Japan's contribution to research on cardiovascular disease.
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Japan's contribution to the research on cardiovascular disease in the past decade was analyzed by accessing journal articles published in 1991-2000 in the MEDLINE database. The number of articles having an affiliation with a Japanese institution was counted and summed up as a whole and also separately for each journal with statistical time trend analysis. The proportions of randomized controlled study (RCT), case - control/cohort study, and case reports in articles from Japan were also determined. Of the total articles, Japan's contribution to the research on cardiovascular disease was 8.9% and ranked 2nd in the world. The recent increase in the contribution was not significant (p=0.25). Compared with other countries, the proportions of RCT (2.3%) and case - control/cohort study (2.3%) were smaller and that of case reports was similar (5.7%). Although the overall contribution from Japan in the field of cardiovascular disease is satisfactory, high-quality clinical research is as meager as in other clinical fields. (+info)
Handheld computing in medicine.
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Handheld computers have become a valuable and popular tool in various fields of medicine. A systematic review of articles was undertaken to summarize the current literature regarding the use of handheld devices in medicine. A variety of articles were identified, and relevant information for various medical fields was summarized. The literature search covered general information about handheld devices, the use of these devices to access medical literature, electronic pharmacopoeias, patient tracking, medical education, research, business management, e-prescribing, patient confidentiality, and costs as well as specialty-specific uses for personal digital assistants (PDAs). The authors concluded that only a small number of articles provide evidence-based information about the use of PDAs in medicine. The majority of articles provide descriptive information, which is nevertheless of value. This article aims to increase the awareness among physicians about the potential roles for handheld computers in medicine and to encourage the further evaluation of their use. (+info)
Do they understand? (part I): parental consent for children participating in clinical anesthesia and surgery research.
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BACKGROUND: Central to the tenet of informed consent is the quality of disclosure of information by the investigator and the understanding thereof by the research subject or his or her surrogate. This study was designed to measure parents' understanding of the elements of informed consent for clinical studies in which their children had been approached to participate. METHODS: The study sample consisted of 505 parents who had been approached for permission to allow their child to participate in a clinical anesthesia or surgery study. Regardless of whether the parent consented (consenters, n = 411) or declined (nonconsenters, n = 94) to their child's participation in a study, they were interviewed to determine their understanding of 11 elements of consent. Two independent assessors who were familiar with the study protocols scored the parents' levels of understanding. RESULTS: Parents perceived their overall understanding of the elements of consent as high (8.7 +/- 1.6; 0-10 scale); however, this represented a significant overestimation compared with the assessors' measures of parental understanding (7.3 +/- 1.8; P< 0.0001). Furthermore, consenters had greater understanding than nonconsenters (7.6 +/- 1.6 vs 6.1 +/- 1.9; P< 0.001). Several predictors of understanding were identified, including whether the parent consented, education level, clarity of disclosure, child in previous study, age of parent, parent listened to disclosure, and degree to which parent read the consent document. The day on which consent was sought had no impact on the level of understanding. CONCLUSIONS: Parents approached for permission to allow their child to participate in a research study had less than optimal understanding of the elements of consent. As such, investigators must make every effort to enhance understanding and ensure that parents have sufficient information to make informed decisions regarding their child's participation in research studies. (+info)
Do they understand? (part II): assent of children participating in clinical anesthesia and surgery research.
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BACKGROUND: Participation of children in clinical research requires not only parental permission but also the assent of the child. Although there is no fixed age at which assent should be sought, investigators should obtain assent from children considered able to provide it. This study was designed to determine children's understanding of the elements of disclosure for studies in which they had assented to participate. METHODS: The study population included 102 children aged 7-18 yr who had given their assent to participate in a clinical anesthesia or surgical study. Children were interviewed using a semistructured format to determine their understanding of eight core elements of disclosure for the study to which they had agreed to participate. Two independent assessors scored the children's levels of understanding of these elements. RESULTS: The children's perceived level of understanding of the elements of disclosure was significantly greater than their measured understanding (7.0 +/- 2.4 vs 5.3 +/- 2.7, 0-10 scale; P< 0.0001). Complete understanding of the elements of disclosure for all children ranged from 30.4 to 89.4%. Children aged more than 11 yr had significantly greater understanding compared with younger children, particularly with respect to understanding of the study protocol, the benefits, and the freedom to withdraw. CONCLUSIONS: Children approached for their assent to participate in a clinical anesthesia or surgery study have limited understanding of the elements of disclosure and their role as a research participant, particularly if they are aged less than 11 yr. (+info)
Public attitudes toward participation in cancer clinical trials.
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PURPOSE: The objective of this study is to understand the attitudes of American adults toward participation in cancer clinical trials. METHODS: A national probability sample of 1,000 adults aged 18 and older living in noninstitutional settings was interviewed by telephone by Harris Interactive during March and April 2000. One participant was selected from each household selected for the study. The resulting data were weighted to reflect the full adult population of the United States as reported in Current Population Reports. An Index of Participation in a Cancer Clinical Trial was computed, using a confirmatory factor analysis and converting the factor scores into a 0-to-100 scale. RESULTS: Approximately 32% of American adults (64 million individuals) indicate that they would be very willing to participate in a cancer clinical trial if asked to do so. An additional 38% of adults (76 million individuals) scored in a range that indicates that they are inclined to participate in a cancer clinical trial if asked, but hold some questions or reservations about participation. Projected rates of diagnosis, eligibility, and recruitment indicate that substantially more patients are willing to participate than are actually accrued. CONCLUSION: These results indicate that the primary problem with accrual is not the attitudes of patients, but rather that the loss of potential participants is the result of the unavailability of an appropriate clinical trial and the disqualification of large numbers of patients. The pool of willing patients is further reduced by the reluctance of some physicians to engage in accrual. (+info)
25th Annual San Antonio Breast Cancer Symposium, San Antonio, Texas, USA, 10-14 December 2002 Update on clinical research.
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The Annual San Antonio Breast Cancer Symposium has become a key forum for the presentation and discussion of both translational scientific aspects as well as clinical aspects of breast cancer care. In this report of the 25th Annual Meeting, an update of the salient clinical data is presented. The findings of the CALGB 9741 trial, an updated analysis of the Arimidex, Tamoxifen, Alone or in Combination study, and other significant paper and poster presentations are discussed. Summaries are also given of the clinical plenary lectures and minisymposia on adjuvant therapy and aromatase inhibitors. (+info)
Impact of biomedical research on African Americans.
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Pharmaceutical development and medical research continues at a fevered pitch. Historically, however, African Americans and other minorities have not been adequately represented in the studies determining a drug's safety and efficacy in humans. A history of misuse in the medical research systems (most notably the Tuskeegee study of syphillis in a population of illiterate, poor black men) have left many blacks wary of the health care system. However, attempts to address the health disparities faced by African Americans must include processes for including wider representation of blacks--as patients as well as investigators--in clinical trials. (+info)
Embryo donation for medical research: attitudes and concerns of potential donors.
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BACKGROUND: The recent derivation of embryonic stem cell lines from human blastocysts and related implications for regenerative medicine has intensified a longstanding debate about the use of human embryos for research purposes. However, studies have shown that few couples with stored embryos opt to donate them for research. Herein, the attitudes and concerns of potential embryo donors to donation of surplus embryos for medical research were examined. METHODS: From a total of 509 couples who had stored frozen embryos and who had received a questionnaire about embryo donations for medical research, 152 women (30%) and 123 male partners (24%) responded. Embryos had been stored for a mean of 2.25 years (range 3 months to 12 years). RESULTS: Some 10% of respondents indicated it probable, and 34% possible, that they would donate their surplus embryos for research in the future. Women respondents whose embryos had been stored longer, and those committed to the practice of a religion, were more worried about their embryos. Respondents positively disposed to donation commented on their desire not to waste embryos, a desire to help infertile couples, and/or to advance scientific knowledge. Those with negative views commented on the embryo as a potential child and expressed concerns about a perceived lack of control over the type of research to be carried out. CONCLUSIONS: Findings indicate a need for tailored education and counselling about embryo donation for medical research. (+info)