Medicolegal Issues

In the Literature


Performance Measures and Outcomes for Heart Patients

Fonarow GC, Abraham WT, Albert NM, et al. Association between performance measures and clinical outcomes for patients hospitalized with heart failure. JAMA. 2007 Jan 3;297(1):61-70

As our population ages, more emphasis will be placed on issues surrounding efficient and evidence-based care. Heart failure, which accounted for 3.6 million hospitalizations in 2003 and has an overall prevalence of 5 million, will be at the forefront of public policy. As pay for performance (P4P) and standards of care become increasingly prevalent, the medical community will need to scrutinize the standards by which we are measured.

The American College of Cardiology and the American Heart Association (ACC/AHA) developed guidelines for the treatment and care of patients with heart failure. These measures include heart failure discharge instructions, evaluation of left ventricle (LV) function, angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor antagonist (ARB) for LV dysfunction, adult smoking cessation counseling, and anticoagulation at discharge for patients with atrial fibrillation. Adherence to these performance measures should be based on evidence.

The authors’ goal was to determine the validity of these guidelines. The Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF) registry allowed for the documentation and follow-up of patients adhering to the heart failure guidelines as set forth by the ACC/AHA. The study assessed the relationship between these guidelines and clinical outcomes, including 60- to 90-day mortality and a composite end point of mortality or rehospitalization.

In this study the OPTIMIZE-HF registry was used as the source of prospective data collection. Ten percent of eligible patients were randomly selected from the registry between March 2003 and December 2004 from 91 hospitals. Eligibility for the OPTIMIZE-HF registry included patients 18 and older admitted for worsening heart failure or significant heart failure during their hospital stay. The performance measure of discharge instruction, smoking cessation, and anticoagulation were measured for all eligible patients. Patients with an ejection fraction of 40% or less, or moderate to severe systolic function, were included for the ACE inhibitor/ARB performance measure. One measure not included was treatment with beta-blockers at discharge. The authors included beta-blockers at discharge with metrics similar to those described for ACE/ARB criteria.

The conformity rates and process-outcome links were then determined for the performance measures and beta-blocker treatment as it related to 60- to 90-day mortality/rehospitalization.

The study focused on a random follow-up cohort of 5,791 patients from 91 hospitals. This was similar to the OPTIMIZE-HF cohort of 48,612 patients in 259 hospitals. Demographically, the average cohort’s age was 72, 51% male and 78% white, with 42% of patients diagnosed with ischemic heart disease and 43% with diabetes mellitus. These results were similar to the demographics of the overall OPTIMIZE-HF registry.

Of the eligible patients in the follow-up cohort, 66% (4,010) received complete discharge instructions. Eighty-nine percent of eligible patients (4,664) had their left ventricular function evaluated. For those patients with documented left ventricular systolic dysfunction (2,181), 83% were given an ACE inhibitor or ARB at discharge. Patients who had a diagnosis of atrial fibrillation were discharged with anticoagulation at a rate of 53%, and 72% of patients were counseled on smoking cessation. As compared with ACE inhibitors/ARB, similar results (84%) were seen for beta-blockers at discharge.

Only two of the five ACC/AHA performance measures were predictive of decreasing morbidity and mortality/rehospitalization in unadjusted analysis: patients discharged on ACE inhibitors/ARBs (odds ratio, 0.51; 95% CI 0.34–0.78; P- .002) and smoking cessation counseling. Beta-blockers, not a formal part of the ACC/AHA guidelines, were also a predictor of lower risk of both mortality and rehospitalization (odds ratio, 0.73; 95% CI, 0.55-0.96; P-0.02)

The OPTIMIZE-HF cohort analysis allowed for an opportunity to determine the degree of conformity for the ACC/AHA performance measures. The ACE inhibitors or ARB use at discharge was shown in the OPTIMIZE-HF cohort to have a relative reduction in one-year post discharge mortality by 17% (risk reduction, 0.83; 95% CI, 0.79-0.88) and a trend to lower 60- to 90-days post-discharge mortality and rehospitalization. Although smoking cessation had an early positive correlation, outcomes did not reach statistical significance. The measure of discharge instruction in the current study did not show a benefit on early mortality/rehospitalization in 60- to 90-days post discharge. It is unclear from this study if discharge instructions given to patients were either rushed or discussed in a comprehensive manner. This factor will need clarification and further research.

The measures of discharge instructions, smoking cessation, LV assessment, and anticoagulation for atrial fibrillation have not been examined as effective performance measures prior to this study. These measures were unable to show an independent decrease in 60- to 90-day mortality and rehospitalization.

Patients discharged with beta-blockers showed an association between lower mortality and rehospitalization. This association was found to be stronger than any of the formal ACC/AHA current performance measures.

The ACC/AHA guidelines are becoming standards of care for reporting to agencies such as Centers for Medicare and Medicaid Services or other P4P programs. To allow for improvement of quality, JCAHO and ACC/AHA designed the above criteria to act as a guide for the post discharge care of coronary heart failure patients. Because these criteria are the measures by which hospitals need to report, it will be necessary for data to show validity and a link between the clinical performance measures and improved outcomes.

Of the five measures stated, only ACE inhibitors/ARB at discharge was associated with a decrease in mortality/rehospitalization. Beta-blockers, currently not a performance measure, also showed this trend. Increased scrutiny needs to be part of the criteria for which hospitals and practitioners are being held accountable, and further research validating their effectiveness is warranted.

Risk Indexes for COPD

Niewoehner DE, Lockhnygina Y, Rice K, et al. Risk indexes for exacerbations and hospitalizations due to COPD. Chest. 2007 Jan;131(1):20-28.

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality in the U.S. and continues to increase its numbers annually.

The cornerstone of COPD diagnosis and key predictor of prognosis is a low level of lung function. Another important predictor of morbidity, mortality, and progression of disease is COPD exacerbations.

Unfortunately, the definition of an exacerbation is varied, ranging from an increase in symptoms to COPD-related hospitalizations and death.1 Therefore, prevention of COPD exacerbations is an important management goal. This study focuses on setting a risk model as a clinical management tool, similar to what exists for cardiovascular events or community acquired pneumonia. No previous study has attempted to identify risk factors for exacerbations using prospective data collection and a clearly stated definition of exacerbation.

The study was a parallel-group, randomized, double-blind, placebo-controlled trial in patients with moderate to severe COPD conducted at 26 Veterans Affairs medical centers in the United States. Subjects were 40 or older, with a cigarette smoking history of 10 packs a year or more, a clinical diagnosis of COPD, and a forced expiratory volume [FEV] of 60% or less predicted and 70% or less of the forced vital capacity [FVC].1 Patients were allocated to receive one capsule of tiotropium (18 mg) or placebo for six months.

Of the 1,829 patients selected, 914 were assigned to the tiotropium arm. Patients kept a daily diary, and the investigators collected data by monthly telephone interviews and by site visits at three and six months with spirometry evaluation. They evaluated the association between baseline characteristics, concomitant medications and the study drug and the time to first COPD exacerbation and the time to first hospitalization due to exacerbation. The authors defined an exacerbation as a complex of respiratory symptoms of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic corticosteroids and/or hospital admission.

The investigators found that a statistically significant greater risk for both COPD exacerbations and hospitalizations is associated with being of older age, being a noncurrent smoker, having poorer lung function, using home oxygen, visiting the clinic or emergency department more often, either scheduled or unscheduled, being hospitalized for COPD in the prior year, using either antibiotics or systemic steroids for COPD more often in the prior year, and using short-acting beta agonist, inhaled or oral corticosteroid at a baseline rate.

On the other hand, a statistically significant greater risk of only COPD exacerbation was seen in white patients, with presence of productive cough, longer duration of COPD, use of long-acting beta agonist or theophylline at baseline, and presence of any gastrointestinal or hepatobiliary disease. Lower body-mass index and the presence of cardiovascular comorbidity were associated with statistically significant greater risk for only hospitalization due to COPD.

The investigators also confirmed the previous suggestion that chronic cough is an independent predictor of exacerbation. Interestingly, they found that any cardiovascular comorbidity is a strong and independent predictor of hospitalizations due to COPD. It is unclear if cardiovascular disease truly predisposes subjects to COPD hospitalizations or merely represents a misdiagnosis because both diseases have similar symptoms.

Current smokers were identified as having lower risk of exacerbation and hospitalization, probably due to the “healthy smoker” theory—that deteriorating lung function causes the patient to quit smoking.

This study is the first to gather information about predictors of COPD exacerbations in a prospective fashion using a clear definition of exacerbation. The authors developed a model to assess the risk of COPD exacerbations and hospitalizations due to exacerbations in patients with moderate to severe COPD. Moreover, this model can easily be applied to individual patients and reproduced with simple spirometry and a series of questions.

Though this trial had a reasonable level of statistical significance, it is important to mention that the trial was conducted within a single health system (Veterans Affairs medical centers), there were few women in the study, and the eligibility criteria were very specific.


  1. Mannino DM, Watt G, Hole D, et al. The natural history of chronic obstructive pulmonary disease. Eur Respir J. 2006 Mar;27(3):627-643.

Glucose Management in Hospitalized Patients

Leahy JL. Insulin Management of diabetic patients on general medical and surgical floors. Endocr Pract. Jul/Aug 2006;12(Suppl3):86-89.

Although the rationale behind the science for tight control of blood sugar in subsets of hospitalized patient populations is without debate when it comes to the majority of general ward patients, the management of hyperglycemia becomes more of an art. Increasingly we recognize the effect of the relationship between improving glucose management and improving clinical outcomes.

Guidelines for inpatient targeted blood glucose levels exist, but hospitals are moving toward a more individualized approach to subcutaneous insulin protocols for their patients, thus moving beyond the passive sliding scale era.

Institution of an insulin protocol at one such hospital, the University of Vermont, highlights such an approach. The ongoing internal nonrandomized study exemplifies a two-tiered approach initially aimed at expanding the house physician comfort zone to change the culture of hyperglycemic management beyond simply avoiding hypoglycemia to one of an active and—per our current standards—aggressive individualized insulin protocol.

It seems the author envisions a gradual process allowing initial flexibility within the protocol, increasing the intensity of dosing as comfort zones expand. Throughout the process, the principles of determining a patient’s weight-based daily insulin needs are maintained, taking into consideration factors like comorbidities, severity of illness, amount of oral intake, steroid usage, and age. Then, the insulin regimen is physiologically (basal/bolus, basal, continuous) administered according to the route (i.e., total parenteral nutrition) and timing of their nutritional intake.

Adjustments being made to insulin regimens are based on fasting, pre-meal and bedtime glucose as well as the novel approach of bolus insulin after meals with short-acting insulin (i.e., lispro).

Unfortunately although the protocol does perhaps yield itself to being looked at more stringently—in terms of cost effectiveness, improved length of hospital stay, and improved clinical outcomes—the outcome studied here was primarily one of hospitalwide education in advancing the understanding and culture of aggressive individualized insulin protocols. These can often be even more statistically difficult to quantify. As self-reported, improve­­ments were made.

One of the most important aspects of this paper is that it draws attention to the paucity of evidence for improved clinical and monetary outcomes supporting the aggressive hospital management of hyperglycemia in the non-acutely ill patient. Often, the guiding principle is to avoid hypoglycemia. Detailing the specific protocols of one such approach serves as an example for the motivated reader.

Early Switch from IV to Oral Antibiotic in Severe CAP

Oosterheert JJ, Bonten JM, Schneider MME, et al. Effectiveness of early switch from intravenous to oral antibiotics in severe community acquired pneumonia; multicentre randomised trial. BMJ. 2006 Dec 9; 333:1193.

Community acquired pneumonia (CAP) is a common and potentially fatal infection with high healthcare costs. When patients are first admitted to hospitals, antibiotics are usually given intravenously to provide optimal concentrations in the tissues.

The duration of intravenous treatment is an important determinant of length of hospital stay (LOS). The concept of early transition from intravenous to oral antibiotic in the treatment of CAP has been evaluated before, but only in mild to moderately severe disease—and rarely in randomized trials.

This multicenter random controlled trial from five teaching hospitals and two medical centers in the Netherlands enrolled 302 patients in non-intensive care units with severe CAP. The primary outcome was clinical cure and secondary outcome was LOS. The inclusion criteria were adults 18 or older with severe CAP; mean pneumonia severity index of IV-V, new progressive infiltrate on chest X-ray, plus at least two other criteria (cough, sputum production, rectal temperature >38o C or <36.1o C, auscultative findings consistent with pneumonia, leukocytes >109 WBC/L or >15% bands, positive cultures of blob or pleural fluids, CRP three times greater times upper limit of normal).

Exclusion criteria included the need for mechanical ventilation, cystic fibrosis, a history of colonization with gram-negative bacteria due to structural damage to the respiratory tract, malfunction of the digestive tract, life expectancy of less than one month because of underlying disease, infections other than pneumonia that needed antibiotic treatment, and severe immunosuppression (neutropenia [<0.5 109 neutrophils/liter] or a CD4 count< 200/mm3).

Treatment failure was defined as death, still in hospital at day 28 of the study, or clinical deterioration (increase in temperature after initial improvement or the need for mechanical ventilation, switch back to intravenous antibiotics, or readmission for pulmonary reinfection after discharge).

Clinical cure was defined as discharged in good health without signs and symptoms of pneumonia and no treatment failure during follow-up.

The control group comprised 150 subjects who were to receive a standard course of seven days’ intravenous treatment. Meanwhile, 152 subjects were randomized to the early switch group. Baseline characteristics were similar in both groups. More than 80% of patients were in pneumonia severity class IV or V. Most patients received empirical monotherapy with amoxicillin or amoxicillin plus clavulanic acid (n=174; 58%) or a cephalosporin (n=59; 20%), which is in line with Dutch prescribing policies.

The most frequently identified microorganism was S pneumoniae (n=76; 25%). Atypical pathogens were detected in 33 patients (11%). Before day three, 37 patients (12%) were excluded from analysis, leaving 132 patients for analysis in the intervention group and 133 in the control group.

Reasons for exclusion included when the initial diagnosis of CAP was replaced by another diagnosis (n=9), consent was withdrawn (n=11), the protocol was violated (n=4), the patient was admitted to an intensive-care unit for mechanical ventilation (n=6), and the patient died (n=7). After three days of intravenous treatment, 108 of 132 patients (81%) in the intervention group were switched to oral treatment, of whom 102 (94%) received amoxicillin plus clavulanic acid (500+125 mg every eight hours).

In the control group, five patients did not receive intravenous antibiotics for all seven days because of phlebitis associated with intravenous treatment; none of them needed treatment for line-related sepsis. Overall duration of antibiotic treatment was 10.1 days in the intervention group and 9.3 days in the control group (mean difference 0.8 days, 95% confidence interval -0.6 to 2.0).

The duration of intravenous treatment was significantly shorter in the intervention group (mean 3.6 [SD 1.5] versus 7.0 [2.0] days, mean difference 3.4, 2.8 to 3.9). Average time to meet the discharge criteria was 5.2 (2.9) days in the intervention group and 5.7 (3.1) days in the control group (0.5 days -0.3 to 1.2) Total length of hospital stay was 9.6 (5.0) and 11.5 (4.9) days for patients in the intervention group and control group (1.9 days 0.6 to 3.2).

The authors’ findings provide strong evidence that early transition from intravenous to oral antibiotic is also viable in patients with highly graded Pneumonia Severity Index (PSI) CAP, not only in mild to moderately severe disease. This leads to reduced LOS, cost, and possibly reduced risk of line infections and increased patient satisfaction for early discharge.

Note: This study was done with patients suffering straightforward, uncomplicated CAP. The investigators’ findings cannot be applied to patients with other comorbidities like diabetes, COPD, heart failure, or sickle cell, which might require more days on intravenous antibiotic. One might also wonder what impact would have been seen had 37 patients not dropped off, and if another class of oral antibiotic such as quinolones had been used.

Last, the study sample showed S pneumoniae identified in 25% of cases and atypical pathogens to be 11%. What then are the majority of pathogens identified 64% of the time? This would have been another key factor that might have had a great effect on the result.

Although a larger sampling and further risk stratification (to include patients with other comorbidities) are needed, this study makes a valid point for early transition to oral antibiotics in highly graded, uncomplicated CAP. TH

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