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Biomedical subjects

N M Lane

Publications and source records attributed to N M Lane.

5 recordsLinked to original sources

Computer-based screening of patients with HIV/AIDS for clinical-trial eligibility.

OBJECTIVE: To assess the potential effect of a computer-based system on accrual to clinical trials, we have developed methodology to identify retrospectively and prospectively patients who are eligible or potentially eligible for protocols. DESIGN: Retrospective chart abstraction with computer screening of data for potential protocol eligibility. SETTING: A county-operated clinic serving human immunodeficiency virus (HIV) positive patients with or without acquired immune deficiency syndrome (AIDS). PATIENTS: A randomly selected group of 60 patients who were HIV-infected, 30 of whom had an AIDS-defining diagnosis. DESIGN: Using a computer-based eligibility screening system, for each clinic visit and hospitalization, patients were categorized as eligible, potentially eligible, or ineligible for each of the 17 protocols active during the 7-month study period. Reasons for ineligibility were categorized. RESULTS: None of the patients was enrolled on a clinical trial during the 7-month period. Thirteen patients were identified as eligible for protocol; three patients were eligible for two different protocols; and one patient was eligible for the same protocol during two different time intervals. Fifty-four patients were identified as potentially eligible for a total of 165 accrual opportunities, but important information, such as the result of a required laboratory test, was missing, so that eligibility could not be determined unequivocally. Ineligibility for protocol was determined in 414 (35%) potential opportunities based only on conditions that were amenable to modification, such as the use of concurrent medications; 194 (17%) failed only laboratory tests or subjective determinations not routinely performed; and 346 (29%) failed only routine laboratory tests. CONCLUSIONS: There are substantial numbers of eligible and potentially eligible patients who are not enrolled or evaluated for enrollment in prospective clinical trials. Computer-based eligibility screening when coupled with a computer-based medical record offers the potential to identify patients eligible or potentially eligible for clinical trial, to assist in the selection of protocol eligibility criteria, and to make accrual estimates.

Acquired Immunodeficiency Syndrome↗

A methodology for determining patients' eligibility for clinical trials.

The task of determining patients' eligibility for clinical trials is knowledge and data intensive. In this paper, we present a model for the task of eligibility determination, and describe how a computer system can assist clinical researchers in performing that task. Qualitative and probabilistic approaches to computing and summarizing the eligibility status of potentially eligible patients are described. The two approaches are compared, and a synthesis that draws on the strengths of each approach is proposed. The result of applying these techniques to a database of HIV-positive patient cases suggests that computer programs such as the one described can increase the accrual rate of eligible patients into clinical trials. These methods may also be applied to the task of determining from electronic patient records whether practice guidelines apply in particular clinical situations.

Clinical Trials as Topic↗

Sleep enhanced and irritability reduced in preterm infants: differential efficacy of three types of waterbeds.

The purpose of this study was to determine whether waterbeds enhance preterm infants' sleep and reduce irritability, and whether plain, continuously, or intermittently oscillating waterbeds are differentially effective in producing these effects. The baseline states and motility of 52 stable preterm infants were assessed on two consecutive days for 100 minutes each. The infants then were randomly assigned to four groups: a control group who remained on the incubator mattress, or to one of the three experimental groups, each using a different waterbed. On days 3 and 4 in the assigned test condition, the infants' states and motility were again assessed for 100 minutes each day. The results indicate that, compared with infants in the control group, infants assigned to any of the waterbed groups slept significantly more and better, had significantly fewer unsmooth movements, state changes, and transitional states, and were significantly less irritable. Differential treatment effects were found, with infants on continuously oscillating waterbeds showing the most marked reductions in irritability, restlessness, state changes, and unsmooth movements. Thus, to enhance restful sleep and to reduce irritability and/or restlessness, it would be clinically advantageous to use waterbeds in the care of preterm infants. Since even the simple, nonoscillating waterbed improved sleep and reduced restlessness, the use of these beds would be the least costly to achieve these effects.

Arousal↗

Stable individual differences in developmentally changing preterm infants: a replicated study.

In a longitudinal study with the Neurobehavioral Maturity Assessment (NB-MAP), developmental changes and stability of individual differences were assessed in 2 independent samples of preterm infants ranging from 32 weeks conceptional age to term. Individual stability of response was assessed using regression analysis with repeated measures on subjects. The large majority of the functions tested showed highly significant developmental gains with age and highly significant individual stability of performance across age. These findings replicated well across the 2 cohorts. The results are discussed in the light of the neurobiological stage of development of preterm infants during the last 8 weeks prior to term.

Humans↗