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PubMed2006

Clinical trials update from the European Society of Cardiology heart failure meeting: TNT subgroup analysis, darbepoetin alfa, FERRIC-HF and KW-3902.

This article provides information and a commentary on trials relevant to the pathophysiology, prevention and treatment of heart failure, presented at the European Society of Cardiology heart failure meeting held in June 2006. All reports should be considered as preliminary data, as analyses may change in the final publication. In a sub-group analysis of the TNT study, intensive treatment with high-dose atorvastatin significantly reduced hospitalisations for heart failure in patients with stable coronary heart disease, compared with low-dose atorvastatin; this benefit was most evident in patients with a history of heart failure at baseline. In a combined analysis of two studies of darbepoetin alfa, which included 475 patients, treatment increased and maintained haemoglobin levels and produced non-significant improvements in symptoms and morbidity in anaemic heart failure patients compared to placebo. In the FERRIC-HF study (n=35), intravenous iron sucrose therapy improved exercise capacity and symptom status in iron-deficient heart failure patients. In a combined analysis of two studies (n=186), the adenosine A(1) receptor antagonist KW-3902 showed diuretic properties and appeared to enhance response to loop diuretics in heart failure patients hospitalised with fluid overload.

Anemia↗
PubMed2002

The EORTC Breast Cancer Group: 40 years of research contributing to improve breast cancer management.

The EORTC Breast Cancer Group (EBCG) is a multidisciplinary international group created in 1962 in conjunction with the EORTC. This group has always focused its activities on the development of new cancer treatments and strategies for all categories of breast cancer. It has been active both in drug development, as well as in the development of new radiotherapy and surgical techniques to attempt to improve cure rates and loco-regional control. Over 40 years, the EBCG has performed dozens of clinical studies including several thousands of patients. Many of these studies have contributed to the clinical knowledge on the treatment of breast cancer and have influenced the standard management of this tumour. Beside its clinical research activities, the Group has also been very active in developing guidelines for breast cancer research, promoting high standards of care in conferences, as well as in fellowships and quality assurance programmes. EBCG is a founding member of the Breast InterGroup (BIG).

Breast Neoplasms↗
PubMed2000

Minority recruitment in clinical trials: a conference at Tuskegee, researchers and the community.

PURPOSE: This article describes the planning, implementation, and evaluation of a 2-day conference designed to examine the factors related to the participation of African Americans in cancer clinical trials. METHODS: Pre-conference formative evaluations (e.g., focus group discussions and key informant interviews with community leaders and health providers) were conducted in several rural and urban counties in the state of Alabama to determine African Americans' perceptions of participation in clinical research. The findings from these evaluations were used to develop a conference format and agenda. The 2-day conference included: (i) a pretest of African Americans' perceptions of cancer research, participation factors, and communication and recruitment issues; (ii) individual presentations high-lighting community leaders, church leaders, and researchers' perspectives regarding minority participation in research; (iii) working group discussions regarding the barriers and solutions to minority participation in research; and (iv) a posttest evaluation to measure changes in African Americans' perceptions of research. RESULTS: Several recruitment barriers and solutions were identified and reported by the working groups. Comparisons of the pretest and posttest measures showed significant (p > .05) and favorable shifts in the areas of perceptions of cancer research, participation factors, communication issues, and recruitment issues. Participation in the conference reflected a positive change in attitudes on these measures. However, the theme, "barriers that contributed to nonparticipation," did not show any significant changes during the two testing periods. The most critical lesson that resulted from this conference was the need for researchers and community members to have open dialogue about participation in research. CONCLUSIONS: This conference demonstrated that progress can be made when all parties are at the "table" and can be heard. In this model, community members proved to be valuable resources in providing researchers with information that was vital to the success of recruitment and retention studies and trials.

Black or African American↗
PubMed2003

Toward complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

RATIONALE AND OBJECTIVES: To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, and analysis of such studies. The authors sought to develop guidelines for improving the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers better to assess the validity and generalizability of study results. MATERIALS AND METHODS: The Standards for Reporting of Diagnostic Accuracy group steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and to extract potential guidelines for authors and editors. An extensive list of items was prepared. Members of the steering committee then met for 2 days with other researchers, editors, methodologists, statisticians, and members of professional organizations to develop a checklist and a prototypical flowchart to guide authors and editors of studies of diagnostic accuracy. RESULTS: The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which the group produced an initial list of 75 items. This list was honed to 25 key items by group consensus and on the basis of published research on bias. A prototypical flowchart was developed as a tool for conveying information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation, the reference test, or both. Potential users reviewed the conference version of the checklist and flowchart and provided additional suggestions, which were then incorporated. CONCLUSION: Use of these carefully developed, consensus-based guidelines should enable clearer and more complete reporting of studies of diagnostic accuracy, as well as better reader understanding of the validity and generalizability of study results.

Bias↗