Coordination of international multicenter studies: governance and administrative structure

Bangdiwala, Shrikant I.; Paula, Cristiane Silvestre de; Ramiro, Laurie S.; Muñoz, Sergio

doi:10.1590/s0036-36342003000100008

Cited by 22 publications

(12 citation statements)

References 3 publications

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“…It is part of a multicenter project called World Studies of Abuse in Family Environments (WorldSAFE), which is an international initiative involving researchers from Brazil, Chile, Egypt, Philippines, India, and United States. 3 The present study was conducted in 1999 in the Jardim Santa Emília neighborhood, a lowincome area of the municipality of Embu, Southeastern Brazil. There were no slums in this neighborhood.…”

Section: Methodsmentioning

confidence: 99%

Prevalência e procura de ajuda na violência conjugal física ao longo da vida

2006

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OBJECTIVE:To estimate the lifetime prevalence of physical marital violence among women from a low-income urban community and to investigate help-seeking behavior among victims. METHODS:This is the Brazilian pilot cross-sectional study for an international multicenter study conducted in 1999, and is based on a probabilistic cluster sample from the municipality of Embu, São Paulo State. We considered as eligible women aged 15 to 49 years, living with children under age 18 years, who had lived with a husband or partner in lifetime. Information was collected using standardized questionnaires (n=86), administered by trained interviewers. We investigated three types of physical violence: severe (kicking, hitting with fist, beating, and/or use/ threat to use weapon), non-severe (slapping in the absence of severe violence), and any type (severe and/or non-severe and/or other physical aggressions spontaneously referred), as well as the type of help sought by the victim (from people or institutions). We calculated frequency and 95% confidence intervals for each type of violence. RESULTS:Subjects reported slapping (32.6%), hitting with fist (17.5%), beating (15.2%), use/threat to use weapon (13.9%), and kicking (10.6%). Prevalence of marital violence was high: 22.1% (13.3-30.9) for severe violence, 10.5% (4.0-17.0) for non-severe violence, and 33.7% (32.7-34.7) for any type of violence. Victims of severe violence were more likely to seek help from the police (36.8%) or from traditional healers (21.1%) than from health care facilities (5.3%), despite the availability of these services in the area. CONCLUSIONS:Physical marital violence is frequent and severe among the population studied, and help was sought preferentially from the police or traditional healers rather than from health care services.

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Section: Methodsmentioning

confidence: 99%

Prevalência e procura de ajuda na violência conjugal física ao longo da vida

2006

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“…The DCC was responsible for providing the comprehensive supportive research infrastructure for developing, maintaining, and administering contractual agreements with each clinical site; 11;12 standardized data collection processes and management across the Consortium including the training of clinical site personnel in project management and data entry, quality and security; 13;14 and site monitoring and statistical analysis. 11;15 The main objectives of this article are: 1) to describe in detail the design and development of PROMMTT; and 2) to discuss key methodological challenges associated with conducting a multicenter study of massive transfusion and lessons learned related to the coordination, and management of PROMMTT.…”

Section: Introductionmentioning

confidence: 99%

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

et al. 2012

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Aim Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the U.S. Methods PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1,245 patients who received one or more blood transfusions within 6 hours of ED admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials.

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“…The main purpose is to increase efficiency and uniformity across the sites. [9;17] The key focus of study management is on the implementation of the study protocol [9] and ensuring data quality and patient safety. [18] Key personnel in the exemplar multisite study included the investigators, project manager, study statistician, education coordinator, site recruiters, interveners (reflexologist and placebo providers), interviewers, chart auditors, database programmers, information technology specialist, and student staff.…”

Section: Methods and Resultsmentioning

confidence: 99%

“…[7;8] Third, since all sites follow a common standardized protocol and adequate quality assurance measures are in place to ensure adherence to the study protocol, the resulting data have a higher level of integrity and quality. [5;9] Finally, multisite studies usually benefit from a larger pool of diverse expertise needed for a successful completion of complex trials. These characteristics are equally applicable to complementary and alternative medicine (CAM) multisite RCTs.…”

Section: Introductionmentioning

confidence: 99%

Coordination and management of multisite complementary and alternative medicine (CAM) therapies: Experience from a multisite reflexology intervention trial

Rahbar¹,

Wyatt²,

Sikorskii³

et al. 2011

Contemporary Clinical Trials

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Background Multisite randomized clinical trials allow for increased research collaboration among investigators and expedite data collection efforts. As a result, government funding agencies typically look favorably upon this approach. As the field of complementary and alternative medicine (CAM) continues to evolve, so do increased calls for the use of more rigorous study design and trial methodologies, which can present challenges for investigators. Purpose To describe the processes involved in the coordination and management of a multisite randomized clinical trial of a CAM intervention. Methods Key aspects related to the coordination and management of a multisite CAM randomized clinical trial are presented, including organizational and site selection considerations, recruitment concerns and issues related to data collection and randomization to treatment groups. Management and monitoring of data, as well as quality assurance procedures are described. Finally, a real world perspective is shared from a recently conducted multisite randomized clinical trial of reflexology for women diagnosed with advanced breast cancer. Results The use of multiple sites in the conduct of CAM-based randomized clinical trials can provide an efficient, collaborative and robust approach to study coordination and data collection that maximizes efficiency and ensures the quality of results. Conclusions Multisite randomized clinical trial designs can offer the field of CAM research a more standardized and efficient approach to examine the effectiveness of novel therapies and treatments. Special attention must be given to intervention fidelity, consistent data collection and ensuring data quality. Assessment and reporting of quantitative indicators of data quality should be required.

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Coordination of international multicenter studies: governance and administrative structure

Abstract: El texto completo en inglés de este artículo también está disponible en: http://www.insp.mx/salud/index.html

Cited by 22 publications

References 3 publications

Prevalência e procura de ajuda na violência conjugal física ao longo da vida

Prevalência e procura de ajuda na violência conjugal física ao longo da vida

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

Coordination and management of multisite complementary and alternative medicine (CAM) therapies: Experience from a multisite reflexology intervention trial

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