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(data safety monitoring board)
1,047 results
  • Data monitoring committees: Promoting best practices to address emerging challenges. [Journal Article]
  • CTClin Trials 2017; 14(2):115-123
  • Fleming TR, DeMets DL, … Ellenberg SS
  • CONCLUSIONS: Prospective data monitoring committee members need better training. Options could include didactic instruction as well as apprenticeships to provide real-world experience. Data monitoring committee members should be protected against legal liability arising from their service. While avoiding breaches in confidentiality of interim data remains a high priority, data monitoring committees should have access to unblinded efficacy and safety data throughout the trial to enable informed judgments about risks and benefits. Because overly rigid procedures can compromise their independence, data monitoring committees should have the flexibility necessary to best fulfill their responsibilities. Data monitoring committee charters should articulate principles that guide the data monitoring committee process rather than list a rigid set of requirements. Data monitoring committees should develop their recommendations by consensus rather than through voting processes. The format for the meetings of the data monitoring committee should maintain the committee's independence and clearly establish the leadership of the data monitoring committee chair. The independent statistical group at the Statistical Data Analysis Center should have sufficient depth of knowledge about the study at hand and experience with trials in general to ensure that the data monitoring committee has access to timely, reliable, and readily interpretable insights about emerging evidence in the clinical trial. Contracts engaging data monitoring committee members for industry-sponsored trials should have language customized to the unique responsibilities of data monitoring committee members rather than use language appropriate to consultants for product development. Regulatory scientists would benefit from experiencing data monitoring committee service that does not conflict with their regulatory responsibilities.
  • Improving Surgical Complications and Patient Safety at the Nation's Largest Military Hospital: An Analysis of National Surgical Quality Improvement Program Data. [Journal Article]
  • MMMil Med 2017; 182(3):e1752-e1755
  • Maturo S, Hughes C, … Brennan J
  • CONCLUSIONS: NSQIP data at the Department of Defense's largest hospital reveals complication rates similar to civilian hospitals. The majority of areas studied revealed improving or stable complication rates. The ACS NSQIP is a nationally validated, risk-adjusted, outcomes program that is widely used by many leading hospital institutions. Similar to most quality data reporting articles, a weakness of our study may have been collection of all complications. Yet, we are confident that the majority of complications were captured as we have dedicated personnel monitoring the adverse events measured by ACS NSQIP. Future areas of study should focus on continued analysis of surgical quality improvement within the entire military system.
  • Sharing interim trial results by the Data Safety Monitoring Board with those responsible for the trial's conduct and progress: a narrative review. [Review]
  • TTrials 2017 Mar 09; 18(1):120
  • Borg Debono V, Mbuagbaw L, Thabane L
  • CONCLUSIONS: There was no majority view in the literature. However, the largest group of citations included express the idea that interim results should remain confidential with the DSMB but also acknowledge circumstances when they could be shared with non-DSMB members. Limitations of this review are that (1) the included literature predominately provides personal perspectives, not evidence, and (2) surveys found globally focus on trial monitoring practices lacking detailed information on what specifically to share, with whom and why. More research is needed with the use of a detailed survey of the clinical trial community focused on DSMB sharing interim results, to better understand and guide DSMB interim result sharing practices.
  • Measuring harm and informing quality improvement in the Welsh NHS: the longitudinal Welsh national adverse events study [BOOK]
  • BOOKNIHR Journals Library: Southampton (UK)
  • Mayor S, Baines E, … Gray J
  • CONCLUSIONS: The extent of harm detected across NHS Wales using both the two-stage retrospective review process and the new Harm2 tool conforms to the findings in the literature, but this is the first longitudinal study using these methods. With training and using a structured review process, non-physician reviewers can undertake case note review efficiently and effectively, and the rates of AEs and of the preventability and the breakdown of problems in care conform to those reported in studies in which physicians undertake these classifications. Whether the patient died or was discharged alive significantly influences the rate and composition of AEs. The Harm2 tool performed with moderate reliability in the determination of AEs.
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