Articles: checklist.
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Early phase dose-finding (EPDF) trials are crucial for the development of a new intervention and influence whether it should be investigated in further trials. Guidance exists for clinical trial protocols and completed trial reports in the SPIRIT and CONSORT guidelines, respectively. However, both guidelines and their extensions do not adequately address the characteristics of EPDF trials. Building on the SPIRIT and CONSORT checklists, the DEFINE study aims to develop international consensus-driven guidelines for EPDF trial protocols (SPIRIT-DEFINE) and reports (CONSORT-DEFINE). ⋯ By detailing the development journey of the DEFINE study and the decisions undertaken, we envision that this will enhance understanding and help researchers in the development of future guidelines. The SPIRIT-DEFINE and CONSORT-DEFINE guidelines will allow investigators to effectively address essential items that should be present in EPDF trial protocols and reports, thereby promoting transparency, comprehensiveness, and reproducibility.
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The World Health Organization Safe Childbirth Checklist (SCC) has been recommended globally. However, the results are inconsistent. The aim of this study was to investigate the effectiveness of implementing the SCC based on plan-do-check-act (PDCA) cycle management. ⋯ After the intervention, postpartum hemorrhage, neonatal mortality, and neonatal asphyxia rates were also reduced, although no significant differences were observed between the 2 groups. There was no significant difference in the third-degree perineal laceration or neonatal intensive care unit hospitalization rate between the 2 groups (P > .05). Application of the PDCA cycle can improve the SCC utilization rate, and the SCC combined with the PDCA cycle can effectively reduce the postpartum infection rate.
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An Operation Note should provide a comprehensive account of the details of a surgical procedure performed and document clinically relevant events which occur throughout the procedure. The Royal College of Surgeons of England, in 2014, updated guidelines on specific criteria to be included in operation notes. Standardisation using procedure-specific operation notes has been shown to significantly improve adherence to these guidelines. The aim of this study was to evaluate the quality of operation notes in the Irish National Burns Unit before and after the design and implementation of an electronic patient record and the subsequent introduction of an operation template and a burns surgery specific checklist, within the electronic system. ⋯ The use of an electronic patient record to document a patient's procedure has been shown to significantly improve the quality of documentation. One could expect this to result in an improved patient hand-over and subsequent episode of care. We highlight a number of initial pit-falls that others may avoid in their implementation of a digital record.