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Complication rates after invasive diagnostic lung procedures twice as high in community setting
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Complications after invasive diagnostic procedures for lung abnormalities occurred twice as often in the real-world setting than in clinical trials that served as the basis for adoption of lung cancer screening with low-dose CT, according to results of a retrospective cohort study.
These complications also resulted in high downstream costs.
“The rates of complications estimated in our study reflected rates that are likely to be found in the community with the implementation of low-dose CT screening at [the] population level,” Ya-Chen Tina Shih, PhD, chief of the section of cancer economics and policy and professor in the department of health services research at The University of Texas MD Anderson Cancer Center, told HemOnc Today. “Therefore, our study provided more relevant estimates for the risks-benefits discussions during the shared decision-making communications.”
In 2015, CMS began covering annual low-dose CT lung cancer screening for Medicare beneficiaries aged 55 to 77 years who have a 30 pack-year smoking history and either currently smoke or have quit within the past 15 years.
CMS based its coverage decision on results of the National Lung Screening Trial, which showed screening with low-dose CT reduced lung cancer mortality by 16% among high-risk individuals.
However, low-dose CT screening is associated with a high false-positive rate. Thoracic imaging often yields abnormal findings that require individuals to undergo invasive diagnostic procedures, raising the risk for complications.
“Clinical trial protocols often set out rules for participating sites to follow, and many of those rules serve the purpose of quality control,” Shih said. “Therefore, it is possible that complication rates observed in the real-world practice in a less controlled environment will be higher than those reported in trials.”
Shih and colleagues conducted a retrospective cohort study to calculate the complication rate and downstream medical costs associated with invasive diagnostic procedures to investigate lung abnormalities among patients treated in the community setting.
Investigators used the Medicare database and MarketScan Commercial Claims & Encounters database to identify a nationally representative sample of patients aged 55 to 77 years.
The analysis included 174,702 individuals (62.6% women) who underwent invasive diagnostic procedures between 2008 and 2013 at nonprotocol-driven community practices. These procedures included cytology test or biopsy (26.1%), bronchoscopy (25.6%), thoracic surgery (5.4%) or other types (42.9%). All procedures included in the analysis matched those documented in the National Lung Screening Trial.
The study by Shih and colleagues also included a control group of 169,808 individuals (62.4% women) who did not undergo invasive diagnostic procedures.
Researchers divided patients into two age groups (55 to 64 years vs. 65 to 77 years). They then adjusted for differences in complication rates between the study and control cohorts for each age group.
Results showed complications after invasive diagnostic procedures occurred more than twice as often in the community setting than the National Lung Screening Trial. This trend persisted among both younger patients (22.2% vs. 9.8%) and older patients (23.8% vs. 8.5%).
The magnitude of difference can be explained by differences in demographics and case mix between real-world patients and trial participants, as well as the difference between real-world practices and sites that participated in trials, Shih told HemOnc Today.
Investigators also analyzed downstream costs associated with postprocedural complications. They calculated mean incremental complication costs of $6,320 (95% CI, 5,863-6,777) for minor complications and $56,845 (95% CI, 47,953-65,737) for major complications.
The costs for major complications did not surprise investigators, Shih said.
“Many of these complications would require hospitalizations, and the inpatient costs in the U.S. were high,” she said. “Initially, we were a bit surprised by the costs of minor complications. [However, after] considering that our study was based on claims data and, therefore, would only capture minor complications that were severe enough for patients to seek care from doctors, the estimates seemed reasonable.”
Researchers acknowledged the study was limited by its retrospective nature and the fact that data did not show which individuals underwent invasive procedures subsequent to low-dose CT screening. Investigators intend to perform more direct analyses in that group when such data become available.
Still, these results offer valuable insights about the potential risks for complications after invasive diagnostic procedures, as well as their high downstream costs, Shih and colleagues concluded.
“It’s very important for physicians to include information about possible adverse risks when communicating with their patients considering lung cancer screening,” Shih said in a press release. “Our findings suggest these complications may be higher than anticipated when implementing lung cancer screening programs outside a clinical trial setting, and the health care system needs to be ready for that potential issue.” – by Mark Leiser
For more information:
Ya-Chen Tina Shih, PhD, can be reached at Department of Health Services Research, Unit 1444, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030; email: yashih@mdanderson.org.
Disclosures : The authors report no relevant financial disclosures.
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Huo J, et al. JAMA Intern Med. 2019;doi:10.1001/jamainternmed.2018.6277.
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