Developing improved observational methods for evaluating therapeutic effectiveness

Article Abstract:

The effectiveness of a specific treatment is often assessed by observational surveys of patients who undergo treatments that are not chosen using experimental principles. Therefore, the results of these surveys may be biased. One experimental principle is randomization, a method in which attempts are made to ensure that all subjects are as similar as possible and that subjects are randomly assigned to experimental groups. Randomization prevents unintentional selection bias in the study. Design principles and patient selection approaches were incorporated into observational study designs, and the effectiveness of these designs was assessed. The specific study concerned the use of beta-blocking agents in treating acute heart attack. Three approaches to selecting subjects were compared. In the first approach, the selection of subjects was restricted, based on criteria of the randomized clinical trial, and was referred to as the restricted cohort. In the second approach, patient selection was not restricted and was referred to as the expanded cohort. The third approach was the 'gold standard', or ideal randomized clinical trial, exemplified by the Beta Blocker Heart Attack Trial (BHAT). The results, which concerned variation in death rates due to different treatments, were similar for the restricted cohort and BHAT study. However, the study with the expanded cohort produced results that were very different from those of the BHAT study. Patient selection and eligibility criteria play important roles in confirming the validity of results. The improvements in the selection of patients may enhance the quality of observational study designs and help to more accurately assess the effectiveness of various treatments that cannot be tested in randomized clinical trials. (Consumer Summary produced by Reliance Medical Information, Inc.)

Standards, Methods, Evaluation, Therapeutics, Experimental design, Research design, Scientific surveys

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Patient acceptance of influenza vaccination

Article Abstract:

This study, carried out in the Primary Care Center of Yale-New Haven Hospital, addressed the problem of the low rate of vaccination against influenza among patients attending this university hospital-based clinic. Information concerning vaccination was given to all health care providers. Patients seen in the clinic were told of the vaccine and their responses were recorded. Those who refused vaccination were identified and matched to patients who accepted vaccination; the matched patients were interviewed by telephone to determine their reasons for accepting or refusing. Vaccination was indicated for 624 patients, half of whom had undergone vaccination previously. Four hundred sixty-six patients were actually vaccinated, for a 75 percent vaccination rate. Seven factors were found to be significant in the 158 cases where vaccination was not performed. These factors were: patient belief that the vaccine would not prevent the flu; never having received pneumococcal vaccine (against pneumonia) or influenza vaccine; having felt sick after previous influenza vaccinations; having had fewer than five clinic visits during the previous year; or having commercial health insurance. Patients who accepted the vaccination did so most often to prevent illness (62 percent) or because their health care provider had recommended it (40 percent). Patients' demographic characteristics and their medical diagnoses were not associated with acceptance of vaccination. These results indicate that many patients who initially refuse influenza vaccination could be convinced to accept it by their health care provider. (Consumer Summary produced by Reliance Medical Information, Inc.)

Management, Physician and patient, Physician-patient relations, Demographic aspects, Surveys, Influenza vaccines, Patient compliance, Influenza

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Does prophylaxis prevent postdental infective endocarditis? a controlled evaluation of protective efficacy

Article Abstract:

The American Heart Association recommends that antibiotics be administered to patients with specific heart lesions or abnormalities during dental procedures to prevent endocarditis, or inflammation of the heart lining, due to bacterial infection, despite the lack of evidence showing the value of prophylactic or preventive antibiotic therapy. The effectiveness of antibiotic prophylaxis, during dental procedures, to reduce the risk of infective endocarditis was evaluated in 32 patients with high risk heart lesions, including diseases of the mitral valve, aorta, and congenital or birth-related heart defects. The use of antibiotic prophylaxis was verified by interviews with patients and information from dentists, and defined as antibiotics taken before and after the dental procedure. Antibiotic prophylaxis was used in only one of eight patients who developed endocarditis within 12 weeks of a dental procedure as compared with 15 of 24 patients who did not develop endocarditis. These results indicated a 91 percent protective efficacy of antibiotic prophylaxis. Antibiotics may be useful in preventing endocarditis in patients with high risk heart disease, who are undergoing a dental procedure. (Consumer Summary produced by Reliance Medical Information, Inc.)

Health aspects, Case studies, Infection, Antibiotics, Endocarditis, Bacterial, Bacterial endocarditis, Dental prophylaxis

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