Third Of Phase Research Articles

Core training and surgical opportunities: a UK-based analysis

The COVID-19 pandemic, the new Intercollegiate Surgical Curriculum Programme curriculum and the European Work Time Directive significantly reduced surgical exposure for trainees. This study analyzed the operative experience of Phase 1 trainees (CT1/ST1 vs. CT2/ST2) against the Annual Review of Competence Progression (ARCP) criterion of 120 procedures yearly. National survey research in October 2021. Study end-point was the completion of >4 weekly procedures, equivalent to 120 cases per year. Chi-square test and multivariate regression analysis were performed. 205 participants from 5 Deaneries were included, 48.3% were CT1/ST1 and 51.7% were CT2/ST2. About 54.5% of year-1 and 50% of year-2 trainees were 28 30 years old, 55.6% and 50.9% were male, and 39.4% and 38.7% were White British. About 39.4% of CT1/ST1 and 22.6% of CT2/ST2 performed <4 weekly procedures (P = 0.01), with no difference in the "Observed" (P = 0.6) or "Assisted" (P = 0.3) number of cases. CT2/ST2 recorded more "ST-S" (p 0.04), "S-TU" (P = 0.03), and "Performed" (P = 0.02) operations. For CT1/ST1, older age (HR 2.4, 95% CI [1.1; 5.3], P = 0.02) and southern deaneries (HR 1.7, 95% CI [1.2; 2.4], P = 0.004) were independent factor for <4 weekly procedures. For CT2/ST2, northern regions were associated with more favorable training (HR 1.4, 95% CI [1.1; 1.7], P = 0.01). Over one third of Phase 1 trainees do not meet the ARCP requirement of >120 procedures annually. Age and region of training are independent factors in the number of logbook cases. This research focuses on training opportunities for junior surgical residents across the United Kingdom. The degree and type of exposure to the operating theatre have a significant impact on the development of surgical competencies. These are undoubtedly related to patient outcomes, as the quality of care delivered to patients and relatives greatly relies on the training background of future consultant surgeons.

When Hope Hinders Science and Patient-Centered Care

When Hope Hinders Science and Patient-Centered Care

Achieving sufficient accrual to address the primary endpoint in phase III clinical trials from U.S. Cooperative Oncology Groups.

Assessing impact of poor accrual on premature trial closure requires a relevant metric. We propose defining accrual sufficiency on apparent ability to address primary endpoints (PE) rather than attaining accrual targets. All phase III trials open January 1, 1993, to December 31, 2002, by five U.S. oncology Clinical Trials Cooperative Groups (CTCG) were evaluated for accrual sufficiency and scientific results. Sufficient accrual included meeting accrual target, CTCGs documentation attesting adequate accrual, or conclusive results at interim analysis; insufficient accrual included poor accrual as cited closure reason or other reasons rendering a trial unable to address its primary endpoints. Closure rates based on our accrual sufficiency definition are compared with rates of meeting accrual targets and addressing the primary endpoints. A percentage of target accrual above which trials commonly answer the intended scientific question was identified to serve as an alternative to meeting full target accrual in designating accrual success. Of 238 eligible trials, 158 (66%) closed with sufficient accrual. Among 80 trials with insufficient accrual, 70 (29%) closed specifically because of poor accrual. Inadequate accrual rates are overemphasized when defining accrual success solely by meeting accrual targets. Nearly 75% of trials conclusively addressed the primary endpoints with positive results in 39% of trials. Exceeding 80% of target accrual serves as a reliable proxy for answering the intended scientific question. Approximately one third of phase III trials closed with insufficient accrual to address the primary endpoints, primarily due to poor accrual. Defining accrual sufficiency broader than meeting accrual targets represents a fairer account of trial closures.