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Results for “Propensity Score”

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PubMed2001

Effectiveness of chemotherapy for advanced lung cancer in the elderly: instrumental variable and propensity analysis.

PURPOSE: To compare the effectiveness of chemotherapy given to elderly patients in routine practice for stage IV non-small-cell lung cancer (NSCLC) with the efficacy observed in randomized trials. PATIENTS AND METHODS: We used instrumental variable analysis (IVA) and propensity scores (PS) to simulate the conditions of a randomized trial in a retrospective cohort of patients over age 65 from the Survival, Epidemiology, and End Results (SEER) tumor registry. Geographic variation in chemotherapy use served as the instrument for the IVA analysis, and propensity scores were calculated with a logistic model based on patient disease and sociodemographic characteristics. RESULTS: Among 6,232 elderly patients, the instrumental variable estimate indicated an increase in median survival of 33 days and an improvement in 1-year survival of 9% attributable to chemotherapy. In a Cox regression model, chemotherapy administration was associated with a hazard ratio of 0.81 (95% confidence interval, 0.76 to 0.85). When survival was analyzed separately within propensity score quintiles, the hazard ratios were all similar, ranging from 0.78 to 0.85. These results are comparable with those of a large meta-analysis, which found a hazard ratio of 0.87 in the subgroup of patients over age 65. CONCLUSION: Chemotherapy for stage IV NSCLC seems to have effectiveness for elderly patients and those with comorbid conditions that is similar to the efficacy seen in randomized trials containing mostly younger, highly selected patients. All suitable patients should be given the opportunity to consider palliative chemotherapy for metastatic NSCLC.

Aged↗

PubMed2005

Predictors of revascularization method and long-term outcome of percutaneous coronary intervention or repeat coronary bypass surgery in patients with multivessel coronary disease and previous coronary bypass surgery.

AIMS: The optimal revascularization strategy in patients with symptomatic multivessel coronary artery disease (CAD) and previous coronary artery bypass grafting (CABG) remains unknown. METHODS AND RESULTS: We evaluated all patients with previous CABG undergoing isolated, non-emergency multivessel revascularization between 1 January 1995 and 31 December 2000. The analysis concentrated on the independent predictors of the revascularization method, as well as on long-term mortality and its predictors, after calculating a propensity score for the method of revascularization. There were 2191 patients (1487 with reoperation and 704 with percutaneous coronary intervention, PCI) in the study. The most important factors in choosing reoperation were presence of more diseased or occluded grafts, previous infarction, lower ejection fraction (EF), longer interval from first CABG, and more total occlusions of native arteries, as well as absence of a patent mammary graft. The distribution of the propensity score was skewed towards the two extremes. At 5 years, the unadjusted cumulative survival was 79.5% for CABG and 75.3% for PCI, P=0.008. After adjustment for the propensity score for PCI vs. CABG, PCI was associated with a hazard ratio of 1.47 (0.94-2.28), P=0.09. The most powerful predictors of mortality were higher age and lower EF. CONCLUSION: The choice of the revascularization method in patients with previous CABG is dictated mostly by anatomical considerations and less by clinical characteristics. In contrast, clinical characteristics predominantly affect long-term outcome, whereas the method of revascularization has a limited effect. A randomized clinical trial addressing this important segment of the population with ischaemic heart disease is warranted.

Age Distribution↗

PubMed2005

Surgical revascularization versus amputation for peripheral vascular disease in dialysis patients: a cohort study.

BACKGROUND: Surgical treatment of peripheral vascular disease (PVD) in dialysis patients is controversial. METHODS: We examined the post-operative morbidity and mortality of surgical revascularization or amputation for PVD in a retrospective analysis of United States Renal Data System. Propensity scores for undergoing amputation were derived from a multivariable logistic regression model of amputation. RESULTS: Of the Medicare patients initiated on dialysis from Jan 1, 1995 to Dec 31, 1999, patients underwent surgical revascularization (n = 1,896) or amputation (n = 2,046) in the first 6 months following initiation of dialysis were studied. In the logistic regression model, compared to claudication, presence of gangrene had a strong association with amputation [odds ratio (OR) 19.0, 95% CI (confidence interval) 13.86-25.95]. The odds of dying within 30 days and within 1 year were higher (30 day OR: 1.85, 95% CI: 1.45-2.36; 1 yr OR: 1.46, 95% CI: 1.25-1.71) in the amputation group in logistic regression model adjusted for propensity scores and other baseline factors. Amputation was associated with increased odds of death in patients with low likelihood of amputation (< 33rd percentile of propensity score) and moderate likelihood of amputation (33rd to 66th percentile) but not in high likelihood group (> 66th percentile). The number of hospital days in the amputation and revascularization groups was not different. CONCLUSION: Amputation might be associated with higher mortality in dialysis patients. Where feasible, revascularization might be preferable over amputation in dialysis patients.

Aged↗

PubMed2006

Highly active antiretroviral therapy and hospital readmission: comparison of a matched cohort.

BACKGROUND: Despite the known efficacy of highly active antiretroviral therapy (HAART), a large proportion of potentially-eligible HIV-infected patients do not access, and may stand to benefit from this treatment. In order to quantify these benefits in terms of reductions in hospitalizations and hospitalization costs, we sought to determine the impact of HAART on hospital readmission among HIV-infected patients hospitalized at St. Paul's Hospital (SPH) in Vancouver, BC, Canada. METHODS: All patients admitted to a specialized HIV/AIDS ward at SPH (Apr. 1997-Oct. 2002) were selected and classified as being on HAART or not on HAART based upon their initial admission. Patients were then matched by their propensity scores, which were calculated based on patients' sociodemographics such as age, gender, injection drug use (IDU) status, and AIDS indication, and followed up for one year. Multivariate logistic regression was used to estimate the difference in the odds of hospital readmission between patients on and not on HAART. RESULTS: Out of a total 1084 patients admitted to the HIV/AIDS ward between 1997 and 2002, 662 were matched according to their propensity score; 331 patients each on and not on HAART. Multivariate logistic regression revealed that patients on HAART had lower odds of AIDS hospital readmission (OR, 0.61; 95% CI, 0.42-0.89) compared to patients not on HAART. Odds of readmission among patients on HAART were also significantly lower for non-IDU related readmission (OR, 0.73; 95% CI, 0.53-0.99) and overall readmission (OR, 0.72; 95% CI, 0.53-0.98). CONCLUSION: Propensity score matching allowed us to reliably estimate the association between exposure (on or not on HAART) and outcome (readmitted to hospital). We found that HIV-infected patients who were potentially eligible for, but not on HAART had higher odds of being readmitted to hospital compared to those on HAART. Given the low level of uptake (31%) of HAART observed in our pre-matched hospitalized cohort, a large potential to achieve clinical benefits, reduce hospitalization costs and possibly slow disease progression from improved HAART uptake still exists.

Adult↗

PubMed2001

A propensity analysis of cigarette smoking and mortality with consideration of the effects of alcohol.

Although it is well established that cigarette smoking causes excess mortality, the extent of the increased risk has been challenged because self-selection biases and confounding factors may not have been adequately accounted for in prior studies. We therefore performed a propensity analysis on a population-based cohort. A logistic regression model was used to generate a propensity score for current smoking in 6,099 adults (mean age 46 years, 54% men, 36% current smokers) participating in the National Heart Lung and Blood Institute's (NHLBI) Lipid Research Clinic Prevalence Study. During 12 years of follow-up, 513 subjects (8%) died. After adjusting for age, current smoking was strongly associated with death (compared with never and former smokers, relative risk [RR] 2.69, 95% confidence interval [CI] 1.98 to 0.64, p <0.0001 and RR 1.79, 95% CI 1.26 to 2.55, p = 0.001, respectively). After adjusting for a propensity score based on 27 covariates and the covariates themselves, current smoking remained strongly and independently predictive of excessive death risk in smokers compared with never and former smokers (adjusted RR 2.96, 95% CI 2.16 to 4.05, p <0.0001 and adjusted RR 1.87, 95% CI 1.31 to 2.67, p = 0.0006, respectively). Although smokers were more likely to also drink alcohol, an interaction was noted, whereby, after adjustment for propensity score and other covariates, current smoking was associated with a moderately strong increase in mortality among drinkers (adjusted RR 2.00, 95% CI 1.42 to 2.82, p <0.0001), but was also associated with a markedly increased death risk among nondrinkers (adjusted RR 4.74, 95% CI 3.24 to 6.92, p <0.0001). The independent association of smoking with death even after a rigorous propensity analysis argues that it is highly unlikely that the link between smoking and mortality is materially biased or confounded.

Adult↗

PubMed2005

Reduction of the efficacy of methotrexate by the use of folic acid: post hoc analysis from two randomized controlled studies.

OBJECTIVE: To examine the effect of folic acid on the efficacy of methotrexate (MTX) treatment in rheumatoid arthritis (RA) at 12 months in 2 phase III randomized controlled trials (RCTs) of leflunomide in which MTX was used as a comparator. METHODS: Analyses were restricted to patients randomized to receive MTX who had rheumatoid factor data. The US study recruited 482 patients with active RA; 179 received at least 1 dose of MTX, and all were mandated to receive 1 mg of oral folic acid once or twice daily. The multinational European study recruited 999 patients with active RA; 489 received at least 1 dose of MTX, and oral folic acid was not required, although 50 received folate after developing an adverse event. Because of similar entry criteria for both studies, the data for patients with available primary outcome data at week 52 were pooled (n = 668), and the patients were grouped by folic acid use (n = 225) and nonuse (n = 443). To account for the significant between-study differences in the MTX groups, baseline covariates were adjusted using propensity scores so that folic acid users could be matched with nonusers. This allowed for a comparison of differences in American College of Rheumatology (ACR) 20% improvement criteria at week 52. RESULTS: At study entry, non-folic acid users had a significantly lower mean body weight, shorter mean RA duration, and higher mean disease activity (measured by joint counts, patient's and physician's global assessments, and acute-phase reactant levels). The mean MTX dosage at week 52 was similar in the 2 RCTs. Using propensity score matching techniques, the proportion of patients achieving an ACR 20% response at week 52 averaged 17% higher in the non-folic acid group than in the folic acid group (range 15-21%). Similarly, the proportion of patients achieving ACR 50% and ACR 70% responses averaged 14% (range 12-16%) and 12% (range 9-14%) higher, respectively, in the non-folic acid group. Adverse events were reported in 93% of US study patients and 94% of the multinational study patients. Elevated liver transaminase levels (above the upper limit of normal) were reported in 29% of the US study patients (majority receiving folic acid) and 62% of the multinational study patients (majority not receiving folic acid). CONCLUSION: After using propensity scores to adjust for differences in the baseline characteristics of folic acid users and non-folic acid users, 9-21% fewer MTX-treated RA patients taking folic acid had ACR 20%, 50%, or 70% improvement at 52 weeks compared with those who did not receive folic acid in the 2 phase III RA clinical trials. As a post hoc analysis, the results of this data analysis should be considered "hypothesis generating" and an impetus for future studies regarding the effects of folic acid on the efficacy of MTX in RA.

Adult↗

PubMed2002

Multivariate analyses to assess treatment effectiveness in advanced head and neck cancer.

OBJECTIVE: To assess relative benefit of combined radiotherapy and surgery over single-modality treatment for advanced-stage squamous cell carcinoma of the aerodigestive tract by means of several multivariable analyses to control for patient variables. DESIGN: Medical chart review. SETTING: University medical center. PATIENTS AND METHODS: The study included 532 patients receiving initial therapy between January 1, 1980, and December 31, 1989. Three multivariate techniques (multiple logistic regression, propensity score stratification, and conjunctive consolidation) were used to compare outcomes for treatment groups. MAIN OUTCOME MEASURE: Five-year survival. RESULTS: Survival for radiation, surgery, and combined treatment groups were 24%, 40%, and 46%, respectively. With the use of multiple logistic regression to control patient variables, the radiation group had a significantly lower survival than the combined therapy group (risk ratio, 2.24; 95% confidence interval, 1.32-3.80), while there was no statistical difference for the surgery group compared with the combined therapy group (risk ratio, 1.26; 95% confidence interval, 0.78-2.03). When analyzed by propensity score, 5-year survival was higher in each quintile for the combined therapy group than for the group who received radiation alone (P =.002). There was no significant difference in survival between the surgery and combined treatment groups (P =.25). Conjunctive consolidation was used to create a clinical staging system to compare outcomes across treatment groups. In each clinical severity stage, radiation alone had a lower survival than combined therapy (P =.001), while no statistical difference was noted between surgery and combined therapy (P =.50). CONCLUSIONS: All 3 statistical techniques showed a significantly lower survival for patients treated with radiation alone vs combined therapy. No significant difference was noted between surgery and combined therapy. Propensity score analysis and conjunctive consolidation are useful techniques to control prognostic variables in cancer database studies and should be used in future outcome studies that address more current treatment dilemmas in head and neck oncology.

Aged↗

PubMed2007

On modelling response propensity for dwelling unit (DU) level non-response adjustment in the Medical Expenditure Panel Survey (MEPS).

Non-response is a common problem in household sample surveys. The Medical Expenditure Panel Survey (MEPS), sponsored by the Agency for Healthcare Research and Quality (AHRQ), is a complex national probability sample survey. The survey is designed to produce annual national and regional estimates of health-care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian non-institutionalized population. The MEPS sample is a sub-sample of respondents to the prior year's National Health Interview Survey (NHIS) conducted by the National Center for Health Statistics (NCHS). The MEPS, like most sample surveys, experiences unit, or total, non-response despite intensive efforts to maximize response rates. This paper summarizes research on comparing alternative approaches for modelling response propensity to compensate for dwelling unit (DU), i.e. household level non-response in the MEPS.Non-response in sample surveys is usually compensated for by some form of weighting adjustment to reduce the bias in survey estimates. To compensate for potential bias in survey estimates in the MEPS, two separate non-response adjustments are carried out. The first is an adjustment for DU level non-response at the round one interview to account for non-response among those households subsampled from NHIS for the MEPS. The second non-response adjustment is a person level adjustment to compensate for attrition across the five rounds of data collection. This paper deals only with the DU level non-response adjustment. Currently, the categorical search tree algorithm method, the chi-squared automatic interaction detector (CHAID), is used to model the response probability at the DU level and to create the non-response adjustment cells. In this study, we investigate an alternative approach, i.e. logistic regression to model the response probability. Main effects models and models with interaction terms are both evaluated. We further examine inclusion of the base weights as a covariate in the logistic models. We compare variability of weights of the two alternative response propensity approaches as well as direct use of propensity scores. The logistic regression approaches produce results similar to CHAID; however, using propensity scores from logistic models with interaction terms to form five classification groups for weight adjustment appears to perform best in terms of limiting variability and bias. Published in 2007 by John Wiley & Sons, Ltd.

Family Characteristics↗

PubMed2005

A matched-cohort study of selected clinical and utilization outcomes for an asthma care support program.

Estimating the economic and clinical impact of asthma disease management programs traditionally has relied on non-experimental designs and employed matching or stratification methods with limited success. Selecting similar comparison subjects is problematic since subjects must be compared across numerous pretreatment factors. In cases where treatment and comparison subjects differ greatly on observed characteristics, conclusions may be particularly sensitive to an incorrectly specified model used for matching. A propensity score method constructs matched samples of treated-control pairs, addresses program selection bias, and reduces bias in estimates of treatment effects. To investigate the program effects of an asthma care support program delivered to high-risk asthmatics (persons with a previous inpatient admission, emergency department [ED] visit, or observation visit), we conducted a matched-cohort study on 196 participants. Using administrative claims data and selected clinical indicators, we analyzed hospitalization, ED, and physician office visit rates to estimate effects of program enrollment. Total hospitalizations, asthma-related hospitalizations, bed days, and ED visits for participants were lower and statistically different from that of the matched-cohort group during the program period, suggesting the beneficial effects of monitoring, education, and counseling activities for participants. Where controlled randomized clinical trials cannot be performed because of ethical, cost, or feasibility issues, the use of propensity scores provides an alternative for estimating treatment effects using observational data. This study employs a propensity score-matching methodology to select a subset of comparison units most comparable to treatment units, and documents the beneficial outcomes of participation in an asthma care support program.

Adolescent↗

PubMed2007

Tracheostomy does not improve the outcome of patients requiring prolonged mechanical ventilation: a propensity analysis.

OBJECTIVE: To examine the association between the performance of a tracheostomy and intensive care unit and postintensive care unit mortality, controlling for treatment selection bias and confounding variables. DESIGN: Prospective, observational, cohort study. SETTING: Twelve French medical or surgical intensive care units. PATIENTS: Unselected patients requiring mechanical ventilation for > or =48 hrs enrolled between 1997 and 2004. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Two models of propensity scores for tracheostomy were built using multivariate logistic regression. After matching on these propensity scores, the association of tracheostomy with outcomes was assessed using multivariate conditional logistic regression. Results obtained with the two models were compared. Of the 2,186 patients included, 177 (8.1%) received a tracheostomy. Both models led to similar results. Tracheostomy did not improve intensive care unit survival (model 1: odds ratio, 0.94; 95% confidence interval, 0.63-1.39; p = .74; model 2: odds ratio, 1.12; 95% confidence interval, 0.75-1.67; p = .59). There was no difference whether tracheostomy was performed early (within 7 days of ventilation) or late (after 7 days of ventilation). In patients discharged free from mechanical ventilation, tracheostomy was associated with increased postintensive care unit mortality when the tracheostomy tube was left in place (model 1: odds ratio, 3.73; 95% confidence interval, 1.41-9.83; p = .008; model 2: odds ratio, 4.63; 95% confidence interval, 1.68-12.72, p = .003). CONCLUSIONS: Tracheostomy does not seem to reduce intensive care unit mortality when performed in unselected patients but may represent a burden after intensive care unit discharge.

APACHE↗

PubMed2003

Multiple imputation methods for longitudinal blood pressure measurements from the Framingham Heart Study.

Missing data are a great concern in longitudinal studies, because few subjects will have complete data and missingness could be an indicator of an adverse outcome. Analyses that exclude potentially informative observations due to missing data can be inefficient or biased. To assess the extent of these problems in the context of genetic analyses, we compared case-wise deletion to two multiple imputation methods available in the popular SAS package, the propensity score and regression methods. For both the real and simulated data sets, the propensity score and regression methods produced results similar to case-wise deletion. However, for the simulated data, the estimates of heritability for case-wise deletion and the two multiple imputation methods were much lower than for the complete data. This suggests that if missingness patterns are correlated within families, then imputation methods that do not allow this correlation can yield biased results.

Adult↗

PubMed2003

Myocardial revascularization with and without cardiopulmonary bypass: advantages, disadvantages and similarities.

OBJECTIVES: Off-pump coronary artery bypass surgery is becoming increasingly popular although its effectiveness remains controversial. Our goal was to investigate the effectiveness of on-pump and off-pump coronary artery bypass surgery on early (30 days) and long-term (5 years) clinical outcome in two groups of patients selected using propensity scores. METHODS: From November 1994 to December 2001, 4381 patients underwent isolated coronary surgery. Applying propensity score matching, 1922 patients were selected (off-pump n=961, on-pump n=961). RESULTS: Stepwise logistic regression analysis showed that the use of cardiopulmonary bypass was an independent predictor for early death, cerebral vascular accident, early negative primary endpoints (ENPEP), and early major events (EME). Five years freedom from both events was similar in the two groups. However, freedom from acute myocardial infarction (AMI) in grafted areas was higher in the off-pump than in the on-pump patients, a possible explanation being the lower postoperative creatine kinase myocardial band (CKMB) release. Grouping all patients according to CKMB peak release also showed that patients with normal release values had higher freedom from all cardiac events investigated. A subgroup analysis of 59 patients converted from off-pump to on-pump showed higher early mortality, ENPEP, and EME. Conversion, however, did not affect late clinical outcome. CONCLUSIONS: These results suggest that off-pump surgery reduces early mortality and morbidity. Conversion to on-pump carries high in-hospital mortality and morbidity. Long-term clinical outcome is similar in the two groups; however, off-pump patients seemed to have a higher freedom from AMI in the grafted area which might be related to the lower CKMB peak release when compared with patients undergoing on-pump surgery.

Aged↗

PubMed2005

Health status and quality of life reported by incident patients after 1 year on haemodialysis or peritoneal dialysis.

BACKGROUND: It has been suggested that there are no large differences in the quality of life of incident patients starting on haemodialysis (HD) and peritoneal dialysis (PD), but few studies have addressed this issue. METHODS: Association of modality with incident patients' health status and quality of life scores was investigated with propensity score (PS) analysis and also with traditional multivariable regression analyses. We compared patient reported health status and quality of life scores after 1 year of therapy in 455 HD and 413 PD patients who participated in a national study, stayed on the same modality and had complete socio-demographic and clinical information needed to create a PS indicating their expected probability of starting on PD. RESULTS: One year scores on the majority of health status and quality of life measures were not significantly different for HD and PD patients within propensity-matched quintiles. PD patients' scores were higher than HD patients' scores on effects of kidney disease, burden of kidney disease, staff encouragement and satisfaction with care in some quintiles, and traditional regression analyses confirmed that dialysis modality was associated with patients' scores on these variables. CONCLUSIONS: This study provides support for making the choice of PD more widely available as an option to patients initiating chronic dialysis therapy. Patient lifestyle opportunities associated with use of PD, a home-based and self-care therapy, may also apply to home-based HD or in-centre self-care HD. Patients' expectations regarding treatment and their attitudes toward management of their health may interact with treatment modality to shape patient-reported experience on dialysis; this is an important focus for future studies.

Adult↗

PubMed2007

Population based study of hormonal therapy and survival in men with metastatic prostate cancer.

PURPOSE: Although the palliative benefits of hormonal therapy for metastatic prostate cancer are widely recognized, little information is available regarding the effect of hormonal therapy on cancer specific and overall survival, and the types of patients who might benefit the most or least from hormonal therapy. MATERIALS AND METHODS: Prostate cancer specific and overall survival according to hormonal therapy use was determined by the Kaplan-Meier method in 6,098 men 65 years or older diagnosed with metastatic prostate cancer in 1991 to 1999 who were identified through the population based Surveillance, Epidemiology, and End Results, and Medicare linked database. Cox proportional hazards and propensity score methods were used to adjust for potential confounders, such as disease status and patient comorbidity. RESULTS: Propensity score adjusted median overall survival was 26 months in men who received hormonal therapy compared with 13 months in those who did not (HR 0.66, 95% CI 0.17-0.70, p <0.0001). The benefit of hormonal therapy was observed across all comorbidity strata and races. Effects were most evident in patients with poorly differentiated cancer (cancer specific mortality in favor of treatment HR 0.60, 95% CI 0.53-0.69, p <0.001). Benefit was not found in patients with well differentiated cancer (cancer specific mortality in favor of no treatment HR 1.92, 95% CI 0.90-4.10, p = 0.09). CONCLUSIONS: Hormonal therapy is associated with improved prostate cancer specific and overall survival in men with poorly differentiated cancer. Improved survival does not appear evident in men with well differentiated disease.

Aged↗

PubMed2004

Diuretics and mortality in acute renal failure.

OBJECTIVE: According to recent research, diuretics may increase mortality in acute renal failure patients. The administration of diuretics in such patients has been discouraged. Our objective was to determine the impact of diuretics on the mortality rate of critically ill patients with acute renal failure. DESIGN: Prospective, multiple-center, multinational epidemiologic study. SETTING: Intensive care units from 54 centers and 23 countries. PATIENTS: Patients were 1,743 consecutive patients who either were treated with renal replacement therapy or fulfilled predefined criteria for acute renal failure. INTERVENTIONS: Three distinct multivariate models were developed to assess the relationship between diuretic use and subsequent mortality: a) a propensity score adjusted multivariate model containing terms previously identified to be important predictors of outcome; b) a new propensity score adjusted multivariate model; and c) a multivariate model developed using standard methods, compensating for collinearity. MEASUREMENTS AND MAIN RESULTS: Approximately 70% of patients were treated with diuretics at study inclusion. Mean age was 68 and mean Simplified Acute Physiology Score II was 47. Severe sepsis/septic shock (43.8%), major surgery (39.1), low cardiac output (29.7), and hypovolemia (28.2%) were the most common conditions associated with the development of acute renal failure. Furosemide was the most common diuretic used (98.3%). Combination therapy was used in 98 patients only. In all three models, diuretic use was not associated with a significantly increased risk of mortality. CONCLUSIONS: Diuretics are commonly prescribed in critically ill patients with acute renal failure, and their use is not associated with higher mortality. There is full equipoise for a randomized controlled trial of diuretics in critically ill patients with renal dysfunction.

Acute Kidney Injury↗

PubMedDate not supplied

Effectiveness of recombinant human platelet-derived growth factor for the treatment of diabetic neuropathic foot ulcers.

The goal of this study was to estimate the effectiveness in actual clinical practice of recombinant human platelet-derived growth factor (rhPDGF) for the treatment of diabetic neuropathic foot ulcer (DNFU). Previously published pivotal trials have shown that by the 20th week of care 35 percent more ulcers healed in the group randomized to receive rhPDGF than those who did not receive rhPDGF (i.e., a relative risk [RR] of about 1.35). This represents an estimate of the efficacy of rhPDGF under the tightly controlled conditions of randomized clinical trials. Treatment effectiveness under standard clinical practice was estimated in a retrospective cohort study, controlling for treatment selection bias using propensity scores. We noted 24,898 individuals with a DNFU, of whom 9.6 percent received rhPDGF. We successfully created a propensity score model that evenly balanced many wound characteristics between those who received rhPDGF and those who did not. We created five groups, which varied from those least likely to receive rhPDGF to those most likely to receive rhPDGF. The RR, controlling for the propensity, to receive rhPDGF for a healed wound after treatment with rhPDGF as compared with standard care was 1.32 (1.22, 1.38). With respect to amputation, the RR for undergoing amputation after receiving rhPDGF was 0.65 (0.54, 0.78) as compared with those who did not receive rhPDGF. Within the limitations of our study, rhPDGF is more effective than standard therapy in both helping a wound to heal and preventing amputation, and its effect is similar to the efficacy estimates from previously published randomized controlled trials.

Aged↗

PubMed2006

Gemcitabine-cisplatin chemotherapy before lung resection: a case-matched analysis of early outcome.

BACKGROUND: The objective of the present study was to assess whether neoadjuvant chemotherapy with gemcitabine and cisplatin was associated with an increased incidence of morbidity and mortality after major lung resection for lung cancer. METHODS: We analyzed 570 patients who underwent lobectomy or pneumonectomy for nonsmall-cell lung cancer at our institution from January 2000 through June 2005. Of these, 70 patients underwent three cycles of gemcitabine-cisplatin chemotherapy before operation for locally advanced disease. Propensity scores were constructed to match those patients undergoing neoadjuvant chemotherapy and lung resection with those undergoing surgery alone. The propensity score analysis yielded two groups of 70 well-matched pairs that were compared in terms of baseline characteristics and early outcome (morbidity, mortality, length of postoperative stay, intensive care unit admission). RESULTS: The two case-matched groups had similar morbidity (p = 0.8), mortality (p = 0.4), perioperative blood transfusions (p = 0.8) and intensive care unit admission rates (p = 0.8). Likewise, the length of postoperative stay did not differ between the groups (p = 0.9). CONCLUSIONS: Gemcitabin-cisplatin neoadjuvant chemotherapy appears to be safe before major lung resection. This finding warrants its use for efficacy studies of locally advanced and even early-stage lung cancer.

Aged↗

PubMed2005

Comparison of results of carotid stenting followed by open heart surgery versus combined carotid endarterectomy and open heart surgery (coronary bypass with or without another procedure).

We compared a novel strategy of carotid stenting (CS) followed by open heart surgery (OHS) to the combined carotid endarterectomy (CEA) and the OHS approach in patients requiring coronary and carotid revascularization. Between 1997 and 2002, CS as a prelude to OHS was performed in 56 patients, and 111 patients underwent combined CEA+OHS. Adverse events included stroke, myocardial infarction (MI), death, and their combinations. At baseline, the CS+OHS group had more unstable/severe angina (52% vs 27%, p = 0.002), severe left ventricular dysfunction (20% vs 9%, p = 0.05), symptomatic carotid disease (46% vs 23%, p = 0.002), and the need for repeat OHS (32% vs 9%, p = 0.0002). Severe contralateral carotid disease was more prevalent in the CEA+OHS group (28% vs 11%, p = 0.01). At 30 days, CS+OHS patients had a significantly lower incidence of stroke or MI (5% vs 19%, p = 0.02). A propensity score was created for each patient to account for baseline differences. In a final logistic regression model that included the propensity score, CS+OHS was associated with a trend toward reduced stroke or MI (odds ratio 0.26, 95% confidence interval 0.06 to 1.09, p = 0.06) and reduced death, stroke, or MI (odds ratio 0.40, 95% confidence interval 0.12 to 1.27, p = 0.12). In conclusion, despite a higher baseline risk profile, patients who underwent CS+OHS had significantly fewer adverse events than those undergoing CEA+OHS. CS may be a safer carotid revascularization option for this challenging patient population.

Aged↗