Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Int J Radiat Oncol Biol Phys. 2024 May 1;119(1):11-16. doi: 10.1016/j.ijrobp.2023.09.025. Epub 2023 Sep 27.
Clinical trial participation continues to be low, slowing new cancer therapy development. Few strategies have been prospectively tested to address barriers to enrollment. We investigated the effectiveness of a physician audit and feedback report to improve clinical trial enrollment.
We conducted a randomized quality improvement study among radiation oncologists at a multisite tertiary cancer network. Physicians in the intervention group received quarterly audit and feedback reports comparing the physician's trial enrollments with those of their peers. The primary outcome was trial enrollments.
Among physicians randomized to receive the feedback report (n = 30), the median proportion of patients enrolled during the study period increased to 6.1% (IQR, 2.6%-9.3%) from 3.2% (IQR, 1.1%-10%) at baseline. Among those not receiving the feedback report (n = 29), the median proportion of patients enrolled increased to 4.1% (IQR, 1.3%-7.6%) from 1.6% (IQR, 0%-4.1%) at baseline. There was a nonsignificant change in the proportion of enrollments associated with receiving the feedback report (-0.6%; 95% CI, -3.0% to 1.8%; P = .6). Notably, there was an interaction between baseline trial accrual and receipt of feedback reports (P = .005), with enrollment declining among high accruers. There was an increase in enrollment throughout the study, regardless of study group (P = .001).
In this study, a positive effect of physician audit and feedback on clinical trial enrollment was not observed. Future efforts should avoid disincentivizing high accruers and might consider pairing feedback with other patient- or physician-level strategies. The increase in trial enrollment in both groups over time highlights the importance of including a comparison group in quality improvement studies to reduce confounding from secular trends.
临床试验参与率仍然很低，这减缓了新癌症疗法的开发。很少有策略被前瞻性地测试来解决入组障碍。我们研究了医生审核和反馈报告的有效性，以改善临床试验入组。
我们在一个多地点的三级癌症网络中的放射肿瘤学家中进行了一项随机质量改进研究。干预组的医生每季度收到一次审核和反馈报告，比较医生的试验入组人数与同行的入组人数。主要结果是试验入组。
在随机接受反馈报告的医生中（n = 30），研究期间入组患者的中位数比例从基线时的 3.2%（IQR，1.1%-10%）增加到 6.1%（IQR，2.6%-9.3%）。在未接受反馈报告的医生中（n = 29），入组患者的中位数比例从基线时的 1.6%（IQR，0%-4.1%）增加到 4.1%（IQR，1.3%-7.6%）。与接受反馈报告相关的入组比例没有显著变化（-0.6%；95%CI，-3.0%至 1.8%；P =.6）。值得注意的是，基线试验入组人数和反馈报告的接收之间存在交互作用（P =.005），高入组者的入组率下降。无论研究组如何，整个研究期间入组人数都有所增加（P =.001）。
在这项研究中，医生审核和反馈对临床试验入组没有产生积极影响。未来的努力应避免对高入组者产生不利影响，并且可能考虑将反馈与其他患者或医生层面的策略相结合。两组中试验入组率随时间的增加突出了在质量改进研究中纳入对照组的重要性，以减少来自时间趋势的混杂。
