Psychosocial consequences of false positives in the Danish Lung Cancer CT Screening Trial: a nested matched cohort study.

OBJECTIVES: Lung cancer CT screening can reduce lung cancer mortality, but high false-positive rates may cause adverse psychosocial consequences. The aim was to analyse the psychosocial consequences of false-positive lung cancer CT screening using the lung cancer screening-specific questionnaire, Consequences of Screening in Lung Cancer (COS-LC). DESIGN AND SETTING: This study was a matched cohort study, nested in the randomised Danish Lung Cancer Screening Trial (DLCST). PARTICIPANTS: Our study included all 130 participants in the DLCST with positive CT results in screening rounds 2-5, who had completed the COS-LC questionnaire. Participants were split into a true-positive and a false-positive group and were then matched 1:2 with a control group (n=248) on sex, age (±3 years) and the time of screening for the positive CT groups or clinic visit for the control group. The true positives and false positives were also matched 1:2 with participants with negative CT screening results (n=252). PRIMARY OUTCOMES: Primary outcomes were psychosocial consequences measured at five time points. RESULTS: False positives experienced significantly more negative psychosocial consequences in seven outcomes at 1 week and in three outcomes at 1 month compared with the control group and the true-negative group (mean ∆ score >0 and p<0.001). True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group. No long-term psychosocial consequences were identified either in false positives or true positives. CONCLUSIONS: Receiving a false-positive result in lung cancer screening was associated with negative short-term psychosocial consequences. These findings contribute to the evidence on harms of screening and should be taken into account when considering implementation of lung cancer screening programmes. TRIAL REGISTRATION NUMBER: NCT00496977.

Did psychosocial status, sociodemographics and smoking status affect non-attendance in control participants in the Danish Lung Cancer Screening Trial? A nested observational study.

OBJECTIVES: We investigated if psychosocial status, sociodemographics and smoking status affected non-attendance in the control group in the randomised Danish Lung Cancer Screening Trial (DLCST). DESIGN AND SETTING: This study was an observational study nested in the DLCST. Due to large non-attendance in the control group in the second screening round we made an additional effort to collect questionnaire data from non-attenders in this group in the third screening round. We used a condition-specific questionnaire to assess psychosocial status. We analysed the differences in psychosocial status in the third and preceding rounds between non-attenders and attenders in the control group in multivariable linear regression models adjusted for sociodemographics and smoking status reported at baseline. Differences in sociodemographics and smoking status were analysed with χ2 tests (categorical variables) and t-tests (continuous variables). PRIMARY OUTCOME MEASURE: Primary outcome was psychosocial status. PARTICIPANTS: All control persons participating in the third screening round in the DLCST were included. RESULTS: Non-attenders in the third round had significantly worse psychosocial status than attenders in the scales: 'behaviour' 0.77 (99% CI 0.18 to 1.36), 'self-blame' 0.59 (99% CI 0.14 to 1.04), 'focus on airway symptoms' 0.22 (99% CI 0.08 to 0.36), 'stigmatisation' 0.51 (99% CI 0.16 to 0.86), 'introvert' 0.56 (99% CI 0.23 to 0.89) and 'harms of smoking' 0.35 (99% CI 0.11 to 0.59). Moreover, non-attenders had worse scores than attendees in the preceding screening rounds. Non-attenders also reported worse sociodemographics at baseline. CONCLUSIONS: Non-attenders had a significantly worse psychosocial status and worse sociodemographics compared with attenders. The results of our study contribute with evidence of non-response and attrition driven by psychosocial status, which in turn may be influenced by the screening intervention itself. This can be used to adjust cancer screening trial results for bias due to differential non-attendance. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov Protocol Registration System (NCT00496977).

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

INTRODUCTION: A 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 control group. Participants in both groups, however, experienced significantly increased negative psychosocial consequences after randomisation. Substantial participation bias has also been documented: The DLCST participants reported fewer negative psychosocial aspects and experienced better living conditions compared with the random sample. OBJECTIVE: To comprehensively analyse the costs of lung cancer CT screening and to determine whether invitations to mass screening alter the utilisation of the healthcare system resulting in indirect costs. Healthcare utilisation and costs are analysed in the primary care sector (general practitioner psychologists, physiotherapists, other specialists, drugs) and the secondary care sector (emergency room contacts, outpatient visits, hospitalisation days, surgical procedures and non-surgical procedures). DESIGN: To account for bias in the original trial, the costs and utilisation of healthcare by participants in DLCST were compared with a new reference group, selected in the period from randomisation (2004-2006) until 2014. SETTING: Four Danish national registers. PARTICIPANTS: DLCST included 4104 current or former heavy smokers, randomly assigned to the CT group or the control group. The new reference group comprised a random sample of 535 current or former heavy smokers in the general Danish population who were never invited to participate in a cancer screening test. MAIN OUTCOME MEASURES: Total healthcare costs including costs and utilisation of healthcare in both the primary and the secondary care sector. RESULTS: Compared with the reference group, the participants in both the CT group (offered annual CT screening, lung function test and smoking counselling) and the control group (offered annual lung function test and smoking counselling) had significantly increased total healthcare costs, calculated at 60% and 48% respectively. The increase in costs was caused by increased use of healthcare in both the primary and the secondary sectors. CONCLUSION: CT screening leads to 60% increased total healthcare costs. Such increase would raise the expected annual healthcare cost per participant from EUR 2348 to EUR 3756. Cost analysis that only includes costs directly related to the CT scan and follow-up procedures most likely underestimates total costs. Our data show that the increased costs are not limited to the secondary sector. TRIAL REGISTRATION NUMBER: NCT00496977.

[Lung cancer screening with low dose CT requires careful consideration].

Results from the American National Lung Screening Trial (NLST) show a significant reduction in lung cancer and all-cause mortality in a high risk population screened with annual low-dose CT. Handling of pulmonary nodules, false positive tests, overdiagnosis, psychosocial consequences and cost-efficiency etc. are all aspects that require careful consideration. This paper gives an overview of the current knowledge on these issues. Before a recommendation can be made, we need an overall evaluation of both the benefits and harms in CT screening for lung cancer.

[Lung cancer screening with low-dose CT - Danish and international results].

Lung cancer is the cancer type that causes the largest number of deaths in Denmark. With advances in medical imaging and widespread use of computed tomography (CT), it is possible to detect even small abnormalities in lung tissue. This has led to a great interest in lung cancer screening with low-dose CT and launching of randomised screening trials worldwide. This paper gives an overview of the current lung cancer screening trials in Denmark and internationally and focuses on main lung cancer findings and mortality results.

CT screening for lung cancer brings forward early disease. The randomised Danish Lung Cancer Screening Trial: status after five annual screening rounds with low-dose CT.

BACKGROUND: The effects of low-dose CT screening on disease stage shift, mortality and overdiagnosis are unclear. Lung cancer findings and mortality rates are reported at the end of screening in the Danish Lung Cancer Screening Trial. METHODS: 4104 men and women, healthy heavy smokers/former smokers were randomised to five annual low-dose CT screenings or no screening. Two experienced chest radiologists read all CT scans and registered the location, size and morphology of nodules. Nodules between 5 and 15 mm without benign characteristics were rescanned after 3 months. Growing nodules (>25% volume increase and/or volume doubling time<400 days) and nodules >15 mm were referred for diagnostic workup. In the control group, lung cancers were diagnosed and treated outside the study by the usual clinical practice. RESULTS: Participation rates were high in both groups (screening: 95.5%; control: 93.0%; p<0.001). Lung cancer detection rate was 0.83% at baseline and mean annual detection rate was 0.67% at incidence rounds (p=0.535). More lung cancers were diagnosed in the screening group (69 vs. 24, p<0.001), and more were low stage (48 vs 21 stage I-IIB non-small cell lung cancer (NSCLC) and limited stage small cell lung cancer (SCLC), p=0.002), whereas frequencies of high-stage lung cancer were the same (21 vs 16 stage IIIA-IV NSCLC and extensive stage SCLC, p=0.509). At the end of screening, 61 patients died in the screening group and 42 in the control group (p=0.059). 15 and 11 died of lung cancer, respectively (p=0.428). CONCLUSION: CT screening for lung cancer brings forward early disease, and at this point no stage shift or reduction in mortality was observed. More lung cancers were diagnosed in the screening group, indicating some degree of overdiagnosis and need for longer follow-up.