Operational aspects of terminating the doxazosin arm of The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).

The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) is a randomized, practice-based trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI). The double-blind, active-controlled component of ALLHAT was designed to determine whether the rate of the primary outcome-a composite of fatal coronary heart disease and nonfatal myocardial infarction-differs between diuretic (chlorthalidone) treatment and each of three other classes of antihypertensive drugs: a calcium antagonist (amlodipine), an angiotensin-converting enzyme inhibitor (lisinopril), and an alpha-adrenergic blocker (doxazosin) in high-risk hypertensive persons ages 55 years and older. In addition, 10,377 ALLHAT participants with mild to moderate hypercholesterolemia were also enrolled in a randomized, open-label trial designed to determine whether lowering serum LDL cholesterol with an HMG CoA reductase inhibitor (pravastatin) will reduce all-cause mortality as compared to a control group receiving "usual care." In January 2000, an independent data review committee recommended discontinuing the doxazosin treatment arm. The NHLBI director promptly accepted the recommendation. This article discusses the steps involved in the orderly closeout of one arm of ALLHAT and the dissemination of trial results. These steps included provisional preparations; the actual decision process; establishing a timetable; forming a transition committee; preparing materials and instructions; informing 65 trial officers and coordinators, 628 active clinics and satellite locations, 313 institutional review boards, over 42,000 patients, and the general public; reporting detailed trial results; and monitoring the closeout process. Control Clin Trials 2001;22:29-41

Patients' explanatory models for heart failure and COPD exacerbations.

Although there is extensive information on the disease aspect of heart failure (HF) and chronic obstructive pulmonary disease (COPD), the illness aspect of these diseases has received limited attention. This limitation in our knowledge is of concern because these diseases are increasing in incidence and prevalence and contributing to the premature morbidity and mortality of thousands of persons. This naturalistic inquiry study was undertaken to describe the explanatory models (EMs) of persons hospitalized for HF (n = 30) or COPD (n = 30) exacerbations. In semistructured interviews, participants offered descriptions of the etiology, cause, and effects of their disease exacerbations and identified interventions that they believed would have helped prevent their hospitalizations or helped them to live better at home. The findings provide a basis for understanding the EMs of persons with HF or COPD as an initial step in making health care more relevant.

Hyperventilation and head injury: controversies and concerns.

The use of hyperventilation for the treatment of severe head injuries has been the standard of care for more than two decades in the prehospital, emergency department and critical care settings. Controversy has surrounded its use, even when advocates recommended use for all unconscious, head-injured patients. Autoregulation, cerebral acidosis control, reduction of elevated intracranial pressure and the "steal phenomenon" were thought to be beneficial effects of hyperventilation therapy. Current researchers and developments in technology, however, have provided controversial information which suggests that hyperventilation therapy can be harmful, warranting the need for careful monitoring and selective treatment. This information calls into question the use of unmonitored hyperventilation therapy in the prehospital and early hospital settings.

A look at recent hyperventilation studies: outcomes and recommendations for early use in the head-injured patient.

During the past decade, mounting controversy surrounding the use of hyperventilation for the treatment of head injury has raised concerns about its safety and therapeutic benefits. A recent investigation of the medical literature was conducted to determine if outcomes for the head-injured patient continued to support the use of indiscriminate, and often unmonitored, hyperventilation in the pre-hospital and early hospital phases of care, and to determine if current investigators are recommending the use of hyperventilation for the initial treatment of all unconscious head-injured patients. Findings suggest that head-injured patients in the pre-hospital and early phases of care are at increased risk for suffering hyperventilation-induced secondary brain injury. Current researchers are now recommending a highly monitored, cautions and selective approach to care; this approach calls our current practice into question.

An observational study of the emergency triage nursing role in a managed care facility.

Introduction A 72-hour observational pilot study was conducted at a large managed-care facility to determine what functions triage nurses fulfilled, how often they fulfilled these functions, and how much time was taken for these functions. Methods Patient arrival times, nursing activities, and patient dispositions were recorded. Activities were classified as either primary or nonprimary, according to defined triage purposes. Two alternating observers collected data continuously for 72 hours, during which they observed 13 triage nurses as they completed their regularly scheduled shifts. All nonprimary functions that occurred while the triage nurses fulfilled primary functions were classified as interruptions. All data were entered into computer software and whole minutes were used for calculating times. Results Nurses provided triage for 466 patients, and 655 telephone calls occurred. Twenty-nine physical triage activities and 26 telephone activities were observed. Telephone functions occupied about 22% of the time. Nonprimary telephone or triage functions interrupted 251 (54%) of all patients who were seen for triage. These interruptions notably increased pretriage waiting times for all patients who were interrupted but were most significant for patients with acuity levels 2 (p < 0.05) and 3 (p < 0.05). Number of interruptions and length of time spent waiting to see the triage nurses were significantly correlated (r = 0.69). Discussion Our study describes a method of evaluating triage nursing activities and suggests that some functions may contribute to delays in physician and nurse access.

Events in the cardiac arrhythmia suppression trial: baseline predictors of mortality in placebo-treated patients.

Patients randomized to placebo in the encainide and flecainide arms of the Cardiac Arrhythmia Suppression Trial (CAST) have been found to have a relatively low 1-year mortality rate of 3.9% in comparison with previous studies of patients in the postmyocardial infarction period. To determine the comparability of CAST with previous studies, baseline variables were examined in the 743 patients randomized to placebo in the flecainide and encainide arms of CAST. Twenty-three baseline characteristics were correlated with major outcome events: arrhythmic death (16 events), total mortality (26 events) and congestive heart failure (51 events). On multivariate analysis the risk of new or worsening congestive heart failure was significantly associated with diuretic use, diabetes, high New York Heart Association functional class, age, prolonged QRS duration and low ejection fraction. The risk of arrhythmic death or resuscitated cardiac arrest was significantly associated with an index Q wave myocardial infarction, history of heart failure, use of digitalis, diabetes and prolonged QRS duration. Total mortality or resuscitated cardiac arrest was significantly associated with an index Q wave myocardial infarction, diabetes, ST segment depression, high functional class, prolonged QRS duration and low ejection fraction. The variables at baseline associated with mortality from all causes or arrhythmic death or resuscitated cardiac arrest and heart failure in the CAST placebo-treated patients are similar to those identified in previous postmyocardial infarction studies. Thus, the observation of increased mortality in CAST associated with the administration of encainide and flecainide for suppression of ventricular premature depolarizations is probably applicable to any comparably defined group of patients in the postmyocardial infarction period.

Mucinous (adenocystic) sweat gland carcinoma of the great toe.

The authors describe a rare case of mucinous (adenocystic) eccrine carcinoma isolated in the hallux and present a review of the literature. The potential for metastases involving this skin tumor is low with local excision and 1-year follow-up the treatment of choice.