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PubMed | Triangle Park, Li Ka Shing Knowledge Institute, Johnson & Johnson, University of California at San Francisco and 12 more.
Type: Journal Article | Journal: Revista panamericana de salud publica = Pan American journal of public health | Year: 2016

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.


Iqbal J.,Womens College Research Institute Womens College Hospital | Ginsburg O.,Womens College Research Institute Womens College Hospital | Ginsburg O.,University of Toronto | Giannakeas V.,Womens College Research Institute Womens College Hospital | And 6 more authors.
Breast Cancer Research and Treatment | Year: 2016

Purpose: The clinical significance of nodal micrometastasis is debated. Our primary objective was to determine whether, among women with early-stage breast cancer, regional lymph node micrometastasis is an independent risk factor for mortality. The secondary objective was to identify subgroups of women who have the highest risk of death from early-stage breast cancer with micrometastases. Methods: 206,625 women diagnosed with early-stage breast cancer (IA, IB, and IIA) from 2004 to 2012 were identified in the Surveillance, epidemiology, and end results database. Nodal status was classified as node-negative, isolated-tumor cells, micrometastases, and macrometastases. Women were classified into eight ethnic groups. Logistic regression was performed to estimate the odds ratio of being diagnosed with micrometastases. The Cox proportional hazard model was used to estimate the hazard ratio (HR) of breast cancer-specific death associated with micrometastases for each ethnic group. Results: The 8-year breast cancer-specific survival was 96.6 % for women with node-negative breast cancers and was 94.6 % for women with micrometastases (adjusted HR 1.49; 95 % CI 1.31–1.69; P < .001). Among women with micrometastases, the 8-year breast cancer-specific survival was 95.1 % for white women and was 90.6 % for black women (HR 1.80; 95 % CI 1.29–2.52; P = .0006). Conclusion(s): Nodal micrometastasis is an independent risk factor for breast cancer mortality among women with early-stage breast cancer. Black women are more likely to die from breast cancer with micrometastases than white women. © 2016 Springer Science+Business Media New York


PubMed | Womens College Research Institute Womens College Hospital
Type: | Journal: Breast cancer research and treatment | Year: 2016

The clinical significance of nodal micrometastasis is debated. Our primary objective was to determine whether, among women with early-stage breast cancer, regional lymph node micrometastasis is an independent risk factor for mortality. The secondary objective was to identify subgroups of women who have the highest risk of death from early-stage breast cancer with micrometastases.206,625 women diagnosed with early-stage breast cancer (IA, IB, and IIA) from 2004 to 2012 were identified in the Surveillance, epidemiology, and end results database. Nodal status was classified as node-negative, isolated-tumor cells, micrometastases, and macrometastases. Women were classified into eight ethnic groups. Logistic regression was performed to estimate the odds ratio of being diagnosed with micrometastases. The Cox proportional hazard model was used to estimate the hazard ratio (HR) of breast cancer-specific death associated with micrometastases for each ethnic group.The 8-year breast cancer-specific survival was 96.6% for women with node-negative breast cancers and was 94.6% for women with micrometastases (adjusted HR 1.49; 95% CI 1.31-1.69; P<.001). Among women with micrometastases, the 8-year breast cancer-specific survival was 95.1% for white women and was 90.6% for black women (HR 1.80; 95% CI 1.29-2.52; P=.0006).Nodal micrometastasis is an independent risk factor for breast cancer mortality among women with early-stage breast cancer. Black women are more likely to die from breast cancer with micrometastases than white women.

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