Risk-based lung cancer screening performance in a universal healthcare setting.

Globally, lung cancer is the leading cause of cancer death. Previous trials demonstrated that low-dose computed tomography lung cancer screening of high-risk individuals can reduce lung cancer mortality by 20% or more. Lung cancer screening has been approved by major guidelines in the United States, and over 4,000 sites offer screening. Adoption of lung screening outside the United States has, until recently, been slow. Between June 2017 and May 2019, the Ontario Lung Cancer Screening Pilot successfully recruited 7,768 individuals at high risk identified by using the PLCOm2012noRace lung cancer risk prediction model. In total, 4,451 participants were successfully screened, retained and provided with high-quality follow-up, including appropriate treatment. In the Ontario Lung Cancer Screening Pilot, the lung cancer detection rate and the proportion of early-stage cancers were 2.4% and 79.2%, respectively; serious harms were infrequent; and sensitivity to detect lung cancers was 95.3% or more. With abnormal scans defined as ones leading to diagnostic investigation, specificity was 95.5% (positive predictive value, 35.1%), and adherence to annual recall and early surveillance scans and clinical investigations were high (>85%). The Ontario Lung Cancer Screening Pilot provides insights into how a risk-based organized lung screening program can be implemented in a large, diverse, populous geographic area within a universal healthcare system.

Selection of individuals for lung cancer screening based on risk prediction model performance and economic factors - The Ontario experience.

INTRODUCTION: Randomized controlled trials have shown that screening with computed tomography reduces lung cancer mortality but is most effective when applied to high-risk individuals. Accurate lung cancer risk prediction models effectively select individuals for screening. Few pilots or programs have implemented risk models for enrolling individuals for screening in real-world, population-based settings. This report describes implementation of the PLCOm2012 risk prediction model in the Ontario Health (Cancer Care Ontario) lung cancer screening Pilot. METHODS: In the Pilot's Health Technology Assessment, 576 categorical age/pack-years/quit-years scenarios were evaluated using MISCAN microsimulation modeling and cost-effectiveness analyses. A preferred model was selected which provided the most life-years gained per cost. The PLCOm2012 was compared to the preferred MISCAN scenario at a threshold that yielded the same number eligible (risk ≥2.0 %/6-years). RESULTS: The PLCOm2012 had significantly higher sensitivity and predictive value (68.1 % vs 59.6 %, p < 0.0001; 4.90 % vs 4.29 %, p = 0.044), and an Expert Panel selected it for use in the Pilot. The Pilot cancer detection rate was significantly higher than in the NLST (p = 0.009) or NELSON (p = 0.003) and there was a significant shift to early stage compared to historical Ontario Cancer Registry statistics (p < 0.0001). Pre- and post-Pilot evaluations found that conducting quality risk assessments were not excessively time consuming or difficult, and participants' satisfaction was high. CONCLUSIONS: The PLCOm2012 was efficiently implemented in the Pilot in a real-world setting and is being used to transition into a provincial program. Compared to categorical age/pack-years/quit-years criteria, risk assessment using the PLCOm2012 can lead to effective and efficient screening.

Organized Lung Cancer Screening Pilot: Informing a Province-Wide Program in Ontario, Canada.

BACKGROUND: Lung cancer is the leading cause of cancer deaths in Ontario. The National Lung Screening Trial demonstrated that screening with low-dose computed tomography (LDCT) reduces lung cancer mortality. METHODS: In June 2017, Ontario Health (Cancer Care Ontario) initiated a pilot for lung cancer screening to inform implementation of a province-wide initiative. The screening pathway includes targeted recruitment strategies, the Tammemägi risk prediction model (PLCOm2012) to determine eligibility, opt-out smoking cessation services for all current smokers, use of the Lung-RADS scoring system to guide abnormal results management, and screening navigators providing end-to-end support. Referral criteria include being 55 years of age to 74 years of age and a current or former daily cigarette smoker for greater than or equal to 20 years, while the screening eligibility criterion is a PLCOm2012 risk greater than or equal to 2% in 6 years. Selected results of the interim pilot evaluation are presented. Four hospitals contributed data in the first year of the pilot. RESULTS: During 2017 to 2018, 4205 Ontarians were recruited, 3234 risk assessments were conducted, and 2151 (66.5%) individuals were eligible for screening. Baseline LDCT scans were performed in 1624 (50.2%) individuals. Diagnostic evaluation in 120 (7.4%) individuals identified 28 (1.7%) with lung cancer, and proportions of stage I to II and stage III to IV were 71% and 29%, respectively. Of those recruited, 1443 (34.3%) individuals were smokers and 1326 (91.9%) accepted smoking cessation services. CONCLUSIONS: The pilot is the largest in Canada and aligns with International Agency for Research on Cancer standards for population-based, organized cancer screening. Recruitment of high-risk individuals, high rates of smoking cessation program acceptance, and detection of early-stage cancers are demonstrated.

One, two and three-dimensional ultrasound measurements of carotid atherosclerosis before and after cardiac rehabilitation: preliminary results of a randomized controlled trial.

BACKGROUND: It is still not known how patients who are post-transient ischemic attack (TIA) or post-stroke might benefit from prospectively planned comprehensive cardiac rehabilitation (CCR). In this pilot evaluation of a larger ongoing randomized-controlled-trial, we evaluated ultrasound (US) measurements of carotid atherosclerosis in subjects following TIA or mild non-disabling stroke and their relationship with risk factors before and after 6-months of CCR. METHODS: Carotid ultrasound (US) measurements of one-dimensional intima-media-thickness (IMT), two-dimensional total-plaque-area (TPA), three-dimensional total-plaque-volume (TPV) and vessel-wall-volume (VWV) were acquired before and after 6-months CCR for 39 subjects who had previously experienced a TIA and provided written informed consent to participate in this randomized controlled trial. We maintained blinding for this ongoing study by representing treatment and control groups as A or B, although we did not identify which of A or B was treatment or control. Carotid IMT, TPA, TPV and VWV were measured before and after CCR as were changes in body mass index (BMI), total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides (TG), systolic blood pressure (SBP) and diastolic blood pressure (DBP). RESULTS: There were no significant differences in US measurements or risk factors between groups A and B. There was no significant change in carotid ultrasound measurements for group A (IMT, p = .728; TPA, p = .629; TPV, p = .674; VWV, p = .507) or B (IMT, p = .054; TPA, p = .567; TPV, p = .773; VWV, p = .431) at the end of CCR. There were significant but weak-to-moderate correlations between IMT and VWV (r = 0.25, p = .01), IMT and TPV (r = 0.21, p = .01), TPV and TPA (r = 0.60, p < .0001) and VWV and TPV (r = 0.22, p = .02). Subjects with improved TC/HDL ratios showed improved carotid VWV although, this was not statistically significant. CONCLUSION: In this preliminary evaluation, there were no significant differences in carotid US measurements in the control or CCR group; a larger sample size and/or longer duration is required to detect significant changes in US or other risk factor measurements.

The relationship of carotid three-dimensional ultrasound vessel wall volume with age and sex: comparison to carotid intima-media thickness.

The relationship of three-dimensional ultrasound (3DUS)-derived carotid vessel wall volume (VWV) was evaluated with respect to age and sex. B-mode and 3DUS images were acquired for 316 subjects from diverse groups including obese primary prevention, diabetic nephropathy, renal transplant and rheumatoid arthritis populations. The relationship for intima-media thickness (IMT) and VWV with age and sex were determined using Pearson-product-moment correlations. Mean IMT (r = 0.18, p = 0.001) and VWV (r = 0.24, p < 0.01) correlated modestly with age. There were modest correlations in males (IMT, r = 0.19, p = 0.003; VWV, r = 0.34, p < 0.001) and in females for IMT and age (r = 0.30, p = 0.007) but not between 3DUS VWV and age in females (r = 0.10, p = 0.4). Significant associations between plaque and VWV (r = 0.36, p = 0.001) but not IMT suggest different correlations in females that may be attributed to plaque.