A matter of trust: patient barriers to primary medication adherence.

Primary medication adherence occurs when a patient properly fills the first prescription for a new medication. Primary adherence only occurs about three-quarters of the time for antihypertensive medications. We assessed patients' barriers to primary adherence and attributes of patient-provider discussions that might improve primary adherence for antihypertensives. In total, 26 patients with incomplete primary adherence for an antihypertensive, identified using their retail pharmacy claims, participated in four focus groups. Following a moderators' guide developed a priori, moderators led patients in a discussion of patients' attitudes and experiences with hypertension and receiving an antihypertensive medication, barriers to primary adherence, and their preferences for shared decision making and communication with providers. Three authors analysed and organized data into salient themes, including patients' anger about and suspicion of their hypertension diagnosis, the need for medication and providers' credibility. A trusting patient-provider relationship, shared decision-making support, full disclosure of side effects and cost sensitivity were attributes that might enhance primary adherence. Developing decision support interventions that strengthen the patient-provider relationship by enhancing provider credibility and patient trust prior to prescribing may provide more effective approaches for improving primary adherence.

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT): clinical center recruitment experience.

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) is a randomized clinical outcome trial of antihypertensive and lipid-lowering therapy in a diverse population (including substantial numbers of women and minorities) of 42,419 high-risk hypertensives aged > or = 55 years with a planned mean follow-up of 6 years. In this paper, we describe our experience in the identification, recruitment, and selection of clinical centers for this large simple trial capable of meeting the recruitment goals outlined for ALLHAT, and we highlight factors associated with clinical center performance. Over 135,000 recruitment brochures were mailed to physicians. Requests for information and application packets were received from 9351 (6.8%) interested investigators. A total of 1053 completed applications were received and 909 sites (86%) were eventually approved to join the trial. Of the approved sites, 278 either later declined participation or were never activated, and 8 were closed within a year for lack of enrollment. The final 623 randomizing centers exceeded the trial's recruitment goal to enroll at least 40,000 participants into the trial, although the recruitment period was extended 1.5 years longer than planned. Fewer than a quarter of the sites (22.6%) were recruited from academic medical centers or Department of Veterans Affairs Medical Centers. More than half of the sites (54.7%) were private solo or group practices, which contributed 53% of randomized participants. Community health centers comprised about 8% of the ALLHAT sites and 2.9% were part of health maintenance organizations. More than 22% of the principal investigators reported that they had no previous clinical research experience. In summary, ALLHAT was successful in recruiting a diverse group of clinical centers to achieve its patient recruitment goals.

Using the new cholesterol guidelines in everyday practice.

The third Adult Treatment Panel guidelines from the National Cholesterol Education Program, released in May 2001, depart from previous guidelines in several ways. As in previous guidelines, treatment and treatment goals are based not only on lipid levels but also on the patient's risk status. The method for calculating risk, however, has been refined considerably. Patients are classified in the highest-risk group if they have any of these disorders: known coronary artery disease, diabetes mellitus, peripheral vascular disease, abdominal aortic aneurysm, carotid artery disease, or a 10-year risk of a coronary event of more than 20% (as determined by use of a scoring method).

Screening for cardiovascular disease. Concepts, conflicts, and consensus.

CVD in the United States is prevalent, costly, and disabling. Wherever in the arterial tree atherosclerosis occurs, the process appears to begin in youth, to develop under the influence of the same risk factors, and to be amenable to the same interventions. The relationship between CVD and its associated risk factors is continuous, is graded, and extends below thresholds previously defined as normal. This observation, in turn, is based on an appreciation that in our society, the gap between normal and optimal can be considerable. CVD is a multifactorial process, often related to modifiable lifestyle choices; we focus on any single risk factor to the exclusion of others puts patients in danger. Because risk factors rarely occur in isolation, risk assessment must be as multifactorial as the underlying disease process. By understanding differences between risk factors in terms of the impact of their modification on the underlying disease, targeted interventions become possible that are tailored to the likelihood of an individual patient acquiring CVD. To change the overall prevalence of an epidemic disease such as CVD, however, such a high-risk approach must be applied in concert with a population strategy that seeks to effect smaller degrees of change in the large segment of society that may be at only moderate risk but--because of their great numbers--bears most of the morbidity and mortality of CVD. Finally, despite the remarkable progress that has been made in our understanding of the pathophysiology of CVD and the effectiveness of risk factor modification, significant gaps remain between knowledge and behavior. Fewer than 50% of diabetics are even aware that they have the disease. Only a third of those whose lipid levels qualify them for treatment receive intervention of any kind, including dietary advice. Only 27% of hypertensives have their blood pressure adequately controlled. The potential impact of more vigorous screening practices in the primary care setting on the health of individuals and communities cannot be overstated.

Physician noncompliance with the 1993 National Cholesterol Education Program (NCEP-ATPII) guidelines.

BACKGROUND: We sought to determine the frequency with which physicians follow National Cholesterol Education Program (NCEP-ATPII) guidelines in screening for cardiovascular risk factors and treating hyperlipidemia. METHODS AND RESULTS: We conducted a retrospective chart review on randomly sampled charts of 225 patients admitted to the coronary care unit between January and June 1996. The main outcome measures were rates of physician screening for coronary heart disease risk factors; rates of counseling for cigarette cessation, diet, and exercise; and extent of use of NCEP algorithms for obtaining LDL cholesterol values and treating hypercholesterolemia. Screening rates for interns (who performed best) were: cigarette use (89%), known coronary heart disease (74%), hypertension (68%), hyperlipidemia (59%), family history (56%), diabetes (37%), postmenopausal hormone therapy (11%), and premature menopause (1%). Four percent of smokers were counseled to quit, 14% of patients were referred to dietitians, and 1% were encouraged to exercise. A full lipid panel was obtained in 50% of patients in whom it was indicated on the basis of NCEP criteria. Patients were more likely to receive lipid-lowering treatment if NCEP criteria indicated that they should, but 36% of hospitalized patients and 46% of patients who should have been treated on discharge were not. CONCLUSIONS: Physicians are poorly compliant with NCEP guidelines for risk factor assessment and counseling, even in patients at high risk for coronary heart disease. Physicians follow NCEP-ATPII algorithms for obtaining an LDL value, a key step in evaluating the need for treatment, only 50% of the time. NCEP criteria seem to influence the decision to initiate lipid-lowering therapy, but significant numbers of eligible patients remain untreated.