Controlled Lung Cancer Screening Trial Research Articles

Direct and indirect healthcare costs of lung cancer CT screening in Denmark: a registry study

IntroductionA study based on the Danish Randomised Controlled Lung Cancer Screening Trial (DLCST) calculated the healthcare costs of lung cancer screening by comparing costs in an intervention group with a...

Determination of the optimal screen interval in low-dose CT lung cancer screening: are we there yet?

In view of the prospective results of the largest randomized controlled lung cancer screening trial worldwide, the National Lung Screening Trial (NLST), and baseline results of other trials, interest in low-dose chest CT for lung cancer screening in high-risk individuals is increasing. In 2011, the U.S. NLST demonstrated that screening using annual low-dose chest CT reduces lung cancer mortality by 15–20% compared to screening by chest radiography (1). This result was translated by several U.S. medical associations, including the U.S. Preventive Services Task Force, into a recommendation to screen subjects at high-risk for developing lung cancer by annual low-dose chest CT (2-5). According to the recommendation of the U.S. Preventive Services Task Force, all individuals between 55 and 80 years old who smoked at least 30 pack-years and quit not longer than 15 years ago are eligible for lung cancer screening. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery (5).

Biochemical verification of the self-reported smoking status of screened male smokers of the Dutch–Belgian randomized controlled lung cancer screening trial

BackgroundSmoking is the main cause of lung cancer, so data linked to smoking behaviour are important in lung cancer screening trials. However, self-reporting data concerning smoking behaviour are mainly used. The aim of this study was to biochemically determine the validity and reliability of self-reported smoking status among smokers at high risk for developing lung cancer participating in the Dutch-Belgian lung cancer screening (NELSON) trial. MethodFor this sub study, a random sample of 475 men was selected who were scheduled for the fourth screening round in the NELSON trial. They were asked to complete a short questionnaire to verify the smoking behaviour for the previous seven days and a blood sample was collected to measure the cotinine level. The validity (sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV)) and reliability (Kappa) of the self-reported smoking status compared to the cotinine level (as golden standard) were determined. ResultsBoth a completed questionnaire as well as a cotinine level were available for 199 (41.9%) participants. Based on these data, Se and Sp were respectively 98% (95%-Confidence Interval (CI): 91–99) and 98% (95%-CI: 93–100). PPV and NPV were 98% and 96% and Kappa was 0.96. ConclusionIn conclusion, the validity of the self-reported smoking status turned out to be reliable amongst men at high risk for developing lung cancer who participate in the NELSON lung cancer screening trial.

Psychosocial consequences in the Danish randomised controlled lung cancer screening trial (DLCST)

ObjectivesTo measure the psychosocial consequences in the Danish lung cancer screening trial (DLCST) and compare those between the computed tomography (CT) group and the control group. Materials and methodsThis study was a single centre randomised controlled trial with five annual screening rounds. Healthy current or former heavy smokers aged 50–70 years (men and women) were randomised 1:1 to a CT group and a control group. Heavy smokers were defined by having smoked ≥20 pack years and former smokers by being abstinent ≤10 years. Both groups were invited annually to the screening clinic to complete the validated lung-cancer-specific questionnaire consequences of screening lung cancer (COS-LC). The CT group was also offered a low dose CT scan of the lungs. The COS-LC measures nine scales with psychosocial properties: Anxiety, Behaviour, Dejection, Negative impact on sleep, Self-blame, Focus on Airway Symptoms, Stigmatisation, Introvert, and Harm of Smoking. Results4104 participants were randomised to the DLCST and the COS-LC completion rates for the CT group and the control group were 95.5% and 73.6%, respectively. There was a significant increase in negative psychosocial consequences from baseline through rounds 2–5 for both the CT group and the control group (mean increase >0, p<.0001 for 3 of 4 possible scales). During rounds 2–5 the control group experienced significantly more negative psychosocial consequences in seven of nine scales compared with the CT group (mean Δ score >0 and p<.033). ConclusionsLung cancer CT-screening trials induced more negative psychosocial reactions in both the CT group and the control group compared with the baseline psychosocial profile. The CT group experienced less negative psychosocial consequences compared with the control group, which might be explained by reassurance among those with normal screening results.Trial registration: ClinicalTrials.gov: NCT00496977.

Quality of Life and Healthcare Use in a Randomized Controlled Lung Cancer Screening Study

Understanding the quality of life of lung cancer screening program participants, and the impact of program participation on quality of life and healthcare use, will help in the assessment of the value of screening. Determine the quality of life of participants in a lung cancer screening study and assess the effect of an abnormal screening finding on quality of life and healthcare use. Quality-of-life measures and data on the use of healthcare services were collected prospectively during a randomized controlled lung cancer screening trial using chest radiography with computer-aided detection. Comparisons of baseline measures were made with U.S. population norms for the EuroQol 5-Dimension index. The impact of receiving a message of the presence of a lung nodule was assessed for all measures. A total of 1,424 subjects participated. Twenty-five actionable nodules were reported. Baseline EuroQol 5-Dimension index scores were higher than U.S. population norms (P < 0.0001). The EuroQol 5-Dimension index score and St. George's Respiratory Questionnaire symptom score showed a significant change toward poorer quality of life after notification of the presence of a lung nodule (0.940 vs. 0.877, P = 0.022, and 25.7 vs. 34.0, P = 0.005, respectively). Chest imaging within 6 months of the screening examination occurred more frequently in those notified of a lung nodule (25.5 vs. 9.3%, P = 0.002). Those who choose to enter a lung cancer screening program have a high baseline quality of life. The report of an abnormal screening finding can lower the quality of life and lead to increased chest imaging. Clinical trial registered with www.clinicaltrials.gov (NCT01663155).

Generalisability of the results of the Dutch–Belgian randomised controlled lung cancer CT screening trial (NELSON): Does self-selection play a role?

The degree of self-selection in the Dutch–Belgian randomised controlled lung cancer screening trial (NELSON) was determined to assess the generalisability of the study results. 335,441 (mainly) men born in 1928–1953 received a questionnaire. Of the respondents (32%), eligible subjects were invited to participate (19%). Fifty-five percent gave informed consent and was randomised. Background characteristics were compared between male respondents on the first questionnaire (n=92,802), eligible subjects among them (n=18,570) and those randomised (n=10,627) and Statistics Netherlands 2002–2005 (SN) (n=5289) or GLOBE study-data (Dutch cohort) (n=696).Initial respondents were less likely to be highly educated (ORadj=0.84; 95% CI: 0.74–0.96) and comprised of significantly less current smokers (ORadj=0.65; 95% CI: 0.61–0.69) compared to the general population. These current smokers smoked more heavily (ORadj=1.23; 95% CI: 1.10–1.37), but for a shorter time-period (respondents: 31, SN: 42 years, p<0.001). Age, general health, BMI, alcohol use and cancer prevalence were comparable. The randomised population was younger (Age 50–65) (randomised subjects: 85.3%, SN: 72% (p<0.01)) comprised of more heavy current smokers (OR=2.08; 95% CI: 1.75–2.44), that smoked for a shorter period of time (randomised subjects: 37, SN_selection: 42 years (p<0.001)).Both the respondents (32%) of the first questionnaire as well as the randomised population of the NELSON trial appeared to differ slightly on smoking characteristics, but the differences were limited and probably balance each other. Results of the NELSON trial will be roughly applicable to the Dutch and probably other populations that fulfil our selection criteria.

Coronary Artery Calcium Can Predict All-Cause Mortality and Cardiovascular Events on Low-Dose CT Screening for Lung Cancer

Performing coronary artery calcium (CAC) screening as part of low-dose CT lung cancer screening has been proposed as an efficient strategy to detect people with high cardiovascular risk and improve outcomes of primary prevention. This study aims to investigate whether CAC measured on low-dose CT in a population of former and current heavy smokers is an independent predictor of all-cause mortality and cardiac events. We used a case-cohort study and included 958 subjects 50 years old or older within the screen group of a randomized controlled lung cancer screening trial. We used Cox proportional-hazard models to compute hazard ratios (HRs) adjusted for traditional cardiovascular risk factors to predict all-cause mortality and cardiovascular events. During a median follow-up of 21.5 months, 56 deaths and 127 cardiovascular events occurred. Compared with a CAC score of 0, multivariate-adjusted HRs for all-cause mortality for CAC scores of 1-100, 101-1000, and more than 1000 were 3.00 (95% CI, 0.61-14.93), 6.13 (95% CI, 1.35-27.77), and 10.93 (95% CI, 2.36-50.60), respectively. Multivariate-adjusted HRs for coronary events were 1.38 (95% CI, 0.39-4.90), 3.04 (95% CI, 0.95-9.73), and 7.77 (95% CI, 2.44-24.75), respectively. This study shows that CAC scoring as part of low-dose CT lung cancer screening can be used as an independent predictor of all-cause mortality and cardiovascular events.

The effectiveness of a computer-tailored smoking cessation intervention for participants in lung cancer screening: A randomised controlled trial

BackgroundLung cancer screening might be a teachable moment for smoking cessation intervention. The objective was to investigate whether a tailored self-help smoking cessation intervention is more effective in inducing smoking cessation compared to a standard brochure in male smokers who participate in the Dutch-Belgian randomised controlled lung cancer screening trial (NELSON trial). MethodsTwo random samples of male smokers who had received either a standard brochure (n=642) or a tailoring questionnaire for computer-tailored smoking cessation information (n=642) were sent a questionnaire to measure smoking behaviour two years after randomisation. ResultsTwenty-three percent of the male smokers in the tailored information group returned a completed tailoring questionnaire and thus received the tailored advice. The prolonged smoking abstinence was slightly, but not statistically significant, lower amongst those randomised in the tailored information group (12.5%) compared with the brochure group (15.6%) (OR=0.77 (95%-CI: 0.56–1.06). The level of education and intention to quit smoking significantly predicted smoking cessation at follow-up (p<0.05). The majority of the respondents did not recall whether and which smoking cessation intervention they had received at randomisation after 2-years of follow-up. ConclusionThe current study showed no advantage of tailored smoking cessation information over standard self-help information amongst male smokers with a long term smoking history who participate in a lung cancer screening trial after two years of follow-up. However, the low percentage participants who actually received the tailored advice limited the ability to find an advantage.

Lung cancer screening and smoking abstinence: 2 year follow-up data from the Dutch–Belgian randomised controlled lung cancer screening trial

BackgroundLung cancer screening may provide a new opportunity for attempts to quit among smokers or might delay smoking cessation, but studies to date failed to provide evidence for this. This...

Pulmonary Nodules: Volume Repeatability at Multidetector CT Lung Cancer Screening

To assess in vivo volumetric repeatability of an automated software algorithm in pulmonary nodules detected during a lung cancer screening trial. This study was approved by an institutional review board. Written informed consent was obtained from all participants. Data were collected from the Multicentric Italian Lung Detection project, a randomized controlled lung cancer screening trial. The first 1236 consecutive baseline computed tomographic (CT) studies performed at the Istituto Nazionale Tumori of Milan were evaluated. Among the enrolled participants, those who underwent repeat low-dose CT after 3 months and had at least one indeterminate nodule with a volume of more than 60 mm(3) (diameter of 4.8 mm or greater) were considered. Nonsolid, part-solid, and pleural-based nodules were excluded from this study. A descriptive analysis was performed by calculating means and standard deviations of nodule volumes at three assessment times (at baseline and 3 and 12 months later). The volume measurement repeatability was determined by using the approach described by Bland and Altman. One hundred one subjects (70 men, 31 women; mean age, 58 years) with 233 eligible nodules (mean volume, 98.3 mm(3); range, 5-869 mm(3)) were identified. The 95% confidence interval for difference in measured volumes was in the range of +/-27%. About 70% of measurements had a relative difference in nodule volume of less than 10%. No malignant lesions were registered during the follow-up of these subjects. Semiautomatic volumetry is sufficiently accurate and repeatable and may be useful in assisting with lung nodule management in a lung cancer screening program.