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PubMedDate not supplied

Testing of central nervous system shunt devices.

This paper presents the results of a study performed by the U.S. Food & Drug Administration (FDA) under the Conformance Assessment to Voluntary Standards program. The ASTM voluntary standard F647-85 (American Society for Testing and Materials: Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurological Applications) was evaluated as to the adequacy of its test methods and the reasonableness of its application to currently marketed shunt devices. The objective of this study was to assess the impact of ASTM: F647-85 on the safety and effectiveness of shunt devices and thereby assist the FDA in setting priorities for its mandatory standards development activities. By searching the FDA's postmarketing surveillance database and by testing seventeen shunt devices and three catheters from six manufacturers, it was determined that these devices conform with most of the ASTM standard requirements. However, no single device conformed to all of the requirements of the standard. Suggestions for improving the voluntary standard's impact on the safety of shunt devices are presented.

Central Nervous System↗
PubMedDate not supplied

Factors associated with attendance in a voluntary nutrition education program.

PURPOSE: This paper examines factors associated with attendance in a National Cancer Institute-funded randomized trial of nutrition education to increase fruit and vegetable consumption among women served by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). SETTING: The study took place at 16 WIC sites in Maryland. SUBJECTS: The participants were 1528 women who were enrolled in WIC or who had children enrolled in WIC, were > or = 18 years of age, and planned to continue enrollment at that WIC site for at least 6 months (68% of eligible women approached agreed to participate). INTERVENTION: Women received personal invitations, letters, and telephone reminders from peer educators encouraging their attendance at three bimonthly nutrition sessions. MEASURES: Demographic data were collected in a baseline survey. Attendance data and telephone and address changes were also collected. The postintervention survey included a question regarding reasons for nonattendance. Focus groups were also held to ascertain reasons for attendance or nonattendance. Chi-square tests of trend and multiple logistic regression, adjusted for within-site correlation, were used in statistical analyses. RESULTS: Fifty-four percent of enrollees attended at least one session. Multiple logistic regression analysis showed increased odds of attending with higher age, breast-feeding, and/or knowledge of the recommendation to eat five or more servings of fruits and vegetables daily. There were decreased odds of attending for pregnant women who already had children. There were nonsignificant trends toward decreased attendance among unmarried women compared with married women and among blacks compared with nonblacks. Reasons given for nonattendance included withdrawal from WIC, moving, conflicting activities, negative feelings about nutrition education, and lack of transportation or child care. CONCLUSIONS: The results suggest that numerous barriers hinder participation in nutrition programs aimed at low-income women. These barriers should be considered by health care professionals when planning intervention programs. Overcoming these barriers presents a major challenge.

Adolescent↗