CME Author: Zeena Nackerdien
Study Authors: Jinhai Huo, Ying Xu, et al. and James S. Goodwin, Shawn Nishi, et al.
Target Audience and Goal Statement:
Oncologists, pulmonologists, and primary Care Physicians
The goal was to understand the outcomes and uptake of shared decision-making (SDM) and screening for lung cancer with low-dose CT (LDCT) in high-risk patients.
The questions addressed by the two studies reviewed were:
- What are the complication rates and downstream medical costs associated with invasive diagnostic procedures for lung abnormalities in the community setting?
- How many select Medicare beneficiaries participated in separate, SDM visits, mandated by the Centers for Medicare & Medicaid Services (CMS), before LDCT and with receipt of LDCT after SDM?
- Could outcomes from the two studies inform policy decisions about where best to utilize lung cancer screening (LCS) resources?
Synopsis and Perspective:
Lung cancer is the top cause of cancer-related deaths in the U.S., and the 5-year survival for advanced disease is still only 16% (versus a relative 5-year survival of 56.3% for patients with localized disease). Most patients (70%) present with advanced disease, making screening for the disease in its early or asymptomatic stages a nationwide priority.
LDCT emerged as a viable, non-invasive lung cancer screening option as “LDCT of the chest uses lower amounts of radiation than the standard chest CT and does not require the use of intravenous (IV) contrast dye,” according to the American Cancer Society.
Results from the 2011 National Lung Screening Trial (NLST), which randomly assigned more than 53,000 smokers or former smokers to three annual screens with chest x-ray or spiral LDCT, showed a 20% reduction in lung cancer-related mortality versus chest x-ray screening. After this landmark trial, healthcare funders in the U.S. and Canada adopted lung cancer screening recommendations. Definitive recommendations by the U.S. Preventive Services Task Force (USPSTF) extended the age range adopted by the NLST to include screening for patients ages 55 to 80 with at least a 30-pack-year smoking history who are current smokers or have quit within the previous 15 years.
But screening experts were concerned about the 23.3% false-positive rates reported for LDCT. They were concerned that the 8.5%-9.8% complication rate in the wake of a false-positive LDCT LCS diagnosis reported by NLST could be translated into substantial harms and financial burdens when scaled up to the entire U.S. population.
There was a need to determine whether rates of complications among the screening-eligible general population would mirror rates observed for the healthier NLST participants. An additional need was to understand if conversations about LCS would impact patient choices about whether to undergo the procedure.
Retrospective study of community practices
Using the 2008-2013 Truven MarketScan databases, Ya-Chen Tina Shih, PhD, of the MD Anderson Cancer Center in Houston, and colleagues searched for claims representing similar procedures for lung abnormalities as those reported in the NLST. This was an indirect strategy, as the relevant billing code for LDCT LCS was only established in 2015.
Among the eligible participants (ages 55-70), 174,702 comprised the study group (62.6% women) and 169,808 (62.4% women) served as controls.
The main outcomes were 1-year complication rates calculated for four invasive diagnostic procedures: cytology/needle biopsy, bronchoscopy, thoracic surgery, and other procedures. Complication rates and costs were further stratified according to age.
Complication rates were high in the current study cohort (18.7% after needle biopsy, 36.1% after bronchoscopy, and 51.7% after thoracic surgery). Overall, rates of post-procedural complications were more than twice the rates in the NLST among younger (ages 55-64; 22.2% vs 9.8%) and older (ages 65-77; 23.8% vs 8.5%) individuals. Mean incremental complication costs ranged from $6,320 (95%CI $5,863-$6,777) for minor complications to $56,845 (95%CI $47,953-$65,737) for major complications.
Study limitations included the inability to determine the extent to which the higher complication rates observed in the community settings were owing to lower quality of care in these facilities, less experienced physicians performing these procedures, or unmeasured patient-level factors, the authors noted. Importantly, there was a lack of direct data on people meeting LCS eligibility criteria who received LCS, given that the study period predated CMS reimbursement for LCS.
Using Medicare data from 2015 and 2016, James Goodwin, MD, of the University of Texas Medical Branch at Galveston, and colleagues determined the percentage of enrollees (ages 55-77) who had an LDCT LCS and a visit for SDM. Parts A and B Medicare recipients were divided into 2015 (4,192,802 persons) and 2016 (4,138,559 persons) cohorts.
The investigators estimated the odds of patients with LDCT having undergone SDM prior to the procedure versus the relative risk of undergoing LDCT after informed conversations. Age, sex, race/ethnicity, Medicaid eligibility, region, comorbidities, and education (at the zip code level) were also analyzed in this study.
The authors reported that 1,719 of 19,021 enrollees in 2106 had a separate SDM visit on the day of LDCT LCS or in the previous 3 months. Being black versus white (odds 0.76; 95% CI 0.59-0.97) or female (OR 0.88., 95% CI 0.79-0.98), or having a higher education (OR 0.81, 95% CI 0.68-0.96) was independently associated with lower odds of SDM before LDCT LCS. The investigators also noted wide regional variations.
Almost two-thirds (60.8%) of the 2,154 enrollees who participated in SDM underwent LDCT LCS in the next 3 months.
Study limitations included the fact that results from participants (ages 65-77) with fee for service Parts A and B Medicare may not be generalizable to those in Medicare health maintenance organizations (HMOs), the investigators noted.
Source References: JAMA Internal Medicine, Jan. 14, 2019; DOI:10.1001/jamainternmed.2018.6277
JAMA Internal Medicine, Jan. 14, 2019; DOI:10.1001/jamainternmed.2018.6405
Study Highlights: Explanation of Findings
Retrospective study of community practices
Based on a cohort study of 344,510 patients in national databases, estimated complication rates of 22.% (those ages 55-64) and 23.8% (those ages 65-77) exceeded complications reported in the NLST and mean costs ranged from $6,320 for minor complications to $56,845 for major ones.
Because complication rates after invasive diagnostic procedures were higher than rates reported in clinical trials, physicians and patients should be aware of potential risks of subsequent AEs and their high downstream costs in the SDM process, according to the authors.
Shih said a clearer picture of LCS complications will emerge in the next few years, as more direct screening data become available. But she added that results from the study, while tentative, should be included in SDM discussions for LCS.
“Our study provides additional information, but it isn’t intended to scare people,” she stated. “The reality is that out of the screening population, less than 5% would have abnormal findings that would trigger an invasive procedure.”
As part of its agreement to reimburse LCS for recipients (ages 55-77) with a ≥30 pack-year smoking history, the CMS requires separate SDM before LDCT LCS. But few enrollees (9%) had a separate SDM that informed their decisions to undergo a LDCT LCS. Moreover, nearly a third of the 2,154 enrollees who received a SDM visit opted not to undergo a LDCT LCS.
Rita Redberg, MD, of the University of California San Francisco and JAMA Internal Medicine‘s editor-in-chief, noted in an editorial that the SDM study adds “to our knowledge of lung cancer screening by showing that the majority of Medicare beneficiaries are also not having a mandated SDM visit before they undergo LDCT” LCS. She was referencing prior evidence from the literature showing rare SDM visits among the privately insured population in this statement.
Of the enrollees who had a SDM visit, about 40% did not undergo LCS. Redberg posited that these decisions were likely driven by “a high false-positive rate, a high chance of incidental findings and subsequent need for invasive procedures, and small chance of benefit.”
“These data suggest that the current use of resources for lung cancer screening should be reexamined and efforts should be refocused on smoking cessation and smoking prevention to prevent lung cancer and improve health,” she stated.
Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco