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.
Perfetto
E M
EM
Healthcentric Associates, Stevensville, Maryland, USA.
Mullins
C D
CD
Subedi
P
P
Li-McLeod
J
J
D000208:Acute Disease; D000900:Anti-Bacterial Agents / Q000191:economics* / Q000627:therapeutic use; D029481:Bronchitis, Chronic / Q000175:diagnosis / Q000188:drug therapy / Q000191:economics*; D002986:Clinical Trials as Topic; D016206:Databases, Bibliographic; D023381:Endpoint Determination / Q000379:methods*; D006801:Humans; D018803:Models, Economic; D017063:Outcome Assessment, Health Care
D000900:Anti-Bacterial Agents