RESUMEN

The Recruitment and Enrollment Assessment in Clinical Trials (REACT) was a National Heart, Lung, and Blood Institute (NHLBI)-sponsored substudy to the Cardiac Arrhythmia Suppression Trial (CAST). Two-hundred-sixty (260) patients who enrolled in CAST and 140 partially or fully eligible patients who did not enroll were compared across several parameters, including demographic variables, disease severity, psychosocial functioning, health beliefs, recruitment experience, and understanding of informed consent procedures used in CAST. Significant predictors of enrollment included several demographic variables (e.g., being male, not having medical insurance), episodes of ventricular tachycardia, and health beliefs (e.g., extra beats are harmful, a higher degree of general health concern). Enrollment was higher for those who read and understood the informed consent and those who were initially recruited after hospital discharge, particularly nondepressed patients. In the multivariate model, the key variables that emerged were the patient's reading of the informed consent form and the patient's lack of medical insurance. These results suggest that (1) the clinical trial staff's interaction with the patient and the time when recruitment is initiated contribute significantly to the decision to enroll; and (2) it may be a greater challenge to motivate patients to enroll in future clinical trials if health care reform improves access to medical insurance coverage. Some of the significant variables are modifiable, suggesting interventions that may increase enrollment rates in future trials.

Asunto(s)

RESUMEN

BACKGROUND: Critically ill patients have received little attention in the caring literature and yet are a population for whom caring behaviors are particularly important. OBJECTIVES: To describe patients' perceptions of caring exhibited by professional nurses in a critical care unit and to describe the meaning to the patients of these demonstrations of caring. METHODS: We used a phenomenologic approach for this descriptive study, which was conducted on 13 patients hospitalized in a critical care unit for at least 48 hours within 48 hours of their transfer from the unit. We asked them to respond to two open-ended questions and recorded all interviews on audio tapes that were transcribed verbatim. RESULTS: Caring in a critical care unit is attentive, vigilant behavior on the part of the nurse. This vigilance embodies nurturance and incorporates highly skilled, technical practices, as well as basic nursing care and beyond. Caring is a healing process of which lifesaving actions by the nurse are a part. Identifying the characteristics of the individuals involved in this healing process was one way of describing caring. Personal attributes of nurses, family members, and patients themselves are important in the descriptions of the caring process. These attributes are incorporated into the concept of mutuality. CONCLUSIONS: Caring is descriptive of a mutual process in which intentions are joined to form a shared experience. In this mutual process, healing is an outcome that might otherwise be elusive.

Asunto(s)

RESUMEN

Recruitment and Enrollment Assessment in Clinical Trials (REACT), an NHLBI-sponsored substudy of the Cardiac Arrhythmia Suppression Trial (CAST), was conducted to assess factors associated with enrollment in clinical trials. We report on the relationships of institutional factors at CAST sites to patient enrollment. The proportion of CAST-eligible patients enrolling at each CAST site during the REACT study period was defined as the number of subjects enrolled divided by the sum of (1) the number enrolled plus (2) the number of eligibles who refused plus (3) the number of eligibles whose physicians refused to permit CAST personnel to attempt to enroll them. A questionnaire that included 78 questions regarding factors hypothesized to be associated with enrollment was completed between August 1988 and February 1990 by the nurse coordinators at all 112 CAST sites in the United States and Canada. Sixteen items were unanalyzable, and 37 of the remaining 62 were grouped into seven scales. The remaining items were analyzed individually. Enrollment proportions varied widely across the 112 CAST sites (mean 32.7% SD 22.6). Five variables or scales were included in the final multiple regression model (multiple R2 = .39). The most important of these was the proportion of eligible patients at a site cared for by medical staff other than private attending physicians (multiple R2 for this variable alone, .26). This proportion tended to be high in teaching hospitals. Other variables in this model that were associated with higher enrollment proportions included the number of days per week a nurse coordinator was present at the site, the number of nurse coordinator full-time equivalents at the site, fewer other clinical trials for which the nurse coordinator was responsible, and fewer perceived obstacles to enrollment. These findings indicate that enrollment was more successful at hospitals with higher proportions of eligible subjects cared for by fellows, housestaff, and service attending physicians and at institutions with the committed presence of a nurse-coordinator.

Asunto(s)

RESUMEN

The quality of life of 51 elderly subjects enrolled in cardiac rehabilitation is described to devise strategies for improving QOL as an outcome of a therapeutic regimen. Based on Chrisman and Fowler's Systems-in-Change Model, physical function, social function, and emotional function were assessed via the McMaster Health Index Questionnaire and the Cantril Self-Anchoring Scale during participation in cardiac rehabilitation. The greatest benefit of cardiac rehabilitation to subjects was in physical function, but benefits were also noted in social and emotional function.

Asunto(s)

Asunto(s)