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This report provides results of an analysis of temporal trends in childhood cancer incidence in the U.S. stratfied by age, sex, and to a lessor extent, race, within common histologic subtypes. Population-based data from nine registries of the Surveillance, Epidemiology, and End Results Program of the National Cancer Institute were analyzed. The analysis was limited to children age < or = 14 years. Cancer cases were restricted to those patients with a malignant neoplasm diagnosed between 1974 and 1991; more than 12,000 children were included. Average annual percentage change in incidence rates and corresponding 95% confidence intervals were estimated from the maximum likelihood method of Poisson regression. Among children age < or = 14 years there was a 1% average yearly increase (95% CI 0.6, 1.3) in the incidence rates of all malignant neoplasms combined. The average annual percentage change was similar for males and females, and slightly higher for black children compared with white children. Rates increased an average of 2% or more per year for astroglial tumors, rhabdomyosarcomas, germ cell tumors, and osteosarcomas. The average annual percentage change for acute lymphoid leukemia was 1.6% and trends were somewhat stronger for blacks than whites. Cancer trends, in general, were strongest in young children. In particular, increases in astroglial tumors and rhabdomyosarcomas were most apparent among children age < 3 years, and for retinoblastoma and neuroblastoma among children in their first year of life. The average annual percentage change for acute lymphoid leukemia did not vary dramatically with age, however children age < 2 years had stronger trends compared with older children. We found little evidence for increasing trends in Wilms' tumor, primitive neuroectodermal tumors, or hematopoietic neoplasms other than acute lymphoid leukemia. These results suggest that cancer occurrence among children within specific histologies increased modestly in the U.S. between 1974 and 1991, and that the increases were most apparent among young children.
This study was conducted to assess the readability of informed consent forms that describe clinical oncology protocols. One hundred thirty-seven consent forms from 88 protocols that accrued patients at The Johns Hopkins Oncology Center were quantitatively analyzed. These included 58 of 99 (59%) institutional protocols approved by The Johns Hopkins Oncology Center's Clinical Research Committee and the Institutional Review Board (IRB) over a 2-year period, and 30 active Eastern Cooperative Oncology Group (ECOG), Radiation Therapy Oncology Group (RTOG), and Pediatric Oncology Group (POG) trials. The consent forms described phase I (17%), phase I/II (36%), phase III (29%), and nontherapeutic (18%) studies. Each was optically scanned, checked for accuracy, and analyzed using readability software. The following three readability indices were obtained for each consent form: the Flesch Reading Ease Score, and grade level readability as determined by the Flesch-Kincaid Formula and the Gunning Fog Index. The mean +/- SD Flesch Reading Ease Score for the consent forms was 52.6 +/- 8.7 (range, 33 to 78). The mean grade level was 11.1 +/- 1.67 (range, 6 to 14) using the Flesch-Kincaid Formula and 14.1 +/- 1.8 (range, 8 to 17) using the Gunning Fog Index. Readability at or below an eighth-grade level was found in 6% of the consent forms using the Flesch-Kincaid Formula and in 1% using the Gunning Fog Index. Readability was similar for consent forms that described institutional, cooperative group, and phase I, II, and III protocols. Consent forms from clinical oncology protocols are written at a level that is difficult for most patients to read, despite national, cooperative group, institutional, and departmental review. The consent process, which is crucial to clinical research, should be strengthened by improving the readability of the consent forms.
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