Patient Characteristic Variables Research Articles

Increasing Use of Less-Invasive Hemodynamic Monitoring in 3 Specialty Surgical Intensive Care Units

Less-invasive hemodynamic monitoring (eg, esophageal doppler monitoring [EDM] and arterial pressure contour analysis, FloTrac) is increasingly used as an alternative to pulmonary artery catheters (PACs) in critically ill intensive care unit (ICU). The decrease in use of PACs is not associated with increased mortality. Five-year retrospective review of 1894 hemodynamically monitored patients admitted to 3 surgical ICUs in a university-affiliate, tertiary care urban hospital. Data included the number of admissions, diagnosis-related group discharge case mix, length of stay, insertion of monitoring devices (PAC, EDM, and FloTrac probes), administered intravenous vasoactive agents (β-predominant agonists--dobutamine, epinephrine, and dopamine; vasopressors--norepinephrine and phenylephrine), and mortality. Data from hospital administrative databases were compiled to create patient characteristic and monitoring variables across a 5-year time period, 2005 to 2009 inclusive. Chi-square for independent proportions, 1-way analysis of variance, and Kruskal-Wallis tests were used; tests for trend were conducted. An α level of .05 was considered significant. Statistical Package for the Social Sciences v14 was used for all statistical testing. There was a significant change in the type of hemodynamic monitors inserted in 2 of the 3 surgical ICUs (in the general surgery and neurointensive care but not in the cardiac ICU) from PACs to less-invasive devices (FloTrac or EDM) during the 5-year study period (P < .001). There was no change in mortality rate over the time period (P = .492). There was an overall increase in the proportion of monitored patients who received intravenous vasoactive agents (P < .001) with a progressive shift from β-agonists to vasopressors (P < .002). Multivariate analyses indicated that age, case mix, and use of vasoactive agents were all independent predictors of inhospital mortality (P = .001) but that type of monitoring was not (P = .638). In a 5-year period, the decreased insertions of PACs were replaced by increased utilization of less-invasive hemodynamic monitoring devices. This change in practice did not adversely impact mortality.

DO DIAGNOSIS‐RELATED GROUPS APPROPRIATELY EXPLAIN VARIATIONS IN COSTS AND LENGTH OF STAY OF HIP REPLACEMENT? A COMPARATIVE ASSESSMENT OF DRG SYSTEMS ACROSS 10 EUROPEAN COUNTRIES

This paper assesses the variations in costs and length of stay for hip replacement cases in Austria, England, Estonia, Finland, France, Germany, Ireland, Poland, Spain and Sweden and examines the ability of national diagnosis-related group (DRG) systems to explain the variation in resource use against a set of patient characteristic and treatment specific variables. In total, 195,810 cases clustered in 712 hospitals were analyzed using OLS fixed effects models for cost data (n=125,698) and negative binominal models for length-of-stay data (n=70,112). The number of DRGs differs widely across the 10 European countries (range: 2-14). Underlying this wide range is a different use of classification variables, especially secondary diagnoses and treatment options are considered to a different extent. In six countries, a standard set of patient characteristics and treatment variables explain the variation in costs or length of stay better than the DRG variables. This raises questions about the adequacy of the countries' DRG system or the lack of specific criteria, which could be used as classification variables.

Comparing treatment effects between propensity scores and randomized controlled trials: improving conduct and reporting

This editorial refers to ‘Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndrome’†, by I.J. Dahabreh et al. , on page 1893 Evaluating the effectiveness of a therapeutic intervention is ideally carried out in the setting of a randomized controlled trial (RCT). Patients are randomly allocated to the experimental and control groups ensuring that observed, pre-treatment key prognostic characteristics, but also unobserved patient characteristics, are balanced between the treatment groups, minimizing the variability in patient characteristics. Providing a sufficient number of patients have been randomized, this balance in observed and unobserved pre-treatment characteristics between the groups enables unbiased conclusions about the treatment effect to be drawn. There may, however, be instances where randomization is not possible due to, for example, ethical reasons (e.g. emergency surgery,1 transplantation2) or because it is impractical (e.g. rare events, financial reasons). When it is not possible to conduct an adequately powered RCT, observational studies are often carried out to examine and infer treatment effects. In addition, treatment effects observed in RCTs that involve highly selective populations are often examined in different patient populations and settings in observational studies. However, in observational studies, investigators have no control over treatment assignment, which is often part of a patient's routine medical care. In these instances, it is likely that potentially large systematic differences (typically confounding by indication) in observed patient characteristics could lead to large, biased, and ultimately misleading estimates of treatment effect. Propensity scores are increasingly being used to reduce the impact …

Supportive Decision Making at the Point of Care

Variations in nursing care have been observed, affecting patient outcomes and quality of care. Case-based reasoners that benchmark for patient indicators can reduce variation through decision support. This study evaluated and validated a case-based reasoning application to establish benchmarks for nursing-sensitive patient outcomes of pain, fatigue, and toilet use, using patient characteristic variables for generating similar cases. Three graduate nursing students participated. Each ranked 25 patient cases using demographics of age, sex, diagnosis, and comorbidities against 10 patients from a database. Participant judgments of case similarity were compared with the case-based reasoning system. Feature weights for each indicator were adjusted to make the case-based reasoning system's similarity ranking correspond more closely to participant judgment. Small differences were noted between initial weights and weights generated from participants. For example, initial weight for comorbidities was 0.35, whereas weights generated by participants for pain, fatigue, and toilet use were 0.49, 0.42, and 0.48, respectively. For the same outcomes, the initial weight for sex was 0.15, but weights generated by the participants were 0.025, 0.002, and 0.000, respectively. Refinement of the case-based reasoning tool established valid benchmarks for patient outcomes in relation to participants and assisted in point-of-care decision making.

Usefulness of the Duke Sudden Cardiac Death Risk Score for Predicting Sudden Cardiac Death in Patients With Angiographic (>75% Narrowing) Coronary Artery Disease

The currently available sudden cardiac death (SCD) risk prediction tools fail to identify most at-risk patients and cannot delineate a specific patient's SCD risk. We sought to develop a tool to improve the risk stratification of patients with coronary artery disease. Clinical, demographic, and angiographic characteristics were evaluated among 37,258 patients who had undergone coronary angiography from January 1, 1985 to May 31, 2005, and who were found to have at least one native coronary artery stenosis of > or =75%. After a median follow-up of 6.2 years, SCD had occurred in 1,568 patients, 14,078 patients had died from other causes, and 21,612 patients remained alive. A Cox proportional hazards model identified 10 independent patient characteristic variables significantly associated with SCD. A simplified model accounting for 97% of the predictive capacity of the full model included the following 7 variables: depressed left ventricular ejection fraction, number of diseased coronary arteries, diabetes mellitus, hypertension, heart failure, cerebrovascular disease, and tobacco use. The Duke SCD risk score was created from the simplified model to predict the likelihood of SCD among patients with coronary artery disease. It was internally validated with bootstrapping (c-index = 0.75, chi-square = 1,220.8) and externally validated in patients with ischemic cardiomyopathy from the Sudden Cardiac Death Heart Failure Trial (SCD-HeFT) database (c-index = 0.64, chi-square = 14.1). In conclusion, the Duke SCD risk score represents a simple, validated method for predicting the risk of SCD among patients with coronary artery disease and might be useful for directing treatment strategies designed to mitigate the risk of SCD.

Outcome Predictors for Sacroiliac Joint (Lateral Branch) Radiofrequency Denervation

Sacroiliac (SI) joint pain is a challenging condition characterized by limited treatment options. Recently, numerous studies have reported excellent intermediate-term outcomes after lateral-branch radiofrequency (RF) denervation, but these studies are characterized by wide variability in technique, selection criteria, and patient characteristics. The purpose of this study was to determine whether any demographic or clinical variables can be used to predict SI joint RF denervation outcome. Seventy-seven patients with refractory, injection-confirmed SI joint pain underwent SI joint denervation at 2 academic institutions. A composite binary variable "successful" outcome was predefined as greater than 50% reduction in pain lasting at least 6 months coupled with a positive global perceived effect. Secondary outcome measures included Oswestry Disability Index scores, medication reduction, and retention on active duty for soldiers. Factors retrospectively evaluated for their association with outcome included demographic variables, duration of pain, opioid usage, pain referral pattern, physical examination signs, number of blocks and percentage of pain relief after SI joint injection, prognostic lateral-branch blocks, previous surgery, levels lesioned, RF technique, disability status, and coexisting medical conditions. Forty patients (52%) obtained a positive outcome. In multivariate analysis, preprocedure pain intensity, age older than 65 years, and pain radiating below the knee were significant predictors of failure. A trend was noted whereby patients receiving regular opioid therapy were more likely to experience a negative outcome. The use of cooled, rather than conventional RF, was associated with a higher percentage of positive outcomes. Whereas several factors were found to influence outcome, no single clinical variable reliably predicted treatment results. The use of more stringent selection criteria was not associated with better outcomes.

Identifying Amino Acid Substitution Positions Associated with Day 100 Survival in Unrelated Donor Stem Cell Transplant Using Random Forest Analysis

Unrelated donor stem cell transplant (SCT) is a well established treatment option for patients with hematological malignancies. A major barrier to the success of this treatment is donor-recipient HLA mismatch (MM). HLA-A, B, C, and DRB1 MMs have been associated with early and severe acute GvHD and low survival rate. However, the extent and type of HLA MMs that modulate undesirable immune responses remains unclear.The present study examines the effect of HLA MM at amino acid sequence level on day 100 survival (D100S). From 3,855 SCTs facilitated by the NMDP from 1988 to 2004, we selected 2,107 recipients with early- or intermediate-stage ALL, AML, CML, or MDS who were either matched with their donors at HLA-DRB1 but had a single HLA-class I MM at HLA-A (n=179), B (n=88), or C (n=333), or who were matched at HLA-A, B, C, and DRB1 (n=1,507). In this study population, of over 270 amino acid positions in each HLA class I loci, 59 amino acid positions had at least one amino acid substitution (AAS) in HLA-A, 46 positions in HLA-B, and 46 positions in HLA-C, for a total of 151 positions in HLA-A, B, and C.A common approach to study the effect of AAS on SCT outcome is to perform separate analyses for individual substitutions (e.g., Kawase et al., Blood , 110: 2235–41, 2007). This approach may be inadequate as SCT outcome is potentially influenced by all AAS positions as well as between-position interactions. However, traditional regression techniques to model between-position interactions are problematic owing to the proliferation of indicator variables required for encoding a large number of highly multilevel unordered categorical covariates (i.e., AAS positions) and attendant interactions. We applied Random Forests (RF) as a screening procedure to identify a small subset of important AAS positions associated with D100S for more thorough statistical analyses.RF is a tree-based method for classification based on an ensemble of classification trees built by a doubly random process (Breiman, Machine Learning , 45: 5–32, 2001). These trees are then combined through a voting process that assigns the class with the most votes to be the individual's predicted class. Unlike the traditional regression models RF is a non-parametric procedure that makes no assumptions about the form of underlying relationships between the predictor variables and the target variable. RF provides a robust ranking of variable importance that can be used to weed out predictors unlikely to be associated with the outcome and is useful in areas of biology where hundreds to thousands of eligible predictors need to be examined. For example, Lunetta et al. ( BMC Genetics , 5:32, 2004) applied RF to identify a small set of relevant SNPs in a large-scale genome-wide association study and showed that as the number of interacting SNPs increases, the improvement in performance of RF relative to univariate Fisher exact test for screening also increases.We carried out a RF analysis on 2,107 patient-donor pairs by specifying 151 AAS position variables and 4 patient characteristic variables (age, disease, disease status, and patient-donor gender match) as predictors of D100S. Using a RF of 500 trees and Gini criterion for measuring variable importance the following 16 variables, listed in order of importance, were identified by RF to be predictive of D100S: age, disease stage, HLA-C 116, HLA-C 156, HLA-A 152, HLA-C 99, HLA-C 219, HLA-A 9, HLA-C 9, disease type, gender match, HLA-B 116, HLA-A 156, HLA-A 62, HLA-A 114, and HLA-C 97. This list confirms some of the AAS positions previously identified in the literature.In summary, RF is a useful screening tool that enables us to identify a small number of AAS position variables as important predictors of D100S. The positions and types of these AAS will be further investigated using more traditional multivariate regression techniques to elucidate the complex effect of specific HLA mismatches and their interactions.

Oral Second-Line Chemotherapy for Advanced Non–Small-Cell Lung Cancer: The Bottom Line

In this issue of the Journal of Clinical Oncology, Ramlau et al describe the results of a phase III trial comparing oral topotecan versus intravenous docetaxel in patients with previously treated advanced stage non–small-cell lung cancer (NSCLC). The study was large (more than 800 patients), employed a noninferiority design, and was performed by an experienced international group of lung cancer investigators. The authors report that oral topotecan is active in this clinical setting, and that the study met predefined criteria for noninferiority with regard to survival. What do these results mean for the practicing oncologist, and will they alter our second-line management of NSCLC patients? To put these data into perspective, we must first ask how this study stacks up against previously reported trials of second-line therapy. In the current study, for example, efficacy parameters of response rate and overall survival were not statistically different between docetaxel and topotecan (5% in each arm, and 31.7 v 27.9 weeks, respectively; P .057), whereas time to progression was superior in the docetaxel arm (13.1 v 11.3 weeks, respectively; P .02). Although both agents were reported to be relatively well tolerated, the hematologic toxicity profile favored docetaxel, as did the overall quality-of-life assessment (P .0001). In fact, despite a significant expansion of the therapeutic armamentarium, there appears to be no clear winner among the agents tested in randomized trials of second-line therapy, at least in terms of efficacy parameters (Table 1). This conclusion seems particularly well justified when one looks at the results from study to study with docetaxel at 75 mg/m, which served as a study arm in five of the seven trials listed. Most likely, variability in eligibility criteria and patient characteristics account for differences between studies. In addition to measures of efficacy and toxicity, docetaxel is reported to convey quality-of-life benefits in this clinical setting, and to be cost effective. So where do we go from here? With the exception of the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) erlotinib and gefitinib, for which patient characteristics such as sex (female), histology (adenocarcinoma or bronchioloalveolar carcinoma), smoking status (never-smoking), or tumor biomarkers (EGFR gene copy number or mutation status) portend a greater likelihood of benefit, there are no clear-cut clinical features, and as yet no generally accepted predictive biomarkers, to guide physicians in selecting from among the remaining available options for second-line therapy for the majority of patients with NSCLC. An obvious question is whether combinations of these second-line therapies are likely to be better than single agents in achieving the palliative goals of second-line therapy. Once again, there are no definitive results to suggest that combinations are superior, although many clinical trials are ongoing investigating the possibilities. Two potential considerations worthy of discussion are combinations of the chemotherapeutic agents listed above with EGFR TKIs or with antiangiogenic agents such as bevacizumab. With regard to the former, the possibility of antagonism between concurrently administered chemotherapy and EGFR TKIs has led to a series of studies evaluating the concept of pharmacodynamic separation, such as intermittent dosing of the EGFR TKI together with chemotherapy. At the same time, combinations of bevacizumab with chemotherapy, recently shown to improve survival in first-line therapy, are also of interest in secondline therapy, as exemplified by a joint North Central Cancer Treatment Group/Southwest Oncology Group trial investigating pemetrexed plus bevacizumab. Table 1. Results of Randomized Phase III Trials in Second-Line Treatment of NSCLC

Endovascular Recanalization Therapy in Acute Ischemic Stroke

To assess the outcome in acute ischemic stroke patients not eligible for systemic thrombolysis (outside the 3-hour time window, after surgery, or on anticoagulant) undergoing endovascular recanalization therapy (ERT) at the Columbia University Medical Center (CUMC) and to determine US nationwide usage and outcome of ERT in acute ischemic stroke. Patients treated at CUMC from 2001 to 2004 and the Nationwide Inpatient Sample (NIS) comprising 20% of all admissions in the United States from 1999 to 2002 were analyzed retrospectively. Thirty-one patients underwent ERT. Mean age was 68+/-14 years, 68% were female, and 45% nonwhite (occlusion sites: internal carotid artery 29%; middle cerebral artery 39%; posterior circulation 32%). Pharmacological or mechanical ERT was initiated beyond 3 hours after symptom onset (median time 4.4 hours) in 61%, 29% had surgery, and 39% were on anticoagulant medication. At discharge, 32% had modified Rankin Scale scores of 0 to 2 (52% discharged home or to rehabilitation facilities); overall mortality was 29%, of which 19% were fatal intracerebral hemorrhages. From the NIS cohort, 477 patients (0.17% of all strokes and 14% of all thrombolysis cases) underwent ERT. Fifteen percent died, and approximately 50% were discharged home or to rehabilitation facilities. Intracerebral hemorrhage occurred in 6%. Fewer good outcomes of the CUMC cohort may be explained by more unfavorable premorbid patient characteristics compared with the NIS cohort. Despite significant variability in patient characteristics and treatment methods among 2 sources of data analyzed, ERT in stroke patients not eligible for intravenous thrombolysis appears to be a relatively safe and effective treatment alternative that is being used increasingly nationwide.

Variability in clinical data is often more useful than the mean: illustration of concept and simple methods of assessment

Clinical investigators, although they are generally familiar with testing differences between averages, have difficulty testing differences between variabilities. To give examples of situations where variability is more relevant than averages and to describe simple methods for testing such data. Examples include: (1) testing drugs with small therapeutic indices, (2) testing variability in drug response, (3) assessing pill diameters or pill weights, (4) comparing patient groups for variability in patient characteristics, (5) assessing the variability in duration of clinical treatment, (6) finding the best method for patient assessment. Various fields of research, particularly in clinical pharmacology, make use of test procedures that implicitly, address the variability in the data. Tests specially designed for testing variability in data include the chi2-test for one sample, the F-test for 2 samples and Bartlett's or Levene's test for 3 or more samples. Additional methods include (1) the comparison of confidence intervals, and (2) testing confidence intervals against prior defined intervals of therapeutic tolerance or equivalence. Many of these tests are available in Excel and other statistical software programs and one such program is described. In the analysis of clinical data the variability in the data is often more important than averages. Eight simple methods for assessment variability are described to illustrate the value and importance of putting more emphasis on and this parameter.

Spinal cord injury without radiological abnormality in preschool-aged children: correlation of magnetic resonance imaging findings with neurological outcomes

Spinal cord injury without radiological abnormality (SCIWORA) was defined in the era when magnetic resonance (MR) images were not popularly used as diagnostic tools. Although it is generally accepted that MR imaging can effectively illustrate the level and severity of spinal cord injury in the acute phase of trauma, only a few reports of MR imaging studies of SCIWORA have been published. The authors retrospectively reviewed nine preschool-aged patients with SCIWORA to study the correlation between MR imaging findings and the outcomes of neurological deficits, with an elimination of the bias for age. Clinical manifestations, radiological images, surgical records, and MR imaging studies were reviewed. The pre- and postoperative neurological statuses of the patients were reappraised using American Spinal Injury Association scores and Nurick grades. Nonparametric tests were used to analyze the correlations among the variables of patient characteristics, MR imaging appearances of the injured spinal cord, and neurological outcome. Among the patients with SCIWORA younger than 8 years old, the different patterns of the injured spinal cords could be identified using MR imaging as transection, contusive hemorrhage, traumatic edema, and concussion. The MR imaging patterns of SCIWORA had significant prognostic correlations with the neurological outcomes of these patients; that is, a normal spinal cord appearance was prognostic of a complete recovery of neurological deficits, and intramedullary lesions correlated with permanent deficits with functional disability.

Surgical experience with symptomatic thoracic ossification of the ligamentum flavum

Symptomatic thoracic ossification of the ligamentum flavum (OLF) is rare, and its prognostic factors remain unclear. The authors retrospectively studied 24 patients with surgically treated thoracic OLF to delineate its prognostic factor. The clinical manifestations, radiological studies, surgical records, and pathological findings were reviewed. Preoperative and postoperative neurological data were reappraised using the American Spinal Injury Association and modified Japanese Orthopaedic Association (JOA) scoring systems. Spearman rank-correlation coefficients and nonparametric tests were used to analyze the correlations between the variables of patient characteristics, preoperative duration of symptoms, preoperative neurological status, associated spinal disorder(s) other than thoracic OLF, and the final functional outcome. Decompressive surgery is indicated in patients in whom symptomatic thoracic spinal cord compression is caused by intruding OLF. Magnetic resonance imaging can provide sufficient clues for the diagnosis of thoracic OLF. Higher preoperative modified JOA scores of 3 and 4 are positively correlated with better postoperatiVe functional recovery than lower scores. Surgery should be performed as soon as possible before independent ambulatory function is impaired.

Selecting representative case vignettes for clinical judgement studies: Examples from two heart failure studies

In the Clinical Judgement Analysis (CJA) tradition there are strong arguments in favour of using representative case vignettes. Due to methodological and practical constraints, however, it is often necessary to make compromises regarding representativity. In this article, we discuss our experiences in working with these problems in connection with two studies about general practitioners’ heart failure diagnoses. CJA is a method for investigating and describing decision-making in which both judges and judgement situations are taken into consideration. This means that when we want to study physicians’ diagnoses, both the participating physicians as well as the case vignettes should be sampled to be representative for the diagnostic situation. If representativity is interpreted in a strictly statistical sense, the case vignettes should reflect a well identified population of patients regarding values, distribution and intercorrelations of the relevant patient characteristics (variables). Creating a set of representative case vignettes meeting all theoretical requirements will often be difficult. Selecting a relevant population and relevant variables, deciding about the appropriate number of variables and case vignettes, and deciding whether authentic patients or constructed case vignettes should be used are some of the problems that must be dealt with.

A Comparison Between Audio Computer-Assisted Self-Interviews and Clinician Interviews for Obtaining the Sexual History

The objective of this study was to compare reporting between audio computer-assisted self-interview (ACASI) and clinician-administered sexual histories. The goal of this study was to explore the usefulness of ACASI in sexually transmitted disease (STD) clinics. The authors conducted a cross-sectional study of ACASI followed by a clinician history (CH) among 609 patients (52% male, 59% white) in an urban, public STD clinic. We assessed completeness of data, item prevalence, and report concordance for sexual history and patient characteristic variables classified as socially neutral (n=5), sensitive (n=11), or rewarded (n=4). Women more often reported by ACASI than during CH same-sex behavior (19.6% vs. 11.5%), oral sex (67.3% vs. 50.0%), transactional sex (20.7% vs. 9.8%), and amphetamine use (4.9% vs. 0.7%) but were less likely to report STD symptoms (55.4% vs. 63.7%; all McNemar chi-squared P values <0.003). Men's reporting was similar between interviews, except for ever having had sex with another man (36.9% ACASI vs. 28.7% CH, P <0.001). Reporting agreement as measured by kappas and intraclass correlation coefficients was only moderate for socially sensitive and rewarded variables but was substantial or almost perfect for socially neutral variables. ACASI data tended to be more complete. ACASI was acceptable to 89% of participants. ACASI sexual histories may help to identify persons at risk for STDs.

Geographic variability in patient characteristics, treatment and outcome in an international trial of magnesium in acute myocardial infarction

Background The interpretation of clinical trials and efforts directed at reducing the worldwide burden of coronary disease must take regional differences into account. This study examined the regional differences in baseline characteristics, treatment, and outcome in patients presenting with ST elevation myocardial infarction (STEMI) who were entered into the Magnesium in Coronaries (MAGIC) trial. Methods and results MAGIC randomized 6213 patients to standard care with either placebo infusion or infusion of intravenous magnesium sulphate. There was no difference in mortality between these groups. For this analysis, three geographic regions were identified (Region 1=United States and Canada; Region 2=Bulgaria, Georgia, and Russia; Region 3=Austria, Belgium, Chile, Hungary, Israel, the Netherlands, New Zealand, and Venezuela) and compared with respect to baseline characteristics, treatment, and 30-day mortality. Patients in Region 2 had the highest prevalence of adverse risk factors at entry, including history of prior myocardial infarction, heart failure, stroke, and hypertension; anterior location of index acute myocardial infarction; and presence of pulmonary congestion at presentation. Furthermore, Region 2 patients infrequently received reperfusion therapy compared with those in Region 1. Region 3 was intermediate in this regard. Mortality was highest in Region 2, least in Region 1, and intermediate in Region 3. Conclusion Geographic location, particularly, parts of Eastern Europe, is strongly and independently associated with mortality following STEMI. This geographic variation in mortality confirms prior reports, although adequate explanations continue to be elusive and are beyond the scope of this large simple trial. Future international trials must recognize this variation in design, analysis, and interpretation.

Outcome for cardiothoracic surgical patients requiring multidisciplinary intensive care

Background and objective: Patients who require multidisciplinary intensive care after cardiac surgery have a poor prognosis. The aim was to investigate factors in the mortality of this group of patients at 6 months. Methods: A retrospective analysis was made of the 6-month mortality rate in 301 adults who required admission to a multidisciplinary intensive care unit following cardiac surgery from 1991 to 1997. Mortality was correlated with clinical and patient characteristic variables. Results: The intensive care mortality rate was 34% and at 6 months after patients' discharge from intensive care it was 51%. There were positive correlations with death at 6 months for ventricular failure (odds ratio of death 3.4, P = 0.002), sepsis (odds ratio 3.0, P = 0.004) and age over 80 yr (odds ratio of death 9.2, P = 0.034). Patients who had undergone isolated coronary artery graft surgery (odds ratio of death 0.28, P = 0.036) or thoracic surgery (odds ratio of death 0.22, P = 0.042) had better 6-month outcomes. Patients with respiratory or renal failure in the absence of ventricular failure or sepsis had a 6-month mortality rate of 36%; but the lower mortality rate did not achieve statistical significance. Conclusions: The 6-month mortality rate of 51% in a group of patients requiring multidisciplinary intensive care after cardiac surgery is consistent with previous studies; mortality was particularly high in extreme old age and in patients referred with sepsis or ventricular failure. Those patients with uncomplicated respiratory or renal failure had a better outcome than the group as a whole.

Factors influencing risk-adjusted patient satisfaction after coronary artery bypass grafting

Factors influencing risk-adjusted patient satisfaction after coronary artery bypass grafting

Commentary: dose intensive chemotherapy in acute myeloid leukemia

Therapy for adults with acute myeloid leukemia (AML) generally includes cytarabine (Ara-C) and an anthracycline. Escalation of the Ara-C dose, either during the post-remission phase of therapy, or, during induction has improved survival for some patients with AML, those under age 60 and particularly those with favorable cytogenetic changes, t(8:21) and inv (16) [1,2]. An enhanced efficacy of higher doses of anthracyclines is less clearly established. In this issue, Thomas et al. report on a study evaluating the feasibility of using higher than standard doses of mitoxantrone in combination with Ara-C and etoposide in patients with relapsed or refractory AML [3]. Mitoxantrone, an anthracenedione, has demonstrated antileukemic activity similar to that of the anthracyclines when given in comparable myelosuppressive doses [4]. A dose of 12 mg/m daily for 3 days in combination with Ara-C (cumulative dose 700–1000 mg/m) has been considered the standard dose of mitoxantrone. The rationale for escalation of the dose of mitoxantrone has been documented both in vitro and in phase I clinical and pharmacokinetic trials. Studies in ovarian cancer and leukemic cells have demonstrated a steep dose response curve in clonogenic assays and an enhancement of apoptotic cell death has been observed in leukemic cells exposed to increasing concentrations of mitoxantrone [5–7]. A phase I study demonstrated that up to 80 mg/m could be given with Ara-C as induction therapy for adults with AML and that high concentrations of mitoxantrone were achievable in vivo, equivalent to levels shown to be highly cytotoxic in vitro [8]. In the study reported by Thomas et al., mitoxantrone at a dose of 36–60 mg/m was administered in combination with an intermediate dose of Ara-C( 500 mg/ m×6 doses) and etoposide 200 mg/m×3 doses as salvage therapy for patients with AML. Overall, this regimen was well tolerated with only one reported induction death in the 24 patients treated. Apart from severe myelosuppression, which was seen in all patients, mucositis and gastrointestinal toxicity was moderate and not dose limiting. Reversible hepatic dysfunction and cardiac toxicity manifested by a dimunition in left ventricular ejection fraction was reported as the dose limiting toxicity in patients receiving 60 mg/m of mitoxantrone. Although the earlier dose-escalation study with mitoxantrone in acute leukemia had established a maximally tolerated dose (MTD) at 80 mg/m in combination with intermediate dose Ara-C in earlier treated as well as untreated patients [8], variability in patient characteristics, i.e cumulative dose of anthracyclines received prior to treatment with the high-dose mitoxantrone-based regimen, may have accounted for the differences in MTD’s observed. Nevertheless, the Thomas study confirms the feasibility of delivering a higher than standard dose of mitoxantrone in patients with acute leukemia. This study also confirms the experience that intensive induction therapy is effective in AML. Although a small pilot study, the response rate of 67% in the salvage setting reported by Thomas et al. is impressive. Most of the efforts to intensify induction therapy in AML have focused on the escalation of the dose of Ara-C. This regimen differs in that it includes a relatively lower cumulative dose of Ara-C (3 gm/m) compared with other high-dose Ara-C-based regimens (24–36 gm/m), but instead delivers a higher than standard dose of mitoxantrone and includes a second topoisomerase II inhibitor, etoposide. The dose-dependant efficacy of Ara-C is well established, but what is E-mail address: ejf2001@mail.med.cornell.edu (E.J. Feldman).

Clinical management of acute pain

The clinical management of acute pain has been impeded by traditions and misconceptions which have resulted in suboptimal application to the patient of the currently available methods of pain control. The search for new drugs and exotic ways to deliver them has further obscured many of the basic principles which should guide management. Standard regimens fail because of the wide, unpredictable variability in pain intensity, patient characteristics, and pharmacological responses. Treatment needs to be individualized for each patient. Unrelieved acute pain produces psychological, physiological and socioeconomic consequences. Pre-emptive analgesia may damp down the development of both immediate and long-term pain following surgery and adequate psychological preparation can improve coping abilities. The delivery of opioid analgesics can be improved using patient controlled analgesia or spinal administration in some cases. Regional analgesia, often using simple techniques, can produce excellent pain relief. Overall management and staff education should be delegated to an acute pain service.

Adherence in a behavioral alcohol treatment program.

This report examines the correlates of early treatment termination by patients being treated for alcohol abuse or dependence. All of the study subjects were participants in a controlled experimental investigation of the differences in clinical outcome and treatment cost of extended inpatient and partial hospital treatment. A large number of clinical variables demonstrated no difference between groups, except for the greater likelihood of a DSM III Axis I diagnosis of alcohol abuse or dependence in the treatment completers. In contrast, three of four system variables differentiated completers from noncompleters. Patients treated by hospital-employed psychiatrists, in contrast to private psychiatrists, were more likely to complete the program; 4 sequential months in the middle phase of the study were associated with noncompletion of treatment; and patients who were detoxified on the preferentially designated unit were more likely to receive some specialized alcohol treatment. The authors interpret these data to indicate that treatment adherence is influenced by factors affecting the cohesiveness of the treatment delivery system. The failure of patient characteristic variables to predict treatment adherence may well be a result of their comparative insignificance in relation to system variables.