Lessons in Medical Record Abstraction from the Prostate, Lung, Colorectal, and Ovarian (PLCO) National Screening Trial.

The most rigorous and accurate approach to evaluating clinical events in cancer screening studies is to use data obtained through medical record abstraction (MRA). Although MRA is complex, the particulars of the procedure-such as the specific training and quality assurance processes, challenges of implementation, and other factors that influence the quality of abstraction--are usually not described in reports of studies that employed the technique. In this paper, we present the details of MRA activities used in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, which used MRA to determine primary and secondary outcomes and collect data on other clinical events. We describe triggers of the MRA cycle and the specific tasks that were part of the abstraction process. We also discuss training and certification of abstracting staff, and technical methods and communication procedures used for data quality assurance. We include discussion of challenges faced and lessons learned.

Prenatal environmental exposures and child health: Minnesota's role in the National Children's Study.

Five medical conditions are responsible for approximately $250 billion in annual health care costs in the United States: obesity, asthma, diabetes, schizophrenia, and autism. For some individuals, these conditions may begin with in utero exposures. However, firm evidence about the links between these conditions and such exposures has yet to be established. The National Children's Study (NCS) is designed to examine how maternal health and the fetal environment are associated with these and other conditions, including birth defects. The NCS will assess how hundreds of social, physical, and environmental exposures affect the health of 100,000 children. The results will provide a data resource from which to develop effective preventive strategies, establish health and safety guidelines, find cures and interventions, influence legislation, and shape public health programs for families and children. The purpose of this article is to describe some of what is known about teratogenesis, how child and adult health can be affected by in utero exposures, and Minnesota's role in the NCS.

False-positive cancer screens and health-related quality of life.

By design, screening tests are imperfect-unresponsive to some cancers (false negatives) while occasionally raising suspicion of cancer where none exists (false positives). This pilot study describes patients' responses to having a false-positive screening test for cancer, and identifies screening effects on health-related quality of life (HRQoL). The pilot findings suggest issues important for incorporation in future evaluations of the impact of screening for prostate, lung, colon, or ovarian (PLCO) cancers. Seven focus groups were conducted to identify the nature and meaning of all phases of PLCO screening. Minnesota participants in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial who had completed screening, with at least 1 false-positive screen, participated (N = 47). Participants' reactions to abnormal screens and diagnostic work-ups were primarily emotional (eg, anxiety and distress), not physical, and ultimately positive for the majority. Health distress and fear of cancer and death were the major negative aspects of HRQoL identified. These concepts are not typically included in generic HRQoL questionnaires like the SF-36, but are highly relevant to PLCO screening. Clinicians were regarded as underestimating the discomfort of follow-up diagnostic testing. However, relief and assurance appeared to eventually outweigh the negative emotions for most participants. Implications for oncology nurses include the need to consider the emotional consequences of screening in association with screen reliability and validity.

A randomized trial of direct mailing of fecal occult blood tests to increase colorectal cancer screening.

BACKGROUND: Although colorectal cancer screening by using a fecal occult blood test (FOBT), flexible sigmoidoscopy, colonoscopy, or barium enema x-ray reduces the incidence of and death from colorectal cancer, the rate of colorectal cancer screening in the general population is low. We conducted a randomized trial consisting of direct mailing of FOBT kits to increase colorectal cancer screening among residents of Wright County, Minnesota, a community in which colorectal cancer screening was promoted. METHODS: At baseline, we mailed a questionnaire about colorectal cancer screening to a random sample of Wright County residents aged 50 years or older who were randomly selected from the Minnesota State Driver's License and Identification Card database (estimated N = 1451). The sample was randomly allocated into three equal subgroups: one group (control) received only the questionnaire, one group received FOBT kits by direct mail with reminders, and one group received FOBT kits by direct mail without reminders. Study participants were sent a follow-up questionnaire 1 year after baseline. We used the responses to the questionnaires to estimate the 1-year change in self-reported screening rates in each group and the differences in the changes among the groups, along with the associated bootstrap 95% confidence intervals (CIs). RESULTS: At baseline, the estimated response rate was 86.5%, self-reported adherence to FOBT guidelines was 21.5%, and overall adherence to any colorectal cancer screening test guidelines was 55.8%. The 1-year rate changes in absolute percentage for self-reported adherence to FOBT use were 1.5% (95% CI = -2.9% to 5.9%) for the control group, 16.9% (95% CI = 11.5% to 22.3%) for the direct-mail-FOBT-with-no-reminders group, and 23.2% (95% CI = 17.2% to 29.3%) for the direct-mail-FOBT-with-reminders group. The 1-year rate changes for self-reported adherence to any colorectal cancer screening test were 7.8% (95% CI = 3.2% to 12.0%) for the control group, 13.2% (95% CI = 8.4% to 18.2%) for the direct-mail-FOBT-with-no-reminders group, and 14.1% (95% CI = 9.1% to 19.1%) for the direct-mail-FOBT-with-reminders group. CONCLUSION: Direct mailing of FOBT kits combined with follow-up reminders promotes more rapid increases in the use of FOBT and nearly doubles the increase in overall rate of adherence to colorectal cancer screening guidelines in a general population compared with a community-wide screening promotion and awareness campaign.

Colorectal cancer screening adherence in a general population.

BACKGROUND: This article describes the self-reported colorectal cancer (CRC) screening adherence rates of adults, aged 50 years and older, living in five nonurban Minnesota counties. METHODS: During the year 2000, 1693 eligible respondents, aged 50 years and older, from a randomly selected sample completed a survey assessing CRC screening adherence (approximately 86.3% response). The survey allowed differentiation between the four CRC screening modalities but did not differentiate between screening and diagnostic testing. Adjustment for nonresponse was performed using a version of Horvitz-Thompson weighting accounting for unknown eligibility. RESULTS: 24.5% of respondents had a fecal occult blood test within 1 year of the survey, 33.8% had flexible sigmoidoscopy within 5 years, 29.3% had a colonoscopy within 10 years, and 13.7% had a barium enema within the last 5 years. Overall, 55.3% of respondents reported testing by any modality; thus, 44.7% were not adherent to screening guidelines. CONCLUSIONS: This study improves on previous attempts to characterize CRC screening adherence by assessing all four modalities of screening as recommended by current screening guidelines, by focusing on nonadherence, and by rigorously accounting for nonresponse. This study confirms that nearly half of the population remains unscreened by any method.