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Outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention in the current era: a report from the Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial.

BACKGROUND: Diabetes portends an adverse prognosis in patients undergoing percutaneous coronary intervention (PCI). Whether improvements in current clinical practice (stents, IIb/IIIa antagonists) have resulted in substantial improvement of these outcomes remains an issue. The aim of this study was to determine the influence of diabetes on 9-month outcomes of patients undergoing PCI in the current era. METHODS AND RESULTS: The 11 482 patients enrolled in the Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial were stratified according to the presence (n=2694) or absence (n=8798) of diabetes. Diabetic patients were older; were more likely to be female; had a higher proportion of congestive failure, hypertension, prior CABG, and unstable angina; and had higher body mass index and lower ejection fraction than nondiabetic patients (P<0.01 for all comparisons). The degree of multivessel disease was similar between the two groups. American College of Cardiology/American Heart Association type C lesions were more common in diabetic patients (17% versus 15%, P<0.01). Angiographic and procedural success rates and in-hospital events were similar between the two groups. The primary end point of death, myocardial infarction, or target vessel revascularization (TVR) was analyzed as time-to-first event within 9 months of the index PCI. After adjusting for certain baseline characteristics, diabetes was independently associated with death at 9 months (relative risk [RR], 1.87; 95% CI, 1.31 to 2.68, P<0.01) and with an increased likelihood of TVR (RR, 1.27; 95% CI, 1.14 to 1.42, P<0.01), as well as the composite end point of death/myocardial infarction/TVR (RR, 1.26; 95% CI, 1.13 to 1.40, P<0.01). CONCLUSIONS: Despite advances in interventional techniques, diabetes remains a significant independent predictor of adverse events in the intermediate term after PCI.

Coronary Angiography↗

Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments)

In order to describe the outcomes of patients hospitalized with an acute exacerbation of severe chronic obstructive pulmonary disease (COPD) and determine the relationship between patient characteristics and length of survival, we studied a prospective cohort of 1,016 adult patients from five hospitals who were admitted with an exacerbation of COPD and a PaCO2 of 50 mm Hg or more. Patient characteristics and acute physiology were determined. Outcomes were evaluated over a 6 mo period. Although only 11% of the patients died during the index hospital stay, the 60-d, 180-d, 1-yr, and 2-yr mortality was high (20%, 33%, 43%, and 49%, respectively). The median cost of the index hospital stay was $7,100 ($4,100 to $16,000; interquartile range). The median length of the index hospital stay was 9 d (5 to 15 d). After discharge, 446 patients were readmitted 754 times in the next 6 mo. At 6 mo, only 26% of the cohort were both alive and able to report a good, very good, or excellent quality of life. Survival time was independently related to severity of illness, body mass index (BMI), age, prior functional status, PaO2/FI(O2), congestive heart failure, serum albumin, and the presence of cor pulmonale. Patients and caregivers should be aware of the likelihood of poor outcomes following hospitalization for exacerbation of COPD associated with hypercarbia.

APACHE↗

Development of a spanish version of the Schwartz Outcome Scale-10: a brief mental health outcome measure.

The lack of culturally appropriate psychometric instruments for the assessment of cognitive and emotional functioning in minority populations has been a concern often discussed in the assessment literature. With the increased focus on the measurement of outcome in mental health treatment, the lack of appropriate instruments for minorities has become readily apparent in this venue as well. We report on the Spanish translation of a brief and reliable measure of psychological health and well-being that has been shown to be sensitive to treatment outcomes. The original and Spanish translated versions of this measure are highly correlated, providing clinicians and organizations with a instrument that can be used for assessment of psychological well-being and treatment outcomes with Hispanic patients.

Acculturation↗

Measuring outcomes in genitourinary medicine: involving service users in the measurement of outcomes.

Recently there has been increased emphasis on the user perspective in health care. At the same time the concern with effective health care is making us look more critically at the outcomes of treatment and other interventions, and the evidence available to us to make sense of effectiveness. This paper addresses the involvement of genitourinary medicine service users in outcome measurement through 3 linked questions: (1) What do we mean by outcomes? (2) What do we mean by users? and (3) What do we mean by involving?

Female Urogenital Diseases↗

Hemodynamic and oxygen transport patterns for outcome prediction, therapeutic goals, and clinical algorithms to improve outcome. Feasibility of artificial intelligence to customize algorithms.

A generalized decision tree or clinical algorithm for treatment of high-risk elective surgical patients was developed from a physiologic model based on empirical data. First, a large data bank was used to do the following: (1) describe temporal hemodynamic and oxygen transport patterns that interrelate cardiac, pulmonary, and tissue perfusion functions in survivors and nonsurvivors; (2) define optimal therapeutic goals based on the supranormal oxygen transport values of high-risk postoperative survivors; (3) compare the relative effectiveness of alternative therapies in a wide variety of clinical and physiologic conditions; and (4) to develop criteria for titration of therapy to the endpoints of the supranormal optimal goals using cardiac index (CI), oxygen delivery (DO2), and oxygen consumption (VO2) as proxy outcome measures. Second, a general purpose algorithm was generated from these data and tested in preoperatively randomized clinical trials of high-risk surgical patients. Improved outcome was demonstrated with this generalized algorithm. The concept that the supranormal values represent compensations that have survival value has been corroborated by several other groups. We now propose a unique approach to refine the generalized algorithm to develop customized algorithms and individualized decision analysis for each patient's unique problems. The present article describes a preliminary evaluation of the feasibility of artificial intelligence techniques to accomplish individualized algorithms that may further improve patient care and outcome.

Algorithms↗

Varieties of long-term outcome among patients in psychoanalysis and long-term psychotherapy. A review of findings in the Stockholm Outcome of Psychoanalysis and Psychotherapy Project (STOPP).

This paper reports the main findings of a large-scale study of subsidized psychoanalysis and long-term psychotherapy. More than 400 people in various phases, before, during and after subsidized psychoanalysis or long-term psychodynamic psychotherapy, were followed up for a period of three years with personal interviews, questionnaires and official statistics. Our analyses revealed progressive improvement the longer patients were in treatment--impressively strong among patients in psychoanalysis--on self-rating measures of symptom distress and morale. Improvement, however, was equally weak in both groups on a self-rating measure of social relations. Dosage factors (treatment duration and session frequency in combination) partly accounted for the outcome differences between those referred to psychoanalysis and those referred to long-term psychotherapy. Attitudes and ideals among therapists and analysts concerning the goals and means of psychotherapy were also associated with patient outcome, although in rather complex ways. A significant part of the outcome differences between patients in psychoanalysis and in psychotherapy could be explained by the adoption, in a large group of therapists, of orthodox psychoanalytic attitudes that seemed to be counterproductive in the practice of psychotherapy but not in psychoanalysis. It is suggested that this effect may be a negative transfer of the psychoanalytic stance into psychotherapeutic practice and that this may be especially pronounced when the attitudes are not backed up by psychoanalytic training.

Adult↗

The Eurocleft study: intercenter study of treatment outcome in patients with complete cleft lip and palate. Part 4: relationship among treatment outcome, patient/parent satisfaction, and the burden of care.

OBJECTIVE: To assess patient/parent satisfaction with the treatment they had received from their respective teams, and to explore interrelationships between satisfaction, objectively rated outcome, and the burden of care. DESIGN: This study reports cross-sectional data as part of the overall longitudinal cohort study reported in the other four papers of this series. SETTING: Multidisciplinary cleft services in Northern Europe. SUBJECTS: 127 consecutively treated 17-year-olds with repaired complete unilateral cleft lip and palate and their parents. MAIN OUTCOME MEASURE: Patient/parent satisfaction. RESULTS: Generally, there was a high level of patient/parent satisfaction. There were no relationships among satisfaction, objectively rated outcomes, and the amount of care. CONCLUSIONS: This study highlights various challenges involved in questionnaire surveys into patient/parent satisfaction, and underlines the need for collective efforts to improve our understanding of this issue.

Adolescent↗

The Glioma Outcomes Project: a resource for measuring and improving glioma outcomes.

The author describes the Glioma Outcomes (GO) Project which conducts outcomes research and develops educational programs to benefit patients who undergo surgery for glioma. In January 1997 an advisory board of neurosurgeons, neurooncologists, and clinical research scientists was formed to establish the policies governing this project and to control the dissemination of aggregate data on clinical practices and outcomes. This voluntary database is designed to 1) guide the development of educational programs to improve the care of patients and 2) provide a mechanism by which physicians can evaluate the impact of their diagnostic and therapeutic decisions in a manner that is timely, confidential, and objective.

Journal Article↗

Documenting outcomes of occupational therapy: the center for outcomes research and education.

This article presents two themes related to the development and implementation of sound outcomes research that emerged from a 3-year dialogue among fellows of the University of Illinois Center for Outcomes Research and Education (CORE). These themes are: that outcomes research needs to be an interrelated multi-method system of investigation, and it should be developed in collaboration with its key stakeholders (consumers and practitioners). Examples from the literature and from a cluster of papers published in this focus issue are used to exemplify the themes.

Evidence-Based Medicine↗

Treatment outcomes of stimulant misusers: one year follow-up results from the national treatment outcome research study (NTORS).

There are substantial gaps in knowledge about treatment outcomes for stimulant misuse. This paper investigates patterns of stimulant use and outcomes of stimulant misusers one year after starting treatment at 54 agencies within United Kingdom national services. In a prospective, longitudinal cohort study of 1,075 drug misusers, 637 were current users of stimulant drugs at intake to treatment. Most of the clients were multiple drug users. Stimulants were the main problem drug for 13% of the sample. The two most frequently used drugs were crack cocaine and amphetamine sulphate. The most frequently reported pattern of stimulant use was among heroin dependent clients who also used stimulants. The clients for whom stimulants were the main problem drug were most likely to approach residential rehabilitation programs for treatment. Overall, the stimulant users showed satisfactory outcomes with marked reductions in substance use and other problem behaviors at follow-up. Many clients with stimulant misuse problems were able to achieve substantial improvements after treatment within existing services.

Adult↗

Comparison of anticoagulation clinic patient outcomes with outcomes from traditional care in a family medicine clinic.

BACKGROUND: Giving patients oral anticoagulation therapy in an ambulatory clinic setting is associated with substantial risk of adverse outcomes leading to emergency department visits and unplanned inpatient admissions. This article describes an effectiveness study conducted in a well-characterized family practice setting that compares anticoagulation outcomes in patients managed by a traditional care model with outcomes obtained with an anticoagulation clinic model. METHODS: All study patients received continuous anticoagulation care at the Family Medicine of Southwest Washington (FMSW) clinic during the 1-year study period. The method was retrospective and used linked record review, including outpatient, inpatient, and emergency department records. Patients were divided into two groups as naturally observed: those treated in the clinic by traditional care compared with those treated in an anticoagulation clinic model. Data analyses compared the two groups in terms of patient demographics, anticoagulation control, and inpatient admissions and emergency department visits that were related to clotting or bleeding events. RESULTS: There were no differences in demographic variables between the anticoagulation clinic and traditional care groups. There was a statistically significant difference in anticoagulation control as measured by international normalized ratio (INR) values. The anticoagulation clinic group had fewer INR values outside the target range, +/- 0.1, than the traditional care group (40.4% vs 47.3% P = .022). The anticoagulation clinic group also had significantly fewer INR tests drawn more than 6 weeks apart than the traditional care group (3.7% vs 8.1% P = .01). There was no statistically significant difference in emergency department visit rates caused by adverse events. Inpatient admission rates for the anticoagulation clinic and traditional care groups were not statistically different; however, they were clinically different (4.7 vs 19.7 admissions per 100 patient years of therapy P = .15). CONCLUSIONS: More anticoagulation patients treated by the anticoagulation clinic model at FMSW received an INR test at least every 6 weeks than those treated by the traditional care model, and more of their INR results were within target range +/- 0.1 when compared with the traditional care model.

Aged↗

[The LORAS project and quality assurance. In four years from input- to outcome-oriented financing in public health. 2: LORAS project outcome parts 1 & 98].

This series of three articles is a summary of the operations, findings and results of the hospital reform projects in the Canton of Zurich, termed LORAS. With the aid of the LORAS project within four years Zurich hospitals have been transformed. Whereas they used to adhere to input-oriented covering of deficits they now operate with outcome-oriented prospective financing of output. Part 1 describes the whole project. Part 2 focuses on the development of outcome-measurement. Part 3 finally describes the implementation of the outcome-measurement in the canton of Zurich.

Hospitals↗

Outcomes of care: the use of conceptual models to "see the forest and the trees" in planning outcomes studies.

Outcomes research provides many opportunities to explore how care activities, care processes, and care systems impact on individuals and health care resources. This article discusses clinical outcomes research and its connection to real-life situations. A model-building approach is presented to clarify the process of outcomes research by acknowledging multiple variables and how they interact. The process is illustrated through a hypothetical model addressing coronary artery disease. The usefulness of using conceptual modeling typing related variables together while creating a framework for increased understanding of key variables and their interaction is discussed.

Coronary Artery Disease↗

Long-term outcomes and predictors of outcomes for patients with juvenile idiopathic arthritis.

Prediction of the long-term outcome for patients with juvenile idiopathic arthritis requires assessment of disability, psychosocial and socioeconomic function. Measures for the first have evolved from Steinbrocker functional classifications to validated self-administered questionnaires. The proportion of patients with severe disability has decreased during the past three decades but significant numbers of patients enter adulthood with some disability detected with the newer measures. Despite careful study, few early predictors of a poor outcome have been identified. The most consistent are early age at onset, persistent fever and thrombocytosis in patients with systemic juvenile idiopathic arthritis. Reports of psychosocial and socioeconomic outcomes are controversial and further analyses of these spheres are required. An increased risk of osteoporosis and osteopenia has been reported in adults with juvenile idiopathic arthritis. The most significant problem faced by patients during adulthood is persistent disease activity as disability, radiographic damage and the risk of osteoporosis all increase with increasing duration of disease.

Adult↗

Prediction of outcome in schizophrenia. III. Five-year outcome and its predictors.

Recent studies of schizophrenia have begun to demonstrate the complex nature of its outcome characteristics and their predictors. However, generalization of findings has been limited by methodological problems such as relatively short-term follow-up the use of retrospective data, or employment of evaluation techniques without demonstrated reliability. This report describes a prospective, five-year follow-up using reliable evaluation techniques to determine whether specific relations between predictors and outcome variables represent behavior patterns persisting over an extended period. Results demonstrate the prognostic importance and specificity of certain predictors over five years. These results support the view that outcome function is comprised of persisting open-linked systems of behavior.

Employment↗

Power calculation for clinical trials when the outcome is a composite ranking of survival and a nonfatal outcome.

In a clinical trial in which mortality occurs and a nonfatal outcome is measured after a fixed duration of follow-up, composite rank scores in which deaths (ranked by survival time) are scored below ranks for the nonfatal outcome have been proposed to test for treatment efficacy. This report derives formulae for calculating power for such a rank test under the conservative assumption that the treatment has a beneficial effect on the nonfatal outcome but no effect on mortality.

Clinical Trials as Topic↗

Directly administered antiretroviral therapy in methadone clinics is associated with improved HIV treatment outcomes, compared with outcomes among concurrent comparison groups.

BACKGROUND: Directly administered antiretroviral therapy (DAART) in methadone clinics has the potential to improve treatment outcomes for human immunodeficiency virus (HIV)-infected injection drug users (IDUs). METHODS: DAART was provided at 3 urban methadone clinics. Eighty-two participants who were initiating or reinitiating highly active antiretroviral therapy (HAART) received supervised doses of therapy at the clinic on the mornings on which they received methadone. Treatment outcomes in the DAART group were compared with outcomes in 3 groups of concurrent comparison patients, who were drawn from the Johns Hopkins HIV Cohort. The concurrent comparison patients were taking HAART on a self-administered basis. The 3 groups of concurrent comparison patients were as follows: patients with a history of IDU who were receiving methadone at the time HAART was used (the IDU-methadone group; 75 patients), patients with a history of IDU who were not receiving methadone at the time that HAART was used (the IDU-nonmethadone group; 244 patients), and patients with no history of IDU (the non-IDU group; 490 patients). RESULTS: At 12 months, 56% of DAART participants achieved an HIV type 1 RNA level <400 copies/mL, compared with 32% of participants in the IDU-methadone group (P=.009), 33% of those in the IDU-nonmethadone group (P=.001), and 44% of those in the non-IDU group (P=.077). The DAART group experienced a median increase in the CD4 cell count of 74 cells/mm3, compared with 21 cells/mm3 in the IDU-methadone group (P=.04), 33 cells/mm3 in the IDU-nonmethadone group (P=.09), and 84 cells/mm3 in the non-IDU group (P=.98). After adjustment for other covariates in a logistic regression model, DAART participants were significantly more likely to achieve viral suppression than were patients in each of the 3 comparison groups. CONCLUSIONS: These results suggest that methadone clinic-based DAART has the potential to provide substantial clinical benefit for HIV-infected IDUs.

Adult↗