Selection of clinical, patient-reported, and economic end points in acute exacerbation of chronic bronchitis.

BACKGROUND: Acute exacerbation of chronic bronchitis (AECB) places tremendous burden on patients, providers, employers, and health care systems. OBJECTIVE: The purpose of this paper is to (1) review the clinical, patient-reported, and economic measures used to evaluate disease burden and treatment effectiveness in AECB in clinical trials and (2) propose a guide for selecting study end points in AECB that will help capture all the relevant disease outcomes. METHODS: Two literature searches of the PubMed database were conducted to identify studies of clinical trials in bronchitis and evaluate the clinical, patient-reported, and economic end points used in these studies. RESULTS: Previous studies have focused primarily on clinician-assessed outcomes, which do not capture the full impact of AECB on patients' lives. Reporting mechanisms for most end points have been inconsistent, limiting the ability to compare information or interpret differences. Previous studies have given limited attention to patient-reported outcomes and the economic implications of AECB. Patient-reported outcomes such as speed of symptom relief and work productivity are important parameters for assessing treatment effectiveness and provide practical information for treatment evaluation. CONCLUSIONS: Additional research is needed to develop, examine, and validate patient-reported outcomes and the indirect costs of AECB. Measuring the relevant clinical, economic, and patient-reported outcomes in AECB patients using standardized methods may lead to a clearer understanding of the disease burden and the role, effectiveness, and cost-effectiveness of antibiotic treatment.

Workplace costs associated with acute exacerbation of chronic bronchitis: a comparison of moxifloxacin and levofloxacin.

Past research on acute exacerbation of chronic bronchitis (AECB) has not quantified related work loss. This exploratory study used data from a comparative trial of moxifloxacin versus levofloxacin to examine and compare workplace-related indirect costs. Both groups reported considerable absenteeism and lowered work productivity. However, patients taking moxifloxacin reported significantly higher work productivity than those taking levofloxacin (70% vs. 50%; P = .03). This translated into substantial indirect cost savings with moxifloxacin of $726/patient/year. Antibiotic choice in AECB can affect worker productivity and workplace-related indirect costs. Both insurers and employers should consider workplace-related indirect costs in addition to direct medical expenses when making formulary selections.

Agency for Health Care Policy and Research clinical practice guidelines.

OBJECTIVE: To review and summarize past activities of guidelines development at the Agency for Health Care Policy and Research (AHCPR) to enhance understanding of its new role and facilitate the development of new guidelines. DATA SYNTHESIS: The current Congressional climate and past criticisms of the guidelines development process have caused the AHCPR to reevaluate the way it produces guidelines. This assessment has resulted in the AHCPR restructuring its role to serve now as a science partner with private and public organizations. CONCLUSIONS: The development and role of evidence-based clinical practice guidelines are discussed, and the new roles of the AHCPR are described.

What are outcomes?

Understanding the important aspects of measuring outcomes will prepare pharmacists for changes in the marketplace and help them to assess the results of studies that will appear in subsequent issues of the Journal of the American Pharmaceutical Association and the research journals of other health services professions. In any evaluation of quality, all three quality measures (structure, process, and outcomes) must be considered. No one measure, in isolation, can describe the quality of care provided. Thus, the best patient care will come from health care practitioners who document structure, process, and outcomes and who evaluate these measures to provide appropriate care. The pharmacist cannot dispense prescriptions or provide pharmaceutical care without a pharmacy, drug inventory, or patient profiles, all of which are important structural inputs. The pharmacist takes a medication history, monitors the drug regimen, and counsels the patient on the appropriate way to use the treatment, all vital process activities. The objective of these inputs and actions is to improve the health status of the patient. Outcomes, therefore, are the intended endpoints of care, and occasional unintended effects (e.g., adverse drug reactions) as well. The future of pharmacy rests on demonstrating the positive effect of pharmaceutical care on patient outcomes. Pharmacists have always been part of the system of checks and balances in health care delivery. As the provision of health services changes, opportunities to assess the process and structure of care and to document patient outcomes will increase. Pharmacists are well positioned to intervene in patient care, but if they do not demonstrate the value of pharmacy services, they will face competition from alternative providers. Some have even suggested less expensive alternatives to having pharmacists dispense medications. Pharmacists must establish that their role goes beyond dispensing to include cognitive services such as compliance programs, screening services, glucose monitoring, and disease management programs. Pharmacists must document their role and its effects on patient outcomes.

Pharmacoepidemiology of bleeding events after use of r-alteplase or streptokinase in acute myocardial infarction.

OBJECTIVE: To determine in nonresearch, general medical practice conditions the comparative incidence and types of bleeding complications after the use of streptokinase (SK) and r-alteplase (recombinant tissue plasminogen activator, rt-PA) to treat acute myocardial infarction (AMI). DESIGN: Retrospective medical record review of concurrently treated patients (96-hour observation posttreatment) in 32 participating hospitals in the US. MAIN OUTCOME MEASURES: The medical record description of all bleeding events regarding the body site affected, changes in hemoglobin concentrations, blood products administered, and clinical outcome (permanent sequelae or death). Bleeding severity was determined by defined criteria. CONTROL DATA: Comorbidity and concomitant medications (e.g., aspirin, heparin, warfarin) likely to predispose or contribute to bleeding events were analyzed. DATA ANALYSIS: Logistic regression analysis. RESULTS: Data from 419 patients who received rt-PA and 207 who received SK were evaluated. In the 96-hour period after initiation of thrombolytic therapy, 30.5 and 31.9 percent of rt-PA and SK patients, respectively, experienced one or more bleeding events (crude risk ratio [CRR] = 1.04; 95 percent confidence interval [CI] 0.91-1.14; p = 0.73). In the first 24-hour period, 21.5 percent of rt-PA and 15.9 percent of SK patients experienced bleeding events (CRR = 0.74; 95 percent CI 0.42-1.15; p = 0.08). The leading types of bleeding and percents of all patients affected were: perivascular access site (18.4 percent), gastrointestinal (6.4 percent), skin/soft tissue/muscle (5.0 percent), urinary (3.4 percent), pulmonary (2.2 percent), systemic (1.9 percent), and oral (1.4 percent). Intracranial bleeding occurred in 4 rt-PA and 2 SK patients; 4 of these patients died. Events deemed clinically significant occurred in 15 rt-PA and 9 SK patients (3.8 percent of all patients). Ten patients likely died from these events, 6 within the first 24 hours. Three rt-PA patients and 1 who received SK (0.6 percent) died of cerebrovascular events within the first 24 hours. After controlling for demographic factors and therapeutic variables, using logistic regression analyses, no thrombolytic-related differences were found in the incidence or severity of bleeding following use of the two thrombolytics. CONCLUSIONS: These clinical data do not support a theoretical advantage of rt-PA to cause less bleeding propensity than SK.