It is easy for armchair activists to bash randomized controlled trials (RCTs) with clever methodological critiques. However, it takes a lot of effort and coordination to pull off an RCT successfully. In this episode of Radiology Firing Line, I speak with Dr. Mark Neuman and Lakisha Gaskins, principal investigator and research project manager of the REGAIN trial, respectively, about the logic, challenges and intricacies of conducting an RCT. The Regional versus General Anesthesia for Promoting Independence After Hip Surgery (REGAIN) trial is an ongoing pragmatic, multi-center RCT, funded by PCORI, which randomizes patients with hip fractures to regional or general anesthesia.
Guests: Mark Neuman MD MSc, is an Associate Professor of Anesthesiology and Critical Care at the University of Pennsylvania. He is a senior fellow at the Leonard Davis Institute of Health Economics. He’s a former RWJ Scholar. Lakisha Gaskins is a research coordinator with extensive experience recruiting patients for RCTs.
Listen to our conversation on Radiology Firing Line Podcast here.
Saurabh Jha is a contributing editor to THCB and host of Radiology Firing Line Podcast of the Journal of American College of Radiology, sponsored by Healthcare Administrative Partner.
September was an important month in oncology—especially for lung cancer. The World Conference in Lung Cancer (WCLC) 2018 gave us some important practice-changing results, also leading to four NEJM publications. The trial with most public health impact is unfortunately not published yet. It’s the NELSON trial that randomised more than 15000 asymptomatic people at high risk of lung cancer to either CT-based screening for lung cancer or to no screening and found a significant reduction in lung cancer mortality rates among the screened cohort compared with the control cohort. This reduction was more pronounced among women, although they constituted only 16% of the trial population. I am looking forward to reading the full publication and am particularly interested in knowing if there were any differences in all-cause mortality rates and the rates of overdiagnoses.
A new ALK-inhibitor on the block—brigatinib—has significantly improved PFS versus crizotinib when used as first-line therapy in ALK-positive non-small cell lung cancer (NSCLC) patients. However, I assume that it will be difficult for brigatinib to replace alectinib in this setting, since the latter has already been tested in two different RCTs and has more mature data.
With Keynote 407, pembrolizumab has entered into the treatment arsenal for squamous NSCLC by improving overall survival in combination with chemotherapy versus chemotherapy alone as a first-line regimen. However, when A B is compared with A, it is important to know whether A B is better than A followed by B. In this trial, 32% of patients who were in the control arm received a PD-1 inhibitor upon progression. Nivolumab is already approved as a second-line option in this setting after first-line chemo; so how much benefit in Keynote 407 is due to more than half of control arm patients not getting PD-1 inhibitor at all versus the benefit of combining pembrolizumab with chemo upfront is an important question.
This month, we saw historic turnout at the polls for midterm elections with over 114 million ballots cast. One noteworthy observation regarding voter turnout is record rates of participation by younger voters aged between 18 to 29 years old. Around 31 percent of people aged 18 to 29 voted in the midterms this year, an increase from 21 percent in 2014, according to a day-after exit poll by Tufts University.
Surely their political engagement counters the criticism that millennials are disengaged and disconnected with society and demonstrates that millennials are fully engaged when issues are relevant to them, their friends, and their families. Why, then, do we not see the same level of passion, engagement and commitment when young adults are asked to consider their health and well-being?
I have had the privilege of being a member of the National Heart, Lung and Blood Institute-funded Coronary Artery Risk Development in Young Adults (CARDIA) study research team. In over 5,000 black and white adults who were initially enrolled when they were 18 to 30 years old and have now been followed for nearly 35 years, we have described the decades-long process by which heart disease develops. We were able to do this because, in the 1980s when these studies began, young adults could be reached at their home telephone numbers. When a university researcher called claiming to be funded by the government, there was a greater degree of trust.
Unfortunately, that openness and that trust has eroded, particularly in younger adults and those who may feel marginalized from our society for any number of valid reasons. However, the results—unanswered phone calls from researchers, no-shows at the research clinic and the absence of an entire group of adults today from research studies, looks like disengagement. Disengagement is a very real public health crisis with consequences that are as dire as any political crisis. Continue reading…