as artificial intelligence research, engineering, and meteorology, are now being applied to problems in medicine with promising results. This review outlines our recent work with use of selected advanced techniques such as artificial neural networks, genetic algorithms, and propensity scoring to develop useful models for estimating the risk of biochemical recurrence and long-term survival in men with clinically localized prostate cancer. In addition, we include a description of our efforts to develop a comprehensive prostate cancer database that, along with these novel modeling techniques, provides a powerful research tool that allows for the stratification of risk for treatment failure and survival by such factors as age, race, and comorbidities. Clinical and pathologic data from 1400 patients were used to develop the biochemical recurrence model. The area under the receiver operating characteristic curve for this model was 0.83, with a sensitivity of 85% and specificity of 74%. For the survival model, data from 6149 men were used. Our analysis indicated that age, income, and comorbidities had a statistically significant impact on survival. The effect of race did not reach statistical significance in this regard. The C index value for the model was 0.69 for overall survival. We conclude that these methods, along with a comprehensive database, allow for the development of models that provide estimates of treatment failure risk and survival probability that are more meaningful and clinically useful than those previously developed.

Aged↗

PubMed2002

Survival associated with 5-fluorouracil-based adjuvant chemotherapy among elderly patients with node-positive colon cancer.

BACKGROUND: Randomized clinical trials have demonstrated the efficacy of adjuvant 5-fluorouracil (5-FU)-based chemotherapy after surgical resection of node-positive colon cancer. Although this treatment became the standard in 1990 following a National Institutes of Health Consensus Conference, among those at least 65 years of age it is less likely to be offered to older or nonwhite patients. OBJECTIVE: To determine the association between 5-fu-based chemotherapy and survival in older patients. DESIGN: Retrospective cohort study. SETTING: Combined database of the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) program and Medicare. PATIENTS: 4768 patients 65 years of age or older who received a diagnosis of node-positive colon cancer from 1992 to 1996, were covered by Medicare Parts A and B, and resided in the population covered by the SEER program. MEASUREMENTS: Propensity scores to control for known predictors of receiving treatment, Cox proportional hazards models to assess the association of 5-FU therapy with survival, and sensitivity analyses to estimate the possible effects of unknown confounders. RESULTS: Fifty-two percent of patients received 5-FU therapy. For this sample, the hazard ratio for death associated with 5-FU therapy was 0.66 (95% CI, 0.60 to 0.73). Confounding could have accounted for this association only if an unmeasured confounder were extremely unequally distributed between the treated and untreated groups or increased mortality by at least 50%. CONCLUSIONS: 5-Fluorouracil adjuvant therapy is significantly associated with reduced mortality in older patients, similar to the association found in randomized, controlled trials among younger patients. More frequent use of 5-FU therapy in older patients would probably reduce death from colon cancer.

Age Factors↗

PubMed2004

Taking glucocorticoids by prescription is associated with subsequent cardiovascular disease.

BACKGROUND: Glucocorticoids have adverse systemic effects, including obesity, hypertension, and hyperglycemia, that may predispose to cardiovascular disease. The effect of glucocorticoid use on cardiovascular disease has not been quantified. OBJECTIVE: To test the hypothesis that users of exogenous glucocorticoids have an increased risk for cardiovascular disease. DESIGN: A cohort study using a record linkage database. SETTING: Tayside, Scotland, United Kingdom. PATIENTS: 68,781 glucocorticoid users and 82,202 nonusers without previous hospitalization for cardiovascular disease who were studied between 1993 and 1996. MEASUREMENTS: The average daily dose of glucocorticoid exposure during follow-up was categorized as low (inhaled, nasal, and topical only), medium (oral, rectal, or parenteral <7.5 mg of prednisolone equivalent), or high (> or =7.5 mg of prednisolone equivalent). Poisson regression model, sensitivity analysis, and propensity score methods were used to investigate the association between glucocorticoid exposure and cardiovascular outcome. RESULTS: 4383 cardiovascular events occurred in 257,487 person-years of follow-up for a rate of 17.0 (95% CI, 16.5 to 17.5) per 1000 person-years in the comparator group, and 5068 events occurred in 212,287 person-years for a rate of 23.9 (CI, 23.2 to 24.5) per 1000 person-years in the group exposed to glucocorticoids (22.1, 27.2, and 76.5 in low, medium, and high groups, respectively). The absolute risk difference was 6.9 (CI, 6.0 to 7.7) per 1000 person-years (5.1, 10.1, and 59.4, respectively). After adjustment for known covariates, the relative risk for a cardiovascular event in patients receiving high-dose glucocorticoids was 2.56 (CI, 2.18 to 2.99). LIMITATIONS: Because the data were observational, residual confounding cannot be excluded. CONCLUSION: Treatment with high-dose glucocorticoids seemed to be associated with increased risk for cardiovascular disease.

Cardiovascular Diseases↗

PubMed2005

Comparing the risk for death with peritoneal dialysis and hemodialysis in a national cohort of patients with chronic kidney disease.

BACKGROUND: The influence of type of dialysis on survival of patients with end-stage renal disease (ESRD) is controversial. OBJECTIVE: To compare risk for death among patients with ESRD who receive peritoneal dialysis or hemodialysis. DESIGN: Prospective cohort study. SETTING: 81 dialysis clinics in 19 U.S. states. PATIENTS: 1041 patients starting dialysis (274 patients receiving peritoneal dialysis and 767 patients receiving hemodialysis) at baseline. MEASUREMENTS: Patients were followed for up to 7 years and censored at transplantation or loss to follow-up. Cox proportional hazards regression stratified by clinic was used to compare the risk for death with peritoneal dialysis versus hemodialysis. RESULTS: Twenty-five percent of patients undergoing peritoneal dialysis and 5% of hemodialysis patients switched type of dialysis. After adjustment, the risk for death did not differ between patients undergoing peritoneal dialysis and those undergoing hemodialysis during the first year (relative hazard, 1.39 [95% CI, 0.64 to 3.06]), but the risk became significantly higher among those undergoing peritoneal dialysis in the second year (relative hazard, 2.34 [CI, 1.19 to 4.59]). After stratification, the survival rate was no different for patients who had the highest propensity of being initially treated with peritoneal dialysis. Results were consistent with adjustment based on a propensity score model and in sensitivity analyses that used as-treated models and models in which switches in type of dialysis were treated as treatment failures. Results were similar but stronger in analyses that were restricted to patients who were treated only in clinics offering both types of dialysis. LIMITATIONS: Patients were not randomly assigned to their initial type of dialysis. Also, more patients undergoing peritoneal dialysis than hemodialysis switched type of dialysis over time, and the reason for switching was often a consequence of the technique. CONCLUSIONS: The risk for death in patients with ESRD undergoing dialysis depends on dialysis type. Further studies are needed to evaluate a possible survival benefit of a timely change from peritoneal dialysis to hemodialysis.

Cardiovascular Diseases↗

PubMed2002

A comparison of youth referred to psychiatric emergency services: police versus other sources.

Although the presentation of children and adolescents to psychiatric emergency services has been increasing, little is known about the characteristics of these persons, the circumstances surrounding their referral for treatment, or their disposition. This study compares patients referred by police with those referred by others, based on data from a study of 1,779 patients in the Bronx, New York. Logistic regression was used to develop propensity scores for selection of a matched sample of non-police referrals (n = 159) to compare with police referrals (n = 53). Caregivers in police-referred cases were rated as less capable of active treatment involvement, and domestic violence was more likely to occur in their homes. Police referrals had higher substance use in the past month than referrals from other sources, were rated as more symptomatic and dangerous to self and others, had exhibited more assaultive and destructive behavior, and were less likely to be referred to outpatient services.

Adolescent↗

PubMed2002

Does profound hypothermic circulatory arrest improve survival in patients with acute type a aortic dissection?

OBJECTIVE: No evidence exists that profound hypothermic circulatory arrest (PHCA) improves survival or reduces the likelihood of distal aortic reoperation in patients with acute type A aortic dissection. METHODS: Records of 307 patients with acute type A aortic dissection from 1967 to 1999 were retrospectively reviewed. The influence of repair using PHCA (n=121) versus without PHCA (n=186) on death and freedom from distal aortic reoperation was analyzed using multivariable Cox regression models. Propensity score analysis identified a subset of 152 comparable patients in 3 quintiles (QIII-V) in which the effects of PHCA (n=113) versus no PHCA (n=39) were further compared. RESULTS: For all patients, 30-day, 1-year, and 5-year survival estimates were 81+/-2%, 74+/-3%, and 63+/-3% (+/-1 SE). Survival rates and actual freedom from distal aortic reoperation was not significantly different between treatment methods in the entire patient cohort nor in the matched patients in quintiles III-V. Treatment method was not associated with differences in early major complications, late survival, or distal aortic reoperation rates in the entire patient sample or in quintiles III-V. CONCLUSIONS: Aortic repair with or without circulatory arrest was associated with comparable early complications, survival, and distal aortic reoperation rates in patients with acute type A aortic dissection. Despite the lack of concrete evidence favoring the use of PHCA, it does no harm, and most of our group uses PHCA regularly because of its practical technical advantages and theoretical potential merit.

Acute Disease↗

PubMedDate not supplied

Treatment effectiveness of inhaled corticosteroids and leukotriene modifiers for patients with asthma: an analysis from managed care data.

We compared measures of treatment effectiveness when inhaled corticosteroids (ICSs) or leukotriene modifiers (LMs) were used as controller monotherapy for asthma. Asthma patients aged 6-55 years initiating ICS or LM monotherapy between July 1998 and June 1999 (index prescription) were identified using a managed care claims database. Asthma-related hospitalizations, emergency department (ED) visits, and use of short-acting beta-agonists and oral corticosteroids (OCSs) were assessed as proxies for treatment effectiveness. Propensity score was used to adjust for baseline differences between treatment cohorts. The change in the annual rate of claims from the preindex to postindex period for each measure was compared across treatment groups. Logistic regression models of the postindex composite events (hospitalization and/or ED) and OCS use were estimated. Nine hundred sixty patients were initiated on LMs (n = 153) and ICSs (n = 807). The mean annual rate of claims for OCSs increased in the ICS group (0.2) but was unchanged in the LM group (adjusted mean difference in change, 0.2; 95% CI, 0.05-0.4; p = 0.01). The mean annual rate of claims for short-acting beta-agonists increased in both the ICS and LM groups by 1.1 and 0.5, respectively (adjusted mean difference in change, 0.6; 95% CI, -0.06. 1.1; p = 0.08). Similar changes in annualized rates of claims for hospitalizations and ED visits were observed between treatment groups. In logistic regression models, greater odds of postindex OCS use was observed among the ICS group (odds ratio for ICS versus LM = 1.7; 95% CI, 1.04-2.8; p = 0.04). No association between treatment groups and postindex hospitalization and/or ED events was observed. In this managed care population, patients treated with ICSs or LMs had similar measures of treatment effectiveness, as measured by asthma-related health care resource use.

Administration, Inhalation↗

PubMed2003

Rates of serious gastrointestinal events from low dose use of acetylsalicylic acid, acetaminophen, and ibuprofen in patients with osteoarthritis and rheumatoid arthritis.

OBJECTIVE: The frequency of serious gastrointestinal (GI) complications has been quantitated with chronic high doses of nonsteroidal antiinflammatory drugs (NSAID), but risk at lower dosages remains unknown. We examined the prevalence of serious GI events in patients taking aspirin (ASA), acetaminophen (APAP), or ibuprofen (IBU), focusing on low or intermittent use. METHODS: We studied 5692 patients with rheumatoid arthritis (RA) and 3124 patients with osteoarthritis (OA) from 12 databank centers, with 36,262 patient-years of observation, who had taken one of 3 study analgesics, and examined the frequency of serious GI events requiring hospitalization. RESULTS: Treatment groups were of similar ages and severity. As lower doses of study analgesics were taken, serious GI events tended to be less prevalent. In patients taking a study drug alone, without other analgesics or corticosteroids, only one event occurred in over 900 patient-years of exposure, roughly equivalent to background. Rates of GI events while taking APAP with other concurrent therapy or corticosteroids were higher (p < 0.05) than for the other 2 analgesics. In over-the-counter (OTC) doses, there were no significant differences in GI toxicity among analgesics. RA patients tended to have higher rates than OA patients. The rate of GI events was highly dependent on concurrent therapy, increasing 2 to 6-fold in patients taking other analgesics or corticosteroids. Propensity scores for serious GI events were similar across drugs. CONCLUSION: OTC use of ASA, IBU, or APAP carries little risk of serious GI toxicity for most persons. Most serious problems encountered were in higher-risk patients. Given the low rates of events, at low or intermittent dosage without concurrent treatment, these 3 analgesics cannot be distinguished from each other or from background rates of serious GI toxicity.

Acetaminophen↗

PubMed2004

Methodological issues in conducting and analyzing longitudinal observational studies in rheumatoid arthritis.

This article discusses 5 methodological issues that arise in the course of conducting longitudinal observational studies: generalizability, missing data, repeated measures on the same individual, measures taken at varying time points from symptom onset, and assessing the effect of treatment. Methods discussed include general estimating equations and propensity scores. The points are illustrated by examples from the Norfolk Arthritis Register dataset.

Adult↗

PubMedDate not supplied

Comparing the incomparable: hemodialysis versus peritoneal dialysis in observational studies.

A randomized trial comparing survival in hemodialysis and peritoneal dialysis remains a utopian aspiration. Dialysis is still relatively rare on a population basis, and a natural tension exists between desirability and feasibility in terms of quality of evidence. In practice, it is very difficult to perform prospective comparisons with large groups of contemporary representative subjects, and much of the literature comes from retrospective national registries. This article considers several questions to address when trying to compare the outcomes of peritoneal dialysis and hemodialysis. Prognostic similarity at baseline is a fundamental issue. Traditionally, adjustment for known prognostic factors has been used in an attempt to minimize the bias caused by nonrandom treatment assignment. Propensity scores have been suggested to be superior, and matched-case analysis may also be a useful method for comparison. Other questions include, when, in relation to starting dialysis, to start the observation clock; the definition and handling of switches of dialysis therapy; and the decision to censor at transplantation. Finally, comparisons are complicated by hazards ratios that vary over time, and time-segmented analysis is obligatory. Many types of analytical approaches are needed to begin to appreciate outcome disparities between dialysis therapies.

Humans↗

PubMed2005

First time myocardial revascularization in patients younger than 70 years. Single versus double internal mammary artery.

BACKGROUND: We evaluated the early and late outcomes of bilateral internal mammary artery (BIMA) grafting, with or without saphenous vein grafts (SVGs), compared to single internal mammary artery and SVGs in patients < 70 years undergoing first myocardial revascularization. METHODS: From September 1986 to December 1999, 1389 patients underwent first myocardial revascularization using the left internal mammary artery (LIMA) to the left anterior descending artery and SVGs (n = 480) or BIMA (one internal mammary artery on the left anterior descending artery) with or without SVGs (n = 909). Propensity score analysis was used to select 952 (476 of each group) patients with the same preoperative and operative characteristics. Thirty-day outcome and 10-year freedom from all-cause death, cardiac death, acute myocardial infarction (AMI), AMI in a grafted area, redo/percutaneous transluminal coronary angioplasty (PTCA), redo/PTCA in a grafted artery, cardiac events and any events, were evaluated. Follow-up ranged from 3.5 to 16.8 years (mean 8.8+/-4.0 years). RESULTS: Thirty-day mortality was 2.9% in the LIMA group and 1.9% in the BIMA group, p = NS; the BIMA group showed a better 10-year freedom from all-cause death (92.4+/-2.1 vs 87.5+/-3.5%, p = 0.0216), cardiac death (97.4+/-0.9 vs 91.9+/-1.4%, p = 0.0042), AMI (98.7+/-0.5 vs 94.2+/-1.2%, p = 0.0034), AMI in a grafted area (98.9+/-0.5 vs 94.7+/-1.3%, p = 0.0017), cardiac events (95.4+/-1.2 vs 86.8+/-1.8%, p = 0.0026) and any events (88.8+/-2.2 vs 80.7+/-2.1%, p = 0.0124). Cox analysis confirmed that LIMA + SVGs was a risk factor independent of lower freedom from all the above-mentioned events. CONCLUSIONS: Double mammary artery in patients < 70 years who had a first time myocardial revascularization gives a better clinical outcome even 10 years after the operation.

Age Factors↗

PubMed2005

Improved outcomes during cardiac surgery: a multifactorial enhancement of cardiopulmonary bypass techniques.

Patients presenting for cardiac surgery with cardiopulmonary bypass (CPB) are more likely to have pre-existing comorbidities, which has resulted in a steady increase in the risk associated with CPB. The resulting challenge has mandated the optimization of perfusion care. The purpose of this study was to retrospectively evaluate the impact of a number of simultaneous, evidence based perfusion care changes on patient outcome. After Institutional Review Board approval, two groups of patients were compared. The control group (n = 317) included all patients undergoing CPB in a 12-month period preceding a multifaceted change in perfusion techniques. The treatment group (n = 259) included all patients undergoing CPB in the 12-month period after the changes, which included the incorporation of updated continuous blood gas monitoring, biocompatible circuitry, updated centrifugal blood propulsion, continuous autotransfusion technology, new generation myocardial protection instrumentation, plasmapheresis, topical platelet gel application, excluding hetastarch while increasing the use of albumin, viscoelastographic coagulation monitoring, and implementing a quantitative quality improvement program. After univariate analysis, propensity scoring and multiple conditional logistical regression were used to control for demographic, preoperative, operative, and postoperative parameters. Results of the primary endpoints revealed a lower mortality rate in the treatment group (4% vs. 9% [95% confidence interval 1.33, 7.72], p = 0.009), lower transfusion rate (51% vs. 59% [1.00, 2.11], p = 0.048), and lower complication rate (55% vs. 65% [1.06,2.19], p = 0.025) despite having similar predicted mortality (11 [2,22] vs. 11[3,22], p = NS) and other preoperative and operative parameters. The lower mortality rate was concurrent with a trend towards a lower incidence of complications, consistent with the differences in primary outcomes. In conclusion, the patients treated after the implementation of a multifactorial improvement plan using evidence based changes in CPB care had decreased complication and mortality rates.

Aged↗

PubMed2005

Economic impact of extended-release tolterodine versus immediate- and extended-release oxybutynin among commercially insured persons with overactive bladder.

OBJECTIVE: To examine levels of persistence and compliance as well as the economic impact of extended-release tolterodine (tolterodine ER) versus immediate- and extended-release oxybutynin (oxybutynin IR or oxybutynin ER) among commercially-insured patients with overactive bladder (OAB). METHODS: Patients with OAB who initiated tolterodine ER, oxybutynin IR, or oxybutynin ER between January 2001 and December 2002 were identified from the PharMetrics Patient-Centric database; the first medication used in this timeframe was used for treatment group assignment (ie, patients were only in 1 group). Exploratory assessment of persistency and compliance was conducted among all treated patients: subjects were matched 1:1 based on the estimated propensity score for tolterodine ER in remaining analyses. Measures included patient characteristics as well as levels of medication, outpatient and inpatient resource utilization, and costs. Primary comparisons were made descriptively; costs were evaluated using generalized linear models with a gamma distribution and log-link function. RESULTS: Compliance did not differ between tolterodine ER (77.4%) and oxybutynin ER (74.3%), but was lower for oxybutynin IR (60.9%). Mean (+/- standard deviation) duration of therapy was higher for tolterodine ER (139 +/- 132 days) versus oxybutynin ER (115 +/- 122) and oxybutynin IR (60 +/- 85). Totals of 7257 and 5936 matched pairs were available for tolterodine ER versus oxybutynin ER and oxybutynin IR comparisons, respectively. The mean age was 54 years in all groups; the majority was women. Utilization of outpatient and inpatient medical services was consistently lower among tolterodine ER patients in both comparisons. Total costs were slightly lower for tolterodine ER versus oxybutynin ER (dollar 8303 +/- dollar 18 802 vs dollar 8862 +/- dollar 18 684) and oxybutynin IR (dollar 9975 +/- dollar 24860 vs dollar 10521 +/- dollar 22 602); differences were significant after multivariate adjustment. CONCLUSIONS: Use of tolterodine ER results in comparable compliance to oxybutynin ER and longer duration of use relative to either form of oxybutynin. In addition, tolterodine ER may be cost-effective relative to oxybutynin IR or oxybutynin ER among commercially-insured persons with OAB.

Aged↗

PubMedDate not supplied

Safety and efficacy of local administration of contractubex to hypertrophic scars in comparison to corticosteroid treatment. Results of a multicenter, comparative epidemiological cohort study in Germany.

OBJECTIVES: To investigate the safety and efficacy of Contractubex administration to hypertrophic scars in routine out-patient practice and to compare it to corticosteroid treatment. PATIENTS AND METHODS: This was a multicenter, retrospective cohort study, based on 38 randomly selected practices representatively distributed in Germany, including dermatologists and general practitioners. Data from 859 patients fulfilling the inclusion criteria were assessed and analyzed. Of these, 771 patients were eligible for the per protocol treatment with Contractubex (n=555) and corticosteroid (n=216). The safety and efficacy of local administration of Contractubex to hypertrophic scars was compared to corticosteroid treatment. RESULTS: At the end of defined treatment periods (minimum 28 days for local therapy with 1 intralesional corticosteroid application), normalization of the pre-treatment pathological parameters (erythema, pruritus, consistency) of hypertrophic scars was more frequent (42.5%) after Contractubex per protocol treatment as compared to corticosteroid per protocol treatment (22.2%). After adjusting imbalances of baseline characterisics between the treatment groups by the propensity score, the odds ratio was 2.274, demonstrating a significant superiority (p<0.001) of Contractubex treatment as compared to corticosteroid treatment. The time to normalization of erythema, pruritus and consistency was significantly (p=0.034) shorter with Contractubex treatment (median 344 days) than with corticosteroids (median 507 days). No unexpected or severe adverse events occurred in the Contractubex-treated patients. Apart from moderate pruritus (10% Contractubex vs. 1% corticosteroids), adverse events were significantly (p<0.001) more frequent in corticosteroid-treated patients (teleangiectasias 15% vs. 7% Contractubex; cutaneous atrophy of scars 10% vs. 2% Contractubex; cutaneous atrophy of scar surrounding skin tissue 11% vs. 1% Contractubex). CONCLUSION: For the primary aim of this study (assessment of normalization of erythema, pruritus, and consistency of hypertrophic scars) and for time to normalization, local administration of Contractubex was significantly more effective than corticosteroid treatment. Concerning safety, Contractubex treatment was associated with significantly less adverse events (e.g. teleangiectasias, cutaneous atrophy of scars and surrounding skin tissue) than topical corticosteroid application.

Administration, Cutaneous↗