Marguerite R. Kinney

Clinical trial enrollers vs. nonenrollers: the Cardiac Arrhythmia Suppression Trial (CAST) Recruitment and Enrollment Assessment in Clinical Trials (REACT) project.

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 patients reading of the informed consent form and the patients lack of medical insurance. These results suggest that (1) the clinical trial staffs 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.

Quality of life in cardiac patient research: a meta-analysis.

This article reports a meta-analysis of 84 studies of quality of life (QOL) in cardiac patient populations published in the 5-year period 1987-1991. Selected methodologies and substantive characteristics of the studies are described. An overall effect size of .31 indicated a small but significant positive effect of pharmacologic, mechanical, surgical, nursing, or other treatment on QOL. No negative effect of treatment was found for any cardiovascular diagnostic category. Homogeneity analysis revealed eight potential moderators of the overall effect size: quality of study, gender of sample, time dimension, sampling method, intervention, marital status of subjects, quality-of-life dimension measured, and sample size.

Enrollment in clinical trials: Institutional factors affecting enrollment in the Cardiac Arrhythmia Suppression Trial (CAST)

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.

The abdomen, thigh, and arm as sites for subcutaneous sodium heparin injections.

The purpose of this study was to evaluate three subcutaneous injection sites for low-dose heparin therapy (5,000 units). One hundred and one subjects were randomly placed in one of three groups. Group A received injections in the abdomen, Group B, in the thigh, and Group C in the arm. Each subject received three injections at the one site. Activated partial thromboplastin time (APTT) was measured prior to initiation of heparin and again four hours after the first injection. Bruising was measured at 48, 60, and 72 hours postinjection. There were no statistically significant differences among groups for either changes in APTT or bruising at 60 and 72 hours postinjection. Thus the clinical practice of utilizing the abdomen as the only or preferred site for subcutaneous heparin injections was not supported.

Quality of life of elderly patients enrolled in cardiac rehabilitation.

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 Fowlers 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.

A methodology for validating nursing diagnoses.

A methodologic approach consisting of four phases is proposed for validating nursing diagnoses. The sequential phases include use of the Delphi technique, magnitude estimation scaling, patient observation, and testing nursing interventions through clinical trials. The proposed methodologic approach is a strategy for researching the diagnosis and treatment of human responses to actual or potential health problems—the foundation for nursing practice.

Presurgical risk factors for late extubation in medicare recipients after cardiac surgery

BackgroundMedicare recipients, particularly those 80 years of age and older, are increasingly undergoing coronary artery bypass grafting surgery (CABGS). There is an association between older age and need for prolonged mechanical ventilation (MV); however, it is unclear what other presurgical characteristics may contribute to prolonged time on the ventilator in older adults. ObjectiveTo develop and validate a probability model for prolonged MV utilizing selected presurgical patient characteristics. MethodA retrospective, nonexperimental design was utilized to study 548 Medicare recipients (65 years of age or older) undergoing CABGS during 1998. Data were obtained from an existing coronary artery surgery clinical database. ResultsBased on extubation time, the sample was comprised of two groups (Group 1, N = 205; MV ≤ 5 hours. Group 2, N = 343; MV > 5 hours). Using logistic regression modeling, predictors of late extubation included: (a) age of 80 years or older (odds ratio [OR] 2.99, p = .003), (b) female sex (OR = 1.76, p = .011), (c) hypertension (OR = 1.60, p = .018), (d) urgent or emergent preoperative clinical status (OR = 3.04, p = .002), and (e) prior CABGS (OR = 2.14, p = .009). The predictive model provided moderate discrimination of time to extubation group (concordance statistic = 0.656). ConclusionsOlder age, urgent or emergent preoperative clinical status, and prior CABGS are risk factors for prolonged MV, which have been consistently identified in combined adult and older adult samples. Female sex and hypertension have not been well supported in earlier studies as risk factors for prolonged MV. The exploratory model provides a preliminary indication of factors placing Medicare recipients at risk for late extubation, but requires further development and testing for use by nurses in clinical practice.

Clinical referents for nursing diagnoses.

&NA; Validation of nursing diagnoses is an essential step in developing knowledge for nursing practice and should be a major goal of the discipline. Nursing diagnoses must have clinical referents, that is. defining characteristics which appear in patient populations exhibiting specific nursing diagnoses. Selecting nursing diagnoses for patient populations, developing a list of defining characteristics and operational definitions for a nursing diagnosis, selecting a standard to discriminate among subjects and constructing an instrument to document the occurrence of defining characteristics in selected patient populations are preliminary steps in identifying clinical referents. Methodological concerns addressed in establishing clinical referents for nursing diagnoses included controlling confounding factors, determining sample size, conducting a pilot study, determining interrater reliability, selecting appropriate statistical tests, and identifying critical defining characteristics for a nursing diagnosis.

Using Conceptual Frameworks or Models to Guide Nursing Research

To be useful, a frame of reference must enable an investigator to organize all components of a research study beginning with the literature review and problem statement and continuing through interpretation of findings. Careful conceptualization of the entire research process will move nurses closer to building an orderly system of scientific knowledge in which each investigation serves as a tool of nursing science.

Assessing data adequacy for clinical research: reliability and validity of a surgical database.

As clinical databases are utilized more frequently for clinical research, it is essential that researchers assess the quality of databased information. While researchers have begun to report strategies to measure accuracy of databased information, knowledge remains limited. The purpose of this study was to assess the reliability and validity of databased information among selected study variables contained within a computerized coronary artery surgery clinical database using the written patient medical record as an external standard. Both reliability (N = 400) and validity (N = 100) samples were randomly selected from a databased sampling frame of 548 Medicare subjects who underwent coronary artery bypass grafting surgery in 1998. Reliability assessed by consistency rates were age (95%), race (94%), gender (99%), congestive heart failure (CHF) (60.5%), angina (91.5%), renal insufficiency (82%), hypertension (91.7%), diabetes mellitus (93.7%), chronic obstructive pulmonary disease (COPD) (75.5%), clinical status (97%), American Society of Anesthesiologists classification (99%), prior peripheral vascular surgery (15.5%), prior CABGS (99%), and duration of mechanical ventilation (87.5%). These percentages reflected a large portion of missing data for CHF, COPD, and prior peripheral vascular surgery. Validity assessed by sensitivity and specificity analyses were all greater than 80%. The majority of computerized databased information among selected study variables was the same information recorded in the written patient medical record. Using the same external standard to assess both reliability and validity was a significant limitation of this study, which resulted in the same measure of data adequacy by utilizing differing statistical methods.