1. Brophy Marcus, Mary

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For doctors and patients weighing the pros and cons of invasive diagnostic procedures, the results of a new real-world study now add more context to their decision-making process when it comes to lung cancer screening.

diagnostic tests; lu... - Click to enlarge in new windowdiagnostic tests; lung cancer. diagnostic tests; lung cancer

The research looked at the complication rates and downstream medical costs linked with invasive diagnostic lung procedures in a community setting (JAMA Intern Med 2019; doi:10.1001/jamainternmed.2018.6277). The results: complication rates were twice as high compared to findings from a major clinical trial published in 2011-the National Lung Screening Trial (NLST).


Lung Research Findings

For the new study, scientists from the University of Texas MD Anderson Cancer Center, Houston, combed through a national database of claims data and analyzed records of 344,510 people between the ages of 55 and 77, identifying about half who'd had invasive diagnostic lung procedures (needle biopsy, bronchoscopy, and thoracic surgery) between 2008 and 2013. They compared those patients to a control group of more than 169,800 people who hadn't undergone any of these invasive procedures.


Breaking down the data by age group, they found that the post-procedural complication rate was 22.2 percent in patients ages 55-64, and almost 23.8 percent in older patients ages 65-77 years. The rates were approximately two times as high as those reported in the NLST, which were 9.8 percent and 8.5 percent, respectively.


The researchers also tallied the downstream medical costs associated with complications, reporting that figures ranged from $6,320 for minor complications and climbed as high as $56,845 for major issues.


"This study will help physicians to talk about the harm-benefit trade-off of invasive diagnostic procedures with patients," said study author Ya-Chen Tina Shih, PhD, Professor of Health Economics in the Department of Health Services Research at The University of Texas MD Anderson Cancer Center.


Shih noted that in 2015-after the NLST study showed a 16 percent reduction in lung cancer mortality associated with low-dose computed tomography (LDCT)-the Centers for Medicare & Medicaid Services (CMS) added lung cancer screening with LDCT as a Medicare preventive service benefit. But LDCT is linked with a high false-positive rate that leads to more invasive diagnostic procedures. She and colleagues were motivated to perform their study to figure out just how risky those procedures were in a community setting.


Anil Vachani, MD, Co-Director of The Lung Cancer Screening Program at Penn Medicine and Associate Professor of Medicine at The Hospital of the University of Pennsylvania and The Veteran's Administration Medical Center, Philadelphia, said the new research is intriguing.


"The idea is to try and understand if the results of the national screening trial are going to be representative of what we see in clinical practice as screening takes hold and is implemented widely across the U.S. population. I commend the authors for attempting to look at this question," he said.


Vachani noted though that the study wasn't performed in the current era of lung cancer screening so it doesn't necessarily capture the same types of patients undergoing invasive diagnostic testing at this point in time.


"The population in the study is not an LDCT-screened population, so I'd look at the rates of complications [in the new study] with some caution as we try to relate it to a screened population now," he said.


Vachani also pointed out that diagnostic tools and techniques have improved over the last 5-10 years.


"It's fair to say that over the last decade we're seeing the evolution of pulmonologists and thoracic surgeons using more minimally invasive approaches and more robotic techniques. There are more advances when it comes to being able to navigate lesions. Minimizing complications still rests on good communication and decision-making, but better technology has also resulted in lower complication rates as more thoracic surgeons and pulmonologists are trained in these technologies," Vachani said.


Denise Aberle, MD, Professor of Radiology and Vice Chair of Research at UCLA's Jonsson Comprehensive Cancer Center, pointed out that where a patient gets screened plays a critical role as well. She noted that the literature has shown differences in the surgical outcomes of patients based on whether or not a trained thoracic oncologic surgeon is performing a procedure.


"What may be evident from this study is the attention that should be paid to local screening centers, and the fact that expertise and subspecialty training in imaging, pulmonary medicine, and thoracic surgery are a critical determinant of patient outcomes-none of which was reported in this study," Aberle said.


Where and who patients get care from influences not just surgical complication rates and outcomes, but also tests and informed decision-making that should be performed pre-operatively to determine the fitness of a patient for a surgical procedure, she said.


"Centers lacking expertise would ideally refer patients to the appropriate centers," Aberle added.


Patients should be encouraged to educate themselves, too, said Len Horovitz, MD, a pulmonologist with Lenox Hill Hospital in New York City.


"I think patients need to be aware that they need to ask about complications and they need to be told the numbers. People often just want to know, 'What's the chance I'll be cured. Will I ever feel like myself again?' But they have to understand that a post-procedural complication isn't a 1-day affair. It could mean weeks of treatment. They need to think about the quality of life and what their risks are," said Horovitz.


UCLA's Abperle said at UCLA shared decision-making follows the basic tenets stated in the CMS decision and includes covering the following topic areas with patients:


* eligibility criteria;


* risks (frequencies and risks of false positives, potential downstream diagnostic testing, over-diagnosis, and radiation exposure) ;


* the benefits of screening and early lung cancer detection (specifically within the context of their known comorbidities);


* the implications of a positive screen;


* the importance of annual screening;


* a patient's willingness to undergo diagnosis and treatment;


* and smoking cessation counseling and treatment.



Mary Brophy Marcus is a contributing writer.


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