Admissibility of scientific evidence post-Daubert.

Proof of medical causation is the key element in cases involving alleged radiation injury. Until 1993, the use of scientific testimony in the courtroom was governed by the Frye doctrine requiring that a theory be "generally accepted" before it can be the basis of an expert's opinion. Applying that rule trial courts adopted a "let it all in" approach resulting in a near overdose of pseudoscience presented to juries. With its decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786 (1993), the U.S. Supreme Court announced a new five-factor, non-exclusive test for federal district courts to consider when assessing the opinion of scientific experts. The Court further directed that the trial courts, acting as a gatekeeper for expert evidence, must evaluate whether there is an adequate "fit" between the expert's data and the opinion offered. This article examines how the Daubert standard has been implemented in federal court to combat junk science. Examples from recent case law dealing with operational health physics issues are presented as an illustration of the use of the five-factor test to challenge questionable testimony on causation. Guidance is offered to prospective expert witnesses in radiation-related litigation to insure that proposed testimony will be admissible in district court.

A pilot coping improvement intervention for late middle-aged and older adults living with HIV/AIDS in the USA.

As AIDS becomes more prevalent among late middle-aged and older adults, mental health support services that facilitate the coping and adjustment efforts of this group are increasingly needed. The current article: (1) outlines a coping improvement group intervention for HIV-infected older adults; and (2) examines the efficacy of the intervention utilizing a small sample (N = 16) of older adults living with HIV/AIDS in Milwaukee, Wisconsin and New York City. The intervention focused on enabling HIV-infected older adults to accurately appraise sources of stress, develop adaptive coping responses and access social support resources to facilitate coping efforts. An evaluation of this pilot intervention, conducted using a pretest-posttest, no control group design, revealed that the intervention increased participants' perceptions of social support, produced higher perceptions of social wellbeing and enabled participants to engage in more planful problem solving, confrontive coping and future optimism. Intervention participants also experienced less stressor burden associated with AIDS-related loss and health concerns. While the current intervention showed potential to facilitate the adjustment efforts of HIV-infected older adults, randomized clinical trials of this intervention with larger samples are needed before its appropriateness for this population can be determined.

Late middle-aged and older men living with HIV/AIDS: race differences in coping, social support, and psychological distress.

Although AIDS mental health research has recently devoted more attention to the psychosocial needs of older adults living with human immunodeficiency virus (HIV) disease, studies of this population have typically combined older African-American and white participants into one large sample, thereby neglecting potential race differences. The current study examined race differences in stressor burden, ways of coping, social support, and psychological distress among late middle-aged and older men living with HIV/AIDS. Self-administered surveys were completed by 72 men living with HIV/AIDS in New York City and Milwaukee, WI (mean age = 53.4 years). Older African-American and white men experienced comparable levels of stress associated with AIDS-related discrimination, AIDS-related bereavement, financial dilemmas, lack of information and support, relationship difficulties, and domestic problems. However, in responses to these stressors, older African-American men more frequently engaged in adaptive coping strategies, such as greater positive reappraisal and a stronger resolve that their future would be better. Compared to their African-American counterparts, HIV-infected older white men reported elevated levels of depression, anxiety, interpersonal hostility, and somatization. African-American men also received more support from family members and were less likely to disclose their HIV serostatus to close friends. As AIDS becomes more common among older adults, mental health-interventions will increasingly be needed for this group. The development of intervention programs for this group should pay close attention to race-related differences in sociodemographic, psychosocial, and behavioral characteristics.

Building a solid GLP foundation: implementing shared training programs between the QAU and study personnel.

Quality assurance representatives and study personnel are equally responsible for conducting preclinical studies in compliance with good laboratory practices (GLPs). To provide all employees with a solid understanding of GLP requirements we have implemented a system of shared training programs for the quality assurance unit (QAU) and study personnel. Biologists and chemists complete a three-phase training module that encompasses GLP history, roles and responsibilities of the QAU, and QAU procedures specific to Wildlife International, Ltd. Study directors work with experienced QA trainers and are provided mock auditing assignments, including data, reports, and in-process and facility inspections. QA personnel are in turn trained by qualified study personnel in principal scientific concepts, testing guidelines, and study procedures that will be observed when performing in-process inspections and data audits. Also, as permanent positions become available, selected individuals from the QAU may assume responsibilities in various departments as study directors or laboratory supervisors, and study directors may assume responsibilities as quality assurance representatives. At Wildlife International, Ltd., these shared training programs provide a mutual understanding and knowledge of GLP requirements and their application while promoting respect and harmony between the QAU and study personnel.

Customized dual data entry for computerized data analysis.

A major responsibility of any Quality Assurance Unit (QUA) is to ensure data integrity. Errors made during data entry can lead to many problems in the study review process and decrease the quality, accuracy, and overall efficiency of data management. One technique that can reduce the number of data entry errors in computer data sets is the use of a dual entry data system. Currently available software allows creation of customized data entry screens that either closely resemble or duplicate the data collection forms used during studies. Two data entry operators enter data into two independent data sets. The use of an on-screen display that resembles the data collection form reduces the potential for keypunch errors. The two data sets can then be electronically compared. The comparison reports differences between the two data sets. When differences exist, the correct values can be determined by reference to the original data sheets and the two data files can then be corrected. Theoretically, the only key punch errors that will exist after making these corrections are when the two independent entry operators make the same exact data entry error. Typically, the time required for two people to enter data is minimal compared to the time required to manually identify and correct data entry discrepancies. With error-free data entry, we have found that electronic data quality, accuracy, and audit efficiency are improved at every subsequent step of data management, analysis, quality assurance auditing, and report generation.

The critical phase inspection process: a benchmarking study in search of industries' best practices.

Benchmarking is the orderly process of measuring one's own products, services, and practices against those of companies recognized as leaders. Eli Lilly and Company's Quality Assurance Department formed the Critical Phase Inspection Team to benchmark the processes for selecting and conducting critical phase inspections and reporting inspection findings. The team developed a telephone survey that was conducted with 33 other quality assurance units across the country. Analysis of the phone survey responses resulted in the identification of 5 quality assurance units that we felt could provide valuable information to us on these activities. Site visits to these companies were arranged and information was shared. We present here the analysis and results of our benchmarking endeavor. Through the information sharing involved in the benchmarking process, namely, the telephone surveys and the site visits, fresh ideas emerged and new acquaintances were made. Comparisons and adaptations of our methods with others in the quality assurance business will lead us to breakthrough improvements that will allow us to improve our current processes.