The Role of the Clinical Research Coordinator in Multicenter Clinical Trials

The clinical research coordinator plays a crucial role in organizing a site's participation in the expanding arena of multicenter medical and pharmacologic clinical trials. This summary clarifies the role of the clinical research coordinator for inexperienced staff members assuming these responsibilities and outlines planning procedures leading to successful implementation. Emphasis is placed on establishing an interdependent relationship with the principal investigator, careful protocol assessment, team building, and staff feedback. Useful tools such as study manuals and physicians' study orders are described.     

Indwelling Versus Intermittent Feeding Tubes in Premature Neonates

Objective: To determine the effect of indwelling versus intermittent feeding tube placement on weight gain, apnea, and bradycardia in premature neonates.
Design: Eligible subjects were assigned randomly to either feeding tube method. Each subject was followed for 6 days.
Setting: The study was conducted in a secondary level neonatal intensive-care unit (NICU), a tertiary level NICU in a perinatal center, and a tertiary level NICU in a referral center.
Patients/Participants: Neonates who were 24–34 weeks gestational age, developmentally appropriate for gestational age, medically stable, on full enteral feedings through an orogastric or a nasogastric tube, and not fluid restricted. Ninety-three neonates were enrolled-49 in the indwelling group and 44 in the intermittent group. Nine neonates did not complete the study.
Interventions: Nasogastric indwelling feeding tubes were placed and left in site for up to 3 days. Orogastric intermittent feeding tubes were placed for each feeding and removed at completion of the feeding.
Main outcome measures: Weight gain, apnea, and bradycardia. Results: Members of both groups had similar demographic characteristics, clinical problems, and nutritional intake. No statistical differences were found between the two groups in weight gain or episodes of apnea and bradycardia.
Conclusions: There were no statistically or clinically significant differences between the two groups. The intermittent method of feeding is more expensive. Because no clinical differences were found, the type of tube placement chosen for feeding the premature infant may be based on economics.     

Preconditions for and consequences of self-determination: the psychiatric patient's point of view

In the context of an interview study concerned with self-determination in psychiatric patients, this paper describes the preconditions for and consequences of self-determination from the point of view of psychiatric patients themselves. The data were collected in semi-structured interviews with long-term psychiatric patients ( n =72) and analysed using the method of content analysis. Responses on the preconditions for self-determination were grouped into three categories: firstly, there were those who said that reference to self-determination in the case of psychiatric patients is nonsense; secondly, there were those who said that self-determination requires no preconditions; and thirdly, there were those who said that there are certain preconditions, such as the ability to think and make decisions, activity, obedience, and illness. Both positive and negative consequences were identified in situations where self-determination is maintained, but only negative consequences in situations where self-determination is lost. On the basis of these tentative results, self-determination seemed to be relevant in psychiatric nursing. We are continuing to develop and test an instrument for the evaluation of the opportunity for self-determination in clinical practice.     

The life situation of a long-term psychiatric patient: some restrictions in, and possibilities of, open care

This paper describes and analyses, from a sociocultural viewpoint, the ways of life of discharged long-term psychiatric patients in northern Finland The paper focuses on subjectivity control of life and fundamental experiences in life The data consist of interviews with 25 outpatients who have moved to live in residential homes, rehabilitation centres or their own homes after receiving preparatory training in the psychiatric hospital The findings suggest that the way of life of the outpatients did not significantly differ from that of other people belonging to the same generation of Finns With respect to control of life, a conspicuous feature was the strong tendency to let themselves be led by others, and to self-sacrifice for the good of others For the patients, independence was the best aspect of open care Fear for being branded as a psychiatric case or as a former mental patient threatened the patients'external control of life The central element of control of life of the Finns is work The outpatients thought work a matter of honour and they did not find their present, inactive way of life satisfactory     

Developing a Documentation System That Works

A documentation system that facilitates accurate and complete recording is needed by every obstetric/neonatal nursing service. Developing an individualized system is a major undertaking. However, specific steps can be taken to ease the process. These steps are described, beginning with the assessment phase and concluding with evaluation.